[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"nicotine-dependence\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:nicotine-dependence":29},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,32,0,25,[9,47,83,110,135,161,184,213,238,264,277,305,328,351,378,404,426,448,469,502,521,543,559,581,602],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":30,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100053792","orexin-s-role-in-the-neurobiology-of-substance-use-disorder-100053792",false,"NCT05630781","Orexin s Role in the Neurobiology of Substance Use Disorder","Orexin's Role in The Neurobiology of Substance Use Disorder","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\nAll Participants\n\n* Participants will be volunteers between the ages of 18-60 at the time of enrollment in the study (both sexes). Justification: Many neural processes change with age, and these changes could introduce unwanted variability in both behavioral and MRI signals.\n* Able and willing to provide written informed consent, which includes agreement to all Lifestyle Considerations at the time of study consent.\n\nNicotine Dependence Arm\n\n-Participants must smoke\u002Fvape a minimum of 4 times per week with a urine cotinine level corresponding to nicotine user status for the specific test being used (typically corresponding to a urine cotinine above about 200 ng\u002Fml) and have been smoking or vaping consistently for at least the past year (excluding quit attempts).\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\nAll Participants\n\n* Participants cannot meet DSM-5 criteria for lifetime and\u002For current psychotic disorders such as bipolar disorder, schizophrenia, schizoaffective disorder.\n* Participants cannot meet DSM-5 criteria for current substance use disorders other than nicotine and marijuana and cannot meet criteria for current moderate or severe alcohol use disorder.\n* Participants cannot have positive illicit drug and alcohol screen on each study visit other than for nicotine or marijuana.\n* Medications with the potential to depress CNS function will be assessed by the MAI, PI, or a physician's assistant and participants excluded as necessary.\n* Participants cannot have a history of major head trauma resulting in cognitive impairment, seizure, or other neurological disorders.\n* Participant cannot have any history of neurological disorders, including seizures, epilepsy, or cognitive impairment which may impact MRI metrics.\n* Participants cannot be pregnant or breastfeeding. Justification: The impact of suvorexant on the developing fetus and infant.\n* Individuals with severe hepatic impairment will be excluded\n* Participants cannot be obese as determined by a Body Mass Index (BMI) of greater than 35.\n* Participants cannot be using a strong CYP3A inhibitor\u002Finducer (metabolism by CYP3A is the major elimination pathway for suvorexant)\n* Participants cannot have any past or present significant cardiac disorders or cerebrovascular conditions such as palpitations, tachycardia, use of the cardiac medication Digoxin, arrhythmias, acute coronary syndrome, ischemic heart disease, or uncontrolled hypertension.\n* Participants cannot have narcolepsy.\n* Participants cannot self-report complex sleep behaviors such as sleep driving, preparing and eating food or making phone calls.\n* Participants with Major Depressive Disorder who are using medication must be stable on medication for 3 months.\n* Subjects with suicidal ideation where outpatient treatment is determined unsafe.\n* Subjects that cannot speak English. Justification: To include non-English speakers, we would have to translate the consent and other study documents and hire and train bilingual staff, which would require resources that we do not have and could not justify, given the small sample size for each experiment. Additionally, the data integrity of some of the cognitive tasks and standardized questionnaires used in this study would be compromised as they have only been validated in English. Most importantly, ongoing communication regarding safety procedures is necessary when participants are undergoing MRI procedures. The inability to effectively communicate MRI safety procedures in a language other than English could compromise the safety of non-English speaking participants.\n* Contraindication to MRI as determined by MRI Safety Screening form.\n\nNicotine Dependent Arm\n\n* Participants cannot self-report compromised respiratory function such as severe obstructive sleep apnea or severe chronic obstructive pulmonary disease.\n* Participants cannot meet DSM-5 criteria for moderate or severe ADHD.\n\nControl Arm\n\n* May not have used any nicotine product more than once per week in the past year. Must have an expired carbon monoxide level of less than or equal to 5 ppm.\n* Must not have a history of excessive substance use that may impact reward function, as evaluated by the PI, MAI, and\u002For designee.\n* Current pharmacological treatment for opioid use disorder (i.e., use of methadone)\n* May not have (or currently be treated\u002Fmedicated for) any diagnoses\u002Fconditions contraindicated for use of methylphenidate.\n* Participants may not have a diagnosis of moderate or severe ADHD (irrespective of medication use) or present with undiagnosed ADHD during screening.",true,"ALL","18 Years","60 Years",{"count":22,"type":23},140,"ESTIMATED","INTERVENTIONAL",[26],"NA","Study Description:\n\nDespite the availability of pharmacotherapy for some substance use disorders, relapse vulnerability is still a significant issue. This suggests medications with alternative mechanisms of action should be explored to address this unmet need. Substantial preclinical research indicates that orexin antagonism blunts the internally and externally triggered motivation to attain abused substances. This research project will translate these preclinical findings into the clinical domain by administering the FDA approved orexin antagonist, suvorexant, to those with a substance use disorder. Suvorexant s ability to blunt neurobiological correlates of substance misuse will be assessed. This will be assessed following acute and repeated drug administration. Baseline individual differences will be considered to determine whether neurobiological variance influences suvorexant s impact in those with nicotine dependence. In an independent arm, the interaction between suvorexant and a dopamine agonist (methylphenidate) on cognitive function will be assessed in non-smoking individuals.\n\nObjectives:\n\nThe objective is to determine the acute and chronic impact of the orexin antagonist, suvorexant, on neurobiological and behavioral factors linked with substance use disorders. Whether such effects are mediated by baseline characteristics will be tested. Given suvorexant is an FDA approved treatment for insomnia, sleep will be evaluated as well in the nicotine dependent arm.\n\nEndpoints:\n\nIn nicotine-dependent individuals, suvorexant s impact on brain function will be assessed several ways by evaluating: 1) resting function, 2) reactivity to drug cues, 3) reactivity to non-drug related cognitive tasks. Sleep and nicotine use will be measured throughout the study period. In those without nicotine-dependence, the impact of suvorexant and the interaction of acute methylphenidate and suvorexant on brain function will be assessed. This arm will provide insight into how suvorexant impacts reward\u002Fcognition as well as impacts the pharmacological influence of methylphenidate on those same measures.\n\nStudy Population:\\\u003CTAB\\>\n\nNicotine dependence arm:140 subjects; Volunteers who are between the ages of 18-60 and are daily smokers\u002Fvapers.\n\nControl arm: 80 subjects; Volunteers who are between the ages of 18-60 and are non-smokers\u002Fvapers\n\nThis study will be conducted at the NIDA-IRP, Biomedical Research Center, in Baltimore, MD.\n\nDescription of Study Intervention:\n\nNicotine dependence arm: Suvorexant at 10 mg single dose, and Suvorexant at 10 mg daily for approximately 7 days.\n\nControl arm: 1. Tolerability visit with one MRI scan post-20mg methylphenidate, 4 acute drug administration (6-14 days in randomized order: 1. Placebo + placebo; 2. 20mg suvorexant + Placebo; 3. Placebo + 40mg methylphenidate; 4. 20 mg suvorexant + 40mg methylphenidate max)\n\nStudy Duration:\n\n5 years\n\nParticipant Duration:\n\n1-2 months",[29],"Nicotine Dependence",[31,32,33,29],"Orexin Antagonish","fMRI","Substance Use Disorder","RECRUITING","2026-07-10",{"date":37,"type":38},"2026-07-13","ACTUAL",{"date":40,"type":38},"2023-02-15",{"date":42,"type":23},"2027-12-31",{"name":44,"class":45},"National Institute on Drug Abuse (NIDA)","NIH",1,{"id":48,"slug":49,"hasResults":12,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":24,"phases":58,"briefSummary":60,"conditions":61,"keywords":66,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":46},"100053678","phase-4-varenicline-and-accelerated-transcranial-magnetic-stimulation-tms-for-quitting-nicotine-use-pilot-study-100053678","NCT07145866","Varenicline and Accelerated Transcranial Magnetic Stimulation (TMS) for Quitting Nicotine Use (Pilot Study)","Evaluation of Varenicline and Accelerated TMS for Reduction of Nicotine Use","V-TMS","Inclusion Criteria:\n\n* Age ≥ 18 and ≤65;\n* The ability to give written, informed consent;\n* Fluency in English;\n* Reported interest in quitting nicotine vaping or smoking within the next month;\n* Nicotine dependence, as defined by a score of ≥4 on the 10-question E-cigarette Dependence Inventory (ECDI) or Fagerström Test for Nicotine Dependence (FTND);\n* Smoke or vape nicotine daily for at least the past 90 days, as confirmed by self-report and timeline follow-back methods;\n* Saliva cotinine \\>30ng\u002FmL;\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding;\n* Use of smoking cessation pharmacotherapy in the past month;\n* Unwilling to abstain during the study from using smoking cessation aids other than those provided by the study;\n* Prior adverse drug reaction to varenicline;\n* Contraindication to D-Cycloserine (including allergy to D-Cycloserine, significant renal impairment or known kidney disease, pregnancy)\n* Receiving or planning to receive other TMS treatments or investigational drugs during course of participation\n* Contraindications to TMS (including seizures, metallic implants, severe existing tinnitus, etc.);\n* Contraindications to MRI (including presence of a cardiac pacemaker or pacemaker wires, metallic particles in the body, vascular clips in the head or previous neurosurgery, prosthetic heart valves, claustrophobia);\n* Inpatient psychiatric hospitalization or suicide attempts in the past six months, or recent active suicidal ideation or suicidal behavior identified at enrollment or baseline visits;\n* History of seizures and\u002For history of TBI subtypes associated with elevated seizure risk (e.g. penetrating injury and intraparenchymal hemorrhage)\n* History of unstable neurological illness or major medical illness, such as epilepsy or renal impairment, in the past six months, unless clearly resolved;\n* In the opinion of the investigators, evidence of active problem substance use severe enough to compromise ability to safely participate;\n* In the opinion of the investigators, unable to safely participate in this study and\u002For provide reliable data (e.g., claustrophobia, unable to tolerate TMS or MRI procedures, etc.).","65 Years",{"count":57,"type":23},30,[59],"PHASE4","The goal of this clinical trial is to learn if a combination of varenicline and enhanced accelerated Transcranial Magnetic Stimulation (aTMS) works to help adults quit using nicotine products. Researchers will compare varenicline + active aTMS with a single dose of D-Clycloserine to varenicline + sham (inactive) aTMS with a placebo pill to see the effect of enhanced aTMS on reaching abstinence. The main question it aims to answer is: Does receiving active enhanced aTMS + varenicline lead to higher abstinence rates and lower nicotine craving?\n\nParticipants will be asked to:\n\n* Complete 2 brain MRI scans\n* Take varenicline every day for 12 weeks\n* Quit using nicotine products at the end of the second week of varenicline\n* Complete one day of up to 20 TMS treatments\n* Take a single dose of D-Cycloserine medication on the day of TMS treatment\n* Complete 12 brief, weekly follow-up visits\n* Complete a brief daily survey each day that they take the study drug",[29,62,63,64,65],"Transcranial Magnetic Stimulation","Vaping","Smoking Cessation","Smoking (Tobacco) Addiction",[63,67,68,69,70,71,62,72,73],"Smoking","Nicotine","Adults","Cessation","Varenicline","TMS","D-Cycloserine","2026-07-09",{"date":37,"type":38},{"date":77,"type":23},"2026-08",{"date":79,"type":23},"2027-12",{"name":81,"class":82},"Massachusetts General Hospital","OTHER",{"id":84,"slug":85,"hasResults":12,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":4,"eligibilityCriteria":89,"healthyVolunteers":17,"sex":18,"minAge":90,"maxAge":91,"enrollmentInfo":92,"targetDuration":4,"studyType":24,"phases":94,"briefSummary":95,"conditions":96,"keywords":97,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":46},"100053214","braincraving-response-to-smoking-cues-after-oral-nicotine-pouch-use-100053214","NCT07698470","Brain\u002FCraving Response to Smoking Cues After Oral Nicotine Pouch Use","Cue-Exposure Response Evaluation: Brain Reactivity to ONPs","Inclusion Criteria:\n\n* Age 21 years - 55 years\n* Self-reported use of cigarettes within the past 30 days\n* Biochemical confirmation of cigarette use:\n\n  o Carbon monoxide (CO) breath sample ≥10 ppm\n* Fagerström Test for Nicotine Dependence (FTND) score ≥5, indicating moderate to high nicotine dependence\n* Fluent in English\n* Willing to try an oral nicotine pouch\n* Willing to abstain from nicotine for at least 12 hours prior to each experimental session\n\nExclusion Criteria:\n\n* Age younger than 21 years or older than 55 years\n* Biochemical evidence inconsistent with recent cigarette use:\n\n  o CO breath sample \\\u003C10 ppm\n* Expressed intent to reduce or quit nicotine use within the next 30 days\n* History of medical conditions contraindicated for nicotine use (e.g., uncontrolled hypertension, recent cardiac events)\n* Primary use of non-cigarette products (e.g., cigars, pipe tobacco, smokeless tobacco)\n* Prior use of oral nicotine products in their lifetime","21 Years","55 Years",{"count":93,"type":23},45,[26],"Oral nicotine pouches (ONPs) are non-combustible nicotine products that may reduce cigarette craving and smoking cue-induced brain activity, supporting their potential as harm-reduction tools for adults who smoke cigarettes. This within-subject, repeated-measures study will evaluate the acute effects of a single 6 mg oral nicotine pouch on subjective craving and prefrontal neural responses to smoking-related cues using functional near-infrared spectroscopy (fNIRS). Participants will complete assessments before and after nicotine pouch administration following overnight nicotine abstinence to characterize changes in craving and neural cue reactivity.",[29],[98,99,67,100,101],"Oral Nicotine Pouches","Oral Nicotine Products","Cigarettes","Harm Reduction","2026-07-07",{"date":37,"type":38},{"date":105,"type":38},"2026-04-30",{"date":107,"type":23},"2027-08",{"name":109,"class":82},"University of Southern California",{"id":111,"slug":112,"hasResults":12,"nctId":113,"briefTitle":114,"officialTitle":114,"acronym":115,"eligibilityCriteria":116,"healthyVolunteers":12,"sex":18,"minAge":117,"maxAge":19,"enrollmentInfo":118,"targetDuration":4,"studyType":24,"phases":120,"briefSummary":121,"conditions":122,"keywords":124,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":46},"100574900","behavioral-intervention-for-youth-to-promote-vaping-cessation-100574900","NCT06765291","Behavioral Intervention for Youth to Promote Vaping Cessation","VIA","Inclusion Criteria:\n\n* Age 14-18 inclusive\n* Self-report of at least weekly nicotine vaping (or use of other non combusted nicotine products, \"vaping\") for the prior ≥3 months\n* Self-report of no regular combusted tobacco use (i.e., 5 or more days of smoke smoked tobacco use per week) prior to enrollment and exhaled CO \\\u003C10 ppm for those with an in person baseline visit\n* Report willingness to try to quit or reduce vaping in the next 30 days\n* Able to understand study procedures and read and write in English or Spanish\n* Have a parent or legal guardian who is able to participate in the opt out process\n* Competent and willing to provide written informed consent (if age 18) or assent (if under 18)\n\nExclusion Criteria:\n\n* Use of a smoking cessation medication in the prior month (nicotine patch, gum, nasal spray, or inhaler, varenicline, bupropion)\n* Unwilling to abstain during the study from using smoking cessation aids other than those provided by the study\n* Unwilling to provide saliva or urine samples\n* Any condition or situation that would, in the investigator's opinion, make it unlikely that the participant could adhere safely to the study protocol","14 Years",{"count":119,"type":23},400,[26],"This study will test the hypothesis that the QuitVaping (QV) intervention and additional texting support will improve nicotine abstinence rates in adolescents as compared to Enhanced Usual Care (EUC: education about nicotine, vaping and addiction, advice to quit vaping, referral to TIQ texting support). Approximately 400 adolescents will be randomly assigned to one of two arms (1) QuitVaping intervention plus texting support to quit vaping and (2) EUC only.",[63,123,29],"Vaping Teens",[63,125,126],"Nicotine Depedence","Vaping Cessation","2026-06-26",{"date":129,"type":38},"2026-06-29",{"date":131,"type":38},"2025-06-18",{"date":133,"type":23},"2029-02-21",{"name":81,"class":82},{"id":136,"slug":137,"hasResults":12,"nctId":138,"briefTitle":139,"officialTitle":139,"acronym":4,"eligibilityCriteria":140,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":141,"enrollmentInfo":142,"targetDuration":4,"studyType":24,"phases":144,"briefSummary":145,"conditions":146,"keywords":148,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":46},"100135709","advanced-functional-and-structural-mri-techniques-for-neuropharmacological-imaging-100135709","NCT01036581","Advanced Functional and Structural MRI Techniques for Neuropharmacological Imaging","* Subjects must be between the ages of 18-80, be generally healthy and male or non-pregnant female. Smokers, non-smokers, drug using and non-drug using populations will participate in this study.\n\nINCLUSION CRITERIA:\n\nGeneral:\n\n* Male and non-pregnant female adults between the ages of 18-80.\n* All subjects must be able to provide informed consent.\n\nEXCLUSION CRITERIA:\n\nSubjects will be excluded if they:\n\n* Are pregnant. Urine pregnancy tests will be performed on all female volunteers of child-bearing potential before each experimental session.\n* Are unable to undergo MRI scanning due to implanted metallic devices (cardiac pacemaker or neurostimulator, some artificial joints, metal pins, surgical clips or other implanted metal parts including Copper 7 IUD) or claustrophobia.\n* Have major medical illnesses severe enough to impact data being gathered. Potential exclusions may include a history of chronic uncontrolled hypertension, diabetes, HIV, or other clinically significant medical conditions that may alter the signal being measured.\n* Have current major psychiatric disorders to include, but not limited to, mood, anxiety, psychotic disorders.\n* Have neurological illnesses severe enough to impact data being gathered. Potential exclusions may include seizure disorders, migraine, multiple sclerosis, movement disorders, or history of significant head trauma, CVA, or CNS tumor. The MAI will assess the severity in relation to the potential impact on data.\n* Are non-English speaking. Justification: There is no direct benefit to participants in this study, and some of the study procedures involve more than minimal risk. To include non-English speakers, we would have to translate the consent and other study documents and hire and train bilingual staff, which would require resources that we do not have and could not justify given the small sample size for each experiment. Additionally, the data integrity of some of the cognitive tasks and standardized questionnaires used in this study would be compromised as they have only been validated in English. Most importantly, ongoing communication regarding safety procedures is necessary when participants are undergoing MRI and TMS\u002FTRPMS procedures. The inability to effectively communicate MRI and TMS\u002FTRPMS safety procedures could compromise the safety of non-English speaking participants.\n* Are cognitively impaired, as assessed by medical history. A validated IQ test such as the WASI or Shipley-2 may also be considered. Justification: Cognitive impairment and learning disabilities are associated with alterations in brain regions used to accomplish tasks, and, therefore, may introduce significant variably into the data. Cognitive impairment may affect one s ability to give informed consent.\n\nSubjects to be considered for Non-Invasive Brain Stimulation (NIBS) will also be excluded if they:\n\n-Are unable to safely undergo a NIBS procedure as assessed by a TMS safety screening form.\n\nAdditional information will be gathered during screening for some experiments. As the purpose of this protocol is to develop imaging techniques, this information will be gathered as needed, depending on the phase of development and specific technique requirements. Based on the scientific and medical requirements of the particular experiment, participants may also be assessed for:\n\n* Age (some experiments may want to target a particular age range. For example, cognitive tasks generally exclude participants over 60, an age when cognitive issues tend to become more commonplace)\n* Left-handedness (if desired for a particular task)\n* Color-blindness (if using a task requiring color discrimination)\n* Drug use diagnosis\n* Use of psychoactive or vascularly active medications (if a functional fMRI technique that is sensitive to hemodynamic changes is being used). MAI discretion regarding timeframe of allowed use will be based on clinically relevant factors including drug half-life, pharmacology of the drug in question and pattern of use by the participant.","80 Years",{"count":143,"type":23},1000,[26],"Background:\n\n\\- Functional and structural magnetic resonance imaging (MRI) techniques have allowed researchers to map and study how the brain works when at rest and when engaged in specific tasks. MRI scans have provided more information about how drugs affect the brain, and about how drug addiction changes the brain and influences behavior, mood, and thinking processes. To better understand the underlying mechanism of drug addiction and to develop strategies for more effective treatment, researchers are interested in developing new MRI techniques to study the effects of addiction on the brain.\n\nObjectives:\n\n\\- To develop new functional and structural MRI techniques, and to evaluate their potential use in brain imaging studies related to addiction.\n\nEligibility:\n\n* Individuals between 18 and 80 years of age.\n* Participants may be smokers or nonsmokers, and may use drugs or not use drugs.\n\nDesign:\n\n* During the initial screening, participants will complete questionnaires about family and personal history, drug use, and other information as required by the researchers. Participants who will be asked to complete tasks during the MRI scan will be shown how to perform these tasks before the scanning session.\n* Before each study session, participants may be asked to complete some or all of the following: questions about their drug use during the last week, a breathalyzer test, a urine drug-use assessment, a urine pregnancy test, or a measure of carbon monoxide. Participants will also provide blood samples before the start of the scan.\n* For each scanning session, participants will have an MRI scan that will last approximately 2 hours.\n* MRI scans may include specific tasks to be performed during the scan, or an experiment that studies the brain's response to carbon dioxide.",[147,29],"Drug Abuse",[149,150,151,152,147],"Magnetic Resonance Imaging (MRI)","Functional Brain Imaging","Magnetic Resonance Spectroscopy","Diffusion Tensor Imaging","2026-06-23",{"date":155,"type":38},"2026-06-24",{"date":157,"type":38},"2003-10-24",{"date":159,"type":23},"2029-12-31",{"name":44,"class":45},{"id":162,"slug":163,"hasResults":12,"nctId":164,"briefTitle":165,"officialTitle":166,"acronym":4,"eligibilityCriteria":167,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":168,"enrollmentInfo":169,"targetDuration":4,"studyType":24,"phases":171,"briefSummary":172,"conditions":173,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":176,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":182,"locationsCount":46},"100585986","a-digital-intervention-act-on-vaping-app-for-vaping-cessation-in-young-adult-e-cigarette-users-100585986","NCT06909500","A Digital Intervention (ACT on Vaping App) for Vaping Cessation in Young Adult E-Cigarette Users","ACT on Vaping: Digital Therapeutic for Young Adult Vaping Cessation","Inclusion Criteria:\n\n* Age 18-30\n* Current weekly user of e-cigarette product(s) for the last 30 days\n* Has a smartphone; either an Android (running version 12 or higher) or iPhone (running iOS version 17 or higher, iPhone 11 or more recent)\n* Experience downloading and using one or more apps on their smartphone\n* Have a mobile data plan and\u002For access to WiFi to support the use of the ACT on Vaping app\n* Has access to text messaging\n* Has an email address\n* United States (US) resident, with a US mailing address\n* Willing to complete all study procedures\n* Comfortable reading and writing in English\n\nExclusion Criteria:\n\n* Currently using other tobacco cessation treatments at the time of screening, including pharmacotherapy or behavioral support (note: use of these treatment is allowable during trial participation)\n* Member of the same household as another research participant\n* Currently in prison\n* Google voice number as sole phone number, due to its association with fraudulent study entry attempts\n* Is ineligible per fraud prevention protocol\n* Employees\u002Ffamily of investigator or study center","30 Years",{"count":170,"type":23},1178,[26],"This clinical trial evaluates a smartphone application (app) called Acceptance and Commitment Therapy (ACT) on Vaping for helping young adults quit using electronic cigarettes (e-cigarettes). E-cigarettes pose numerous risks, particularly to youth and young adults. Addressing the high prevalence of e-cigarette use by young adults requires effective and accessible treatments to support current users to quit. Research shows this group prefers and benefits from newer methods of treatment delivery such as digital interventions. ACT on Vaping is a digital therapeutic intended to deliver behavioral therapy to young adults who vape to motivate and support abstinence from all nicotine and tobacco products. The app contains sessions that promote awareness of cues that trigger tobacco use and teach skills for responding to these triggers in a way that is tailored for the participant's readiness to quit. Receiving access to the ACT on Vaping app may be effective in helping young adults quit vaping.",[29,174],"Tobacco-Related Carcinoma","2026-06-18",{"date":177,"type":38},"2026-06-22",{"date":179,"type":23},"2026-07-15",{"date":181,"type":23},"2027-11-15",{"name":183,"class":82},"Fred Hutchinson Cancer Center",{"id":185,"slug":186,"hasResults":12,"nctId":187,"briefTitle":188,"officialTitle":189,"acronym":190,"eligibilityCriteria":191,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":192,"enrollmentInfo":193,"targetDuration":4,"studyType":24,"phases":195,"briefSummary":196,"conditions":197,"keywords":199,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":204,"startDateStruct":206,"completionDateStruct":208,"leadSponsor":210,"locationsCount":212},"100568999","phase-4-e-cigarette-cessation-in-adults-who-co-use-cannabis-100568999","NCT06688539","E-cigarette Cessation in Adults Who Co-use Cannabis","A Prospective Trial of Varenicline and Incentives for E-cigarette Cessation in Adults Who Co-use Cannabis","VapeCAT","Inclusion Criteria:\n\n* Between the ages of 18 and 40 years old\n* Use e-cigarettes daily or near daily in the past month\n* Must submit a positive instant-read urine cotinine test at screening (≥ 200 ng\u002Fml)\n* Be interested in quitting use of e-cigarettes\n* Must be willing to take varenicline for the standard 12-week course of treatment\n* Self-reported use of cannabis on at least 10 out of the past 30 days or must submit a positive qualitative urinary cannabinoid test at screening (\\> 50 ng\u002Fml)\n\nExclusion Criteria:\n\n* Any serious or unstable medical\u002Fpsychiatric disorder (including severe substance use disorders, other than cannabis or tobacco use disorders) in the past three months that may interfere with study performance\n* Use of cigarettes on 10+ days in the past 30\n* Currently pregnant or breastfeeding\n* Current use of medications with smoking cessation efficacy\n* Use of any medications that would interfere with varenicline","40 Years",{"count":194,"type":23},105,[59],"The purpose of this study is to better understand tobacco outcomes using a commonly prescribed stop smoking medication (varenicline) and financial incentives for adults who also use cannabis. Varenicline is not FDA approved for e-cigarette cessation, but is FDA approved for cigarette cessation. Investigators are also interested in how cannabis\u002Fmarijuana and tobacco interact during a tobacco quit attempt. All participants will receive e-cigarette cessation treatment for 12 weeks. To qualify, participants must be between the ages of 18-40 and use both e-cigarettes and cannabis. Participants do not need to be interested in quitting cannabis to qualify. This study is being conducted at three sites: the Medical University of South Carolina in Charleston, SC, Behavioral Health Services in Pickens, SC, and MUSC Lancaster in Lancaster, SC.",[29,198],"Tobacco Use Disorder",[200,201,202],"e-cigarettes","cannabis","treatment","2026-06-10",{"date":205,"type":38},"2026-06-12",{"date":207,"type":38},"2025-02-19",{"date":209,"type":23},"2027-06-01",{"name":211,"class":82},"Medical University of South Carolina",3,{"id":214,"slug":215,"hasResults":12,"nctId":216,"briefTitle":217,"officialTitle":218,"acronym":219,"eligibilityCriteria":220,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":221,"enrollmentInfo":222,"targetDuration":4,"studyType":24,"phases":224,"briefSummary":225,"conditions":226,"keywords":227,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":232,"startDateStruct":233,"completionDateStruct":235,"leadSponsor":237,"locationsCount":46},"100534478","young-adult-tobacconicotine-and-cannabis-co-use-100534478","NCT06239350","Young Adult Tobacco\u002FNicotine and Cannabis Co-use","The Impact of Cannabis and Tobacco\u002FNicotine Product Co-use in Young Adults: Prospective Cessation Evaluation and Substitution","YouthCAT","Inclusion Criteria:\n\n* Between the ages of 18 and 25 years old\n* Must use at least one nicotine or tobacco product (nicotine vaping and\u002For cigarettes) on at least 20 out of the past 30 days for at least the past 3 months\n* Must express interest in nicotine cessation (all products)\n* Must submit a positive instant-read, oral fluid cotinine sample prior to enrollment\n* Must report use of cannabis on at least 10 out of the past 30 days\n* Must submit a positive instant-read cannabinoid test prior to enrollment\n* Must be able to provide informed consent\n\nExclusion Criteria:\n\n* Any significant or acutely unstable medical, psychiatric, or substance use problem that would contraindicate research, interfere with safety, compromise data integrity, or preclude consistent study participation\n* Pregnant (self-report) or trying to become pregnant\n* Self-reported use of medications with smoking cessation efficacy\n* Immediate interest in cannabis cessation or treatment","25 Years",{"count":223,"type":23},350,[26],"The goal of this project is to better understand the relationship between tobacco\u002Fnicotine and cannabis using behavioral economics during a tobacco\u002Fnicotine quit attempt. All participants will receive tobacco\u002Fnicotine cessation treatment (smoking and\u002For vaping treatment) for 12 weeks. To qualify, participants must be between the ages of 18-25 and use tobacco products (smoke cigarettes and\u002For vape nicotine) and use cannabis (in any form). Participants do not need to be interested in quitting cannabis\u002Fmarijuana to qualify. This study is being conducted by the Medical University of South Carolina. All procedures are conducted remotely and there is no in-person visits are needed.",[198,29],[228,229,230,231],"tobacco","vaping","cessation","cannabis\u002Fmarijuana",{"date":205,"type":38},{"date":234,"type":38},"2024-05-13",{"date":236,"type":23},"2028-01-03",{"name":211,"class":82},{"id":239,"slug":240,"hasResults":12,"nctId":241,"briefTitle":242,"officialTitle":242,"acronym":4,"eligibilityCriteria":243,"healthyVolunteers":17,"sex":18,"minAge":244,"maxAge":4,"enrollmentInfo":245,"targetDuration":4,"studyType":24,"phases":247,"briefSummary":248,"conditions":249,"keywords":250,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":256,"lastUpdatePostDateStruct":257,"startDateStruct":259,"completionDateStruct":261,"leadSponsor":262,"locationsCount":46},"100634522","social-media-support-groups-for-adolescent-vaping-cessation-100634522","NCT07540780","Social Media Support Groups for Adolescent Vaping Cessation","Inclusion Criteria:\n\n1. English literacy\n2. Age between 13-21 years (group participants) or 18+ (coaches, peer mentors)\n3. Indicate they use social media \"most\" (\\>= 4) days per week (group participants)\n4. Have vaped at least once per week in the past 30 days (90 percent of participants) (group participants)\n5. Access to a computer or mobile phone with photo capability to verify abstinence from vaping (group participants)\n6. Indicate they are considering quitting or are interested in quitting with the next 6 months or within the next 30 days (group participants)\n7. Currently reside in California, Minnesota, Oklahoma, or South Carolina\n\nExclusion Criteria:\n\n1. No English literacy\n2. Age under 13 or over 21 (group participants) or under 18 (coaches, peer mentors)\n3. Insufficient social media use (3 or fewer days per week) (group participants)\n4. Have not vaped at least once per week in past 30 days (group participants)\n5. No access to computer or mobile phone with photo capability to verify abstinence from vaping (group participants)\n6. Not considering or interested in quitting vaping in the next 30 days or 6 months (group participants)\n7. Not a resident of California, Minnesota, Oklahoma, or South Carolina","13 Years",{"count":246,"type":23},60,[26],"The purpose of this study is to pilot test feasibility and acceptability of the Quit the Hit Toolkit, a social media-based nicotine vaping cessation program for adolescents and young adults, adapted for use in community settings.",[63,126,29],[251,252,253,229,254,255],"single arm","pilot","intervention","adolescent","young adult","2026-06-04",{"date":258,"type":38},"2026-06-08",{"date":260,"type":38},"2026-04-15",{"date":77,"type":23},{"name":263,"class":82},"University of California, San Francisco",{"id":265,"slug":4,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":266,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":267,"targetDuration":4,"studyType":24,"phases":268,"briefSummary":27,"conditions":269,"keywords":270,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":271,"lastUpdatePostDateStruct":272,"startDateStruct":274,"completionDateStruct":275,"leadSponsor":276,"locationsCount":46},"100487722","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\nAll Participants\n\n* Participants will be volunteers between the ages of 18-60 at the time of enrollment in the study (both sexes). Justification: Many neural processes change with age, and these changes could introduce unwanted variability in both behavioral and MRI signals.\n* Able and willing to provide written informed consent, which includes agreement to all Lifestyle Considerations at the time of study consent.\n\nNicotine Dependence Arm\n\n-Participants must smoke\u002Fvape a minimum of 4 times per week with a urine cotinine level corresponding to nicotine user status for the specific test being used (typically corresponding to a urine cotinine above about 200 ng\u002Fml) and have been smoking or vaping consistently for at least the past year (excluding quit attempts).\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\nAll Participants\n\n* Participants cannot meet DSM-5 criteria for lifetime and\u002For current psychotic disorders such as bipolar disorder, schizophrenia, schizoaffective disorder.\n* Participants cannot meet DSM-5 criteria for current substance use disorders other than nicotine and marijuana and cannot meet criteria for current moderate or severe alcohol use disorder.\n* Participants cannot have positive illicit drug and alcohol screen on each study visit other than for nicotine or marijuana.\n* Medications with the potential to depress CNS function will be assessed by the MAI, PI, or a physician's assistant and participants excluded as necessary.\n* Participants cannot have a history of major head trauma resulting in cognitive impairment, seizure, or other neurological disorders.\n* Participant cannot have any history of neurological disorders, including seizures, epilepsy, or cognitive impairment which may impact MRI metrics.\n* Participants cannot be pregnant or breastfeeding. Justification: The impact of suvorexant on the developing fetus and infant.\n* Individuals with severe hepatic impairment will be excluded\n* Participants cannot be obese as determined by a Body Mass Index (BMI) of greater than 35.\n* Participants cannot be using a CYP3A inhibitor\u002Finducer (metabolism by CYP3A is the major elimination pathway for suvorexant)\n* Participants cannot have any past or present significant cardiac disorders or cerebrovascular conditions such as palpitations, tachycardia, use of the cardiac medication Digoxin, arrhythmias, acute coronary syndrome, ischemic heart disease, or uncontrolled hypertension.\n* Participants cannot have narcolepsy.\n* Participants cannot self-report complex sleep behaviors such as sleep driving, preparing and eating food or making phone calls.\n* Participants with Major Depressive Disorder who are using medication must be stable on medication for 3 months.\n* Subjects with suicidal ideation where outpatient treatment is determined unsafe.\n* Subjects that cannot speak English. Justification: To include non-English speakers, we would have to translate the consent and other study documents and hire and train bilingual staff, which would require resources that we do not have and could not justify, given the small sample size for each experiment. Additionally, the data integrity of some of the cognitive tasks and standardized questionnaires used in this study would be compromised as they have only been validated in English. Most importantly, ongoing communication regarding safety procedures is necessary when participants are undergoing MRI procedures. The inability to effectively communicate MRI safety procedures in a language other than English could compromise the safety of non-English speaking participants.\n* Contraindication to MRI as determined by MRI Safety Screening form.\n\nNicotine Dependent Arm\n\n* Participants cannot self-report compromised respiratory function such as severe obstructive sleep apnea or severe chronic obstructive pulmonary disease.\n* Participants cannot meet DSM-5 criteria for moderate or severe ADHD.\n\nControl Arm\n\n* May not have used any nicotine product more than once per week in the past year. Must have an expired carbon monoxide level of less than or equal to 5 ppm.\n* Must not have a history of excessive substance use that may impact reward function, as evaluated by the PI, MAI, and\u002For designee.\n* Current pharmacological treatment for opioid use disorder (i.e., use of methadone)\n* May not have (or currently be treated\u002Fmedicated for) any diagnoses\u002Fconditions contraindicated for use of methylphenidate.\n* Participants may not have a diagnosis of moderate or severe ADHD (irrespective of medication use) or present with undiagnosed ADHD during screening.",{"count":22,"type":23},[26],[29],[31,32,33,29],"2026-05-27",{"date":273,"type":38},"2026-05-28",{"date":40,"type":38},{"date":42,"type":23},{"name":44,"class":45},{"id":278,"slug":279,"hasResults":12,"nctId":280,"briefTitle":281,"officialTitle":282,"acronym":4,"eligibilityCriteria":283,"healthyVolunteers":17,"sex":18,"minAge":90,"maxAge":284,"enrollmentInfo":285,"targetDuration":4,"studyType":24,"phases":286,"briefSummary":287,"conditions":288,"keywords":290,"overallStatus":295,"whyStopped":4,"lastUpdateSubmitDate":296,"lastUpdatePostDateStruct":297,"startDateStruct":299,"completionDateStruct":301,"leadSponsor":303,"locationsCount":46},"100623618","sex-differences-in-e-cigarette-perception-100623618","NCT07398976","Sex Differences in E-Cigarette Perception","Sex Differences in E-Cigarette Perception: Study 2","Inclusion Criteria:\n\n* Able to read\u002Fwrite in English\n* Current cigarette smoking\n* Prior e-cigarette exposure\n* Biochemically verified cigarette use\n* Not trying to quit tobacco use\n\nExclusion Criteria:\n\n* Significant medical concerns that would increase study risk\n* Use of psychoactive drugs unless prescribed and stable\n* Allergy to menthol or other e-liquid ingredients\n* Dislike of menthol\n* Pregnant, trying to get pregnant, breastfeeding","44 Years",{"count":246,"type":23},[26],"This study examines differences between males and females in the appeal and addiction potential of menthol flavored e-cigarettes with and without nicotine.",[29,289],"E-cigarette Use",[291,292,293,294,68,63],"Sex Differences","Females","E-cigarettes","Menthol","NOT_YET_RECRUITING","2026-05-18",{"date":298,"type":38},"2026-05-19",{"date":300,"type":23},"2026-06-15",{"date":302,"type":23},"2027-04-01",{"name":304,"class":82},"Yale University",{"id":306,"slug":307,"hasResults":12,"nctId":308,"briefTitle":309,"officialTitle":310,"acronym":311,"eligibilityCriteria":312,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":313,"targetDuration":4,"studyType":24,"phases":315,"briefSummary":317,"conditions":318,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":319,"lastUpdatePostDateStruct":320,"startDateStruct":322,"completionDateStruct":324,"leadSponsor":326,"locationsCount":46},"100520207","phase-3-community-based-smoking-cessation-treatment-for-adults-with-high-stress-sensitivity-100520207","NCT06053567","Community-based Smoking Cessation Treatment for Adults With High Stress Sensitivity.","Efficacy and Implementation of Exercise-based Smoking Cessation Treatment for Adults With High Anxiety Sensitivity.","STEP3","Inclusion Criteria:\n\n* Adult (age ≥ 18);\n* High Anxiety Sensitivity (≥5 on the Short Scale Anxiety Sensitivity Index \\[SSASI\\]);\n* Daily smoker, ≥5 cigarettes (including e-cigarettes, little cigars\u002Fcigarillos) for ≥1 year;\n* Motivated to quit smoking as evidenced by a score of ≥5 on a 0-10 Likert scale;\n* Body mass index \\\u003C 40;\n* Medical clearance to participate.\n* Located near a participating YMCA site (within 50 miles)\n\nExclusion Criteria:\n\n* Regular exercise defined as engaging in vigorous-intensity exercise for at least 75 minutes per week for the last 3 months\n* Receiving current intervention for smoking cessation.\n* Outstanding debt to the YMCA\n* Listed as a sex offender on the National Sex Offender Registry",{"count":314,"type":23},360,[316],"PHASE3","Anxiety sensitivity, reflecting the fear of bodily sensations, is a risk factor for the maintenance and relapse of smoking. This study is designed to address the question - is a smoking cessation intervention personalized to high anxiety sensitive smokers and adapted for implementation by the YMCA effective among racially\u002Fethnically diverse samples?",[29],"2026-05-12",{"date":321,"type":38},"2026-05-15",{"date":323,"type":38},"2023-12-27",{"date":325,"type":23},"2029-06-30",{"name":327,"class":82},"Jasper A. Smits",{"id":329,"slug":330,"hasResults":12,"nctId":331,"briefTitle":332,"officialTitle":332,"acronym":4,"eligibilityCriteria":333,"healthyVolunteers":17,"sex":18,"minAge":90,"maxAge":55,"enrollmentInfo":334,"targetDuration":4,"studyType":24,"phases":336,"briefSummary":338,"conditions":339,"keywords":341,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":319,"lastUpdatePostDateStruct":344,"startDateStruct":346,"completionDateStruct":348,"leadSponsor":350,"locationsCount":46},"100513189","phase-1-comparative-pharmacokinetics-and-pharmacodynamics-of-synthetic-nicotine-100513189","NCT05962229","Comparative Pharmacokinetics and Pharmacodynamics of Synthetic Nicotine","Inclusion Criteria:\n\n* Healthy on the basis of medical history and limited physical examination.\n* Current regular user of E-Cigarettes (≥ 15 days in the past 30 days)\n\nExclusion Criteria:\n\n* • Medications\n\n  * Use of medications that are inducers of nicotine metabolizing enzyme CYP2A6 (Example: rifampicin, carbamazepine, phenobarbital, and other anticonvulsant drugs).\n  * Use of sympatholytic medications for cardiovascular conditions including hypertension (Example: beta and alpha-blockers).\n  * Concurrent use of nicotine-containing medications (Example: nicotine patch, lozenge, gum).\n  * Any stimulant medications (example: Adderall) generally given for ADHD treatment.\n\n    • Pregnancy\n  * Pregnancy (self-reported and urine pregnancy test)\n  * Breastfeeding (determined by self-report)\n  * Women of childbearing potential must be using an acceptable method of contraception\n\n    * Inability to read and write in English\n    * A known propylene glycol\u002Fvegetable glycerin allergy\n    * Uncomfortable with getting blood drawn",{"count":335,"type":23},18,[337],"PHASE1","In a crossover study, experienced electronic cigarette users will vape 3 different forms of nicotine: natural (derived from tobacco), synthetic, or a 50:50 mixture of both natural and synthetic. The investigators will compare nicotine metabolism, cardiovascular effects, patterns of self-administration, and participants' feelings of craving\u002Fwithdrawal and enjoyment.",[29,340],"Nicotine Vaping",[342,343,63,293],"Nicotine Pharmacokinetics","Nicotine Pharmacodynamics",{"date":345,"type":38},"2026-05-14",{"date":347,"type":38},"2024-12-06",{"date":349,"type":23},"2027-05",{"name":263,"class":82},{"id":352,"slug":353,"hasResults":12,"nctId":354,"briefTitle":355,"officialTitle":356,"acronym":357,"eligibilityCriteria":358,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":359,"targetDuration":4,"studyType":24,"phases":361,"briefSummary":362,"conditions":363,"keywords":365,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":370,"startDateStruct":372,"completionDateStruct":374,"leadSponsor":376,"locationsCount":46},"100636653","tubsis-20---tobacco-use-behavioral-support-and-intervention-system-100636653","NCT07568483","TUBSIS 2.0 - Tobacco Use Behavioral Support and Intervention System","Effectiveness of an Internet-based, Self-help, Asynchronized Behavioral Therapy With Mindfulness Approach for Adults With Tobacco Smoking or Vaping to Support Adults in Reducing Tobacco Smoking and Vaping in Switzerland and Türkiye","TUBSIS_2_0","Inclusion Criteria:\n\n* Age: 18 years or older\n* Smoking status:\n\nSmoked on ≥1 day in the past 30 days, and\u002For Smoked at least 100 cigarettes in lifetime\n\n* Internet access: Stable internet connection and access to a smartphone, tablet, or computer during interaction of the TUBSIS 2.0 web-based platform.\n* Language: Sufficient reading and listening comprehension in the study language (German, English or Turkish)\n* Contact: Valid email address and phone number (optional) for study communication, reminders and incentive payments\n* Consent: Provided electronic informed consent on TUBSIS 2.0 web-based platform which is developed and administrated by ISGF.\n* Study procedures: Agreement to randomization (intervention or control) and completion of study assessments at four time points (baseline, mid-intervention, post-intervention and 8-week follow-up)\n\nExclusion Criteria:\n\n* Individuals who do not meet the inclusion criteria are excluded.",{"count":360,"type":23},406,[26],"Background:\n\nTobacco smoking and vaping remains public health concern, with many adults continuing to experience difficulties accessing appropriate support for smoking cessation in Switzerland and Türkiye. Structural barriers, including stigma related to attempting to quit, limited financial and time resources, low awareness of the health risks associated with tobacco smoking- and vaping-reduce engagement with traditional services. TUBSIS 2.0 aims to address these access inequities by providing a fully remote, anonymous and free internet-based program tailored to diverse adult populations in both countries.\n\nObjectives:\n\nThe \"TUBSIS 2.0: An Adaptation Study of Tobacco Addiction Support Programme - TUBSIS for Tobacco Users in Switzerland and Türkiye\" project aims to support readiness to reduce or quit tobacco smoking\u002Fvaping, improve well-being and self-compassion and strengthen health-related behaviors. The intervention targets German-, English-, and Turkish-speaking adults and includes mindfulness-based strategies for quitting or reducing tobacco smoking and vaping. Motivation to cease tobacco smoking\u002Fvaping varies considerably across the lifespan. Younger individuals may perceive smoking\u002Fvaping cessation as unnecessary, often due to limited awareness of long-term health risks or a sense of invulnerability. In later adulthood, although addiction tends to be more deeply established, many individuals hesitate to attempt cessation because of concerns about the psychological and behavioral challenges associated with the process. It is therefore essential to provide individuals with support that helps them understand the cessation process, prepare for the challenges that can be expected and identify strategies that align with their psychological needs. Such strategies may include stress management and self-compassion practices that can be utilized before, during and after cessation attempts. TUBSIS 2.0 offers structured and accessible guidance to support this preparation by providing a clear, evidence-based pathway for individuals at different stages of readiness to change.\n\nMethods:\n\nTUBSIS 2.0 is a web-based, individual and asynchronous program consisting of eight modules delivered over four weeks. A total of 406 participants will be recruited and randomly assigned to either the intervention or control group. Data are collected anonymously at four measurement points (baseline, mid-term, post-term and 8-week follow-up) from participants. The program focuses on supporting participants' reducing or quitting tobacco smoking or vaping; to increase their readiness for smoking\u002Fvaping cessation, mental well-being, self-compassion and stress management with mindfulness strategies.\n\nWithin the Health Action Process Approach (HAPA), the process of behaviour change is conceptualised as a dynamic, non-linear process that progresses through motivational and volitional phases. TUBSIS 2.0 has been adapted to reflect this structure by integrating phase-specific components. These components include modules that enhance risk awareness and outcome expectancies, planning and self-regulation tools to support action initiation and mindfulness-based strategies that are embedded throughout all phases to strengthen self-efficacy and coping. By addressing these shifting needs across the change process, the programme provides a responsive and theory-driven pathway for reducing\u002Fquitting tobacco smoking or vaping.\n\nRelevance:\n\nTUBSIS 2.0 is highly relevant to public health priorities, as it provides a cost-effective, scalable and environmentally sustainable intervention that eliminates barriers commonly associated with traditional cessation services. By requiring no travel, printed materials or in-person appointments, the programme offers equitable access to adults across all age groups, genders and diverse migrant communities in Switzerland and Türkiye. Its multilingual and culturally adapted structure addresses significant service gaps for populations that are underserved or hesitant to seek conventional support. By reducing tobacco smoking- or vaping-related harm and facilitating early behavioural change, TUBSIS 2.0 has the potential to decrease long-term healthcare costs while expanding access to evidence-based digital prevention tools.",[198,29,63,364],"Smoking Tobacco",[366,229,367,368,369],"smoking tobacco","web-based intervention","mindfulness","Health Action Process Approach",{"date":371,"type":38},"2026-05-05",{"date":373,"type":38},"2025-11-15",{"date":375,"type":23},"2026-08-31",{"name":377,"class":82},"University of Zurich",{"id":379,"slug":380,"hasResults":12,"nctId":381,"briefTitle":382,"officialTitle":383,"acronym":384,"eligibilityCriteria":385,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":386,"targetDuration":4,"studyType":24,"phases":388,"briefSummary":390,"conditions":391,"keywords":392,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":395,"lastUpdatePostDateStruct":396,"startDateStruct":398,"completionDateStruct":400,"leadSponsor":402,"locationsCount":46},"100593496","early-phase-1-smart-olfaction-app-to-reduce-relapse-100593496","NCT07007195","Smart Olfaction App to Reduce Relapse","An Innovative Digitally-Delivered Olfactory Method for Reducing Cigarette Cravings and Supporting Smoking Cessation","SOARR","Inclusion Criteria:\n\n* At least 18 years of age\n* Ability to read, understand and speak English\n* Currently smoke at least 5 cigarettes daily for one year or longer\n* Do not currently smoke marijuana or currently smoke marijuana but willing to not smoke during the duration of the study\n* Did not use electronic cigarette or vaping device in the past 90 days\n* Have an active smartphone that is Apple or Android based\n* Have phone service including a data plan\n* Interested in downloading the study app onto their personal phone\n* Motivated to quit smoking\n* English literacy of 7th grade or higher, as indicated by a score of ≥ 4 on the Rapid Estimate of Adult Literacy in Medicine-Short Form (REALM-SF)\n* Biochemical verification of smoking status\n* Proof of smoking status at enrollment via photo of cigarettes\n* Presents a photo ID that matches the information on screener survey\n* Willing and able to complete study procedures\n* Willing to use NRT and quit smoking for 14 days (Phase I) or willing to use NRT and quit smoking for 13 weeks (Phase II)\n\nExclusion Criteria:\n\n* Olfactory dysfunction including inability to smell, a very weak or distorted sense of smell, or sensitivity to odors\n* Report any allergies or negative reactions to odors\u002Ffragranced products\n* Being pregnant, breastfeeding, or planning to become pregnant within the next month\n* Report hypertension that is not under control\n* Have had a heart attack within the past two weeks\n* Those who participated in Phase I will not be eligible to participate in Phase II\n* Have a smartphone that is not compatible with the Insight mHealth platform\n* Report using electronic cigarette or vaping device in the past 90 days\n* Cognitive impairment, verified via a score of ≥ 8 on the Six-Item Cognitive Impairment Test (6-CIT)",{"count":387,"type":23},132,[389],"EARLY_PHASE1","The proposed project aims to refine and test a novel biobehavioral smoking cessation intervention that integrates the strategic application of olfactory stimulation to reduce cigarette craving with an established smartphone-based smoking cessation application. The specific aims of this study are: (1) refine the design and methodology of our olfactory stimulation delivery system (OSDS) and (2) compare, in a pilot randomized controlled trial (RCT), the effects of a smartphone based app for smoking cessation (Smart-T) with and without the OSDS on smoking cessation outcomes.",[29],[393,64,394,29],"Substance-Related Disorders","Smartphone-Based Smoking Cessation","2026-04-29",{"date":397,"type":38},"2026-05-01",{"date":399,"type":38},"2026-04-22",{"date":401,"type":23},"2027-08-31",{"name":403,"class":82},"University of Houston",{"id":405,"slug":406,"hasResults":12,"nctId":407,"briefTitle":408,"officialTitle":409,"acronym":4,"eligibilityCriteria":410,"healthyVolunteers":17,"sex":18,"minAge":90,"maxAge":20,"enrollmentInfo":411,"targetDuration":4,"studyType":24,"phases":413,"briefSummary":414,"conditions":415,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":417,"lastUpdatePostDateStruct":418,"startDateStruct":420,"completionDateStruct":422,"leadSponsor":424,"locationsCount":46},"100484386","phase-4-beta-adrenergic-modulation-of-drug-cue-reactivity-100484386","NCT05587361","Beta-Adrenergic Modulation of Drug Cue Reactivity","Beta-Adrenergic Modulation of Drug Cue Reactivity: Neural and Behavioral Mechanisms","Inclusion Criteria:\n\n1. Generally healthy\n2. Age 21-60\n3. Right-handed using a three-item scale\n4. Daily smoker of ≥ 5 cigarettes\u002Fday delivering 0.5 mg nicotine (FTC)\n5. Smoking regularly for ≥ 1 year, with stable smoking for the past 6 months\n6. Afternoon expired Carbon Monoxide (CO) concentration ≥ 6 ppm and\u002For morning urinary cotinine \\>100 ng\u002Fml\n7. Must identity at least 4 different smoking locations used in a typical week\n8. Able to read and understand English\n\nExclusion Criteria:\n\n1. Inability to attend all required sessions\n2. Significant health problems that would preclude active participation\n3. Presence of conditions that would make MRI unsafe (e.g. pacemaker) or (e.g. weight and body shape)\n4. Current use of psychoactive medications\u002Fdrugs as indicated by self-report or urine screen\n5. Positive breath alcohol concentration\n6. Pregnant, breastfeeding, or planning to become pregnant during the course of the study (females)\n7. Problems with vision that cannot be corrected with contacts or glasses\n8. Current regular use of smokeless tobacco, smoking cessation medications, or other nicotine containing products (e.g. electronic cigarettes)\n9. Current use of beta-adrenergic medications (e.g. beta-blockers) or other blood pressure medications\n10. Systolic blood pressure \\\u003C 90 mmHg or diastolic blood pressure \\\u003C 60 mmHg (sitting or standing)\n11. Abnormal EKG\n12. Presence of severe anemia\n13. Presence of electrolyte imbalance that could impact blood pressure\n14. Presence of any other contraindications for propranolol or nicotine patch (e.g. cardiovascular disease, bronchial asthma, prior allergic reactions, diabetes)",{"count":412,"type":23},80,[59],"This study is designed to investigate the effects of a beta-adrenergic antagonist (Propranolol; 40 mg IR) and nicotine patch (14 mg) administered alone and in combination on neurobiological and behavioral responses to smoking cues in ongoing cigarette smokers. This is a basic experimental study in humans and participants will not take these medications for an extended period or make a cessation attempt as part of their involvement in this research project.",[198,29,416],"Cigarette Smoking","2026-04-27",{"date":419,"type":38},"2026-04-28",{"date":421,"type":38},"2024-11-26",{"date":423,"type":23},"2027-03-31",{"name":425,"class":82},"University of Oklahoma",{"id":427,"slug":428,"hasResults":12,"nctId":429,"briefTitle":430,"officialTitle":431,"acronym":4,"eligibilityCriteria":432,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":55,"enrollmentInfo":433,"targetDuration":4,"studyType":24,"phases":434,"briefSummary":435,"conditions":436,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":440,"lastUpdatePostDateStruct":441,"startDateStruct":443,"completionDateStruct":445,"leadSponsor":446,"locationsCount":46},"100628840","auricular-stimulation-for-nicotine-withdrawal-in-psychiatric-inpatients-100628840","NCT07466875","Auricular Stimulation for Nicotine Withdrawal in Psychiatric Inpatients","The Efficacy of Auricular Acupressure Combined With Nicotine Replacement Therapy on Nicotine Craving, Withdrawal Symptoms and Anxiety Levels in Psychiatric Inpatients: A Pilot Randomized Controlled Trial","Inclusion Criteria:\n\n* Psychiatric inpatients aged 18 to 65 years.\n* Diagnosed with a mental disorder according to ICD-10-CM criteria.\n* History of daily smoking within the past six months (Fagerström Test for Nicotine Dependence \\[FTND\\] score ≥ 2).\n* Experiencing nicotine withdrawal symptoms due to mandatory smoking cessation upon admission (Minnesota Tobacco Withdrawal Scale \\[MNWS\\] baseline score ≥ 5).\n* Agree to and comply with the standard-of-care Nicotine Replacement Therapy (NRT) provided by the hospital.\n* Capable of understanding the study procedures and providing written informed consent\n\nExclusion Criteria:\n\n* Presence of severe skin infection, open wounds, or lesions on the auricle (outer ear).\n* Severe coagulation disorders or currently taking high-dose anticoagulants (due to potential risk of bleeding or irritation).\n* Pregnant or breastfeeding women.\n* Significant language barriers or cognitive impairment that prevents completion of assessment scales or adherence to study protocols.\n* History of receiving auricular therapy for smoking cessation within the past three months.",{"count":246,"type":23},[26],"The goal of this clinical trial is to evaluate the feasibility and preliminary effectiveness of auricular acupressure (ear seeds) combined with nicotine replacement therapy (NRT) in psychiatric inpatients (both male and female, aged 18-65) who are forced to abstain from smoking due to the smoke-free environment of the inpatient ward. The main questions it aims to answer are:\n\n* Does auricular acupressure significantly reduce the severity of nicotine withdrawal symptoms compared to standard care?\n* Can auricular acupressure effectively lower nicotine craving and anxiety levels in patients during their mandatory abstinence? Researchers will compare the experimental group (NRT plus active auricular acupressure) to a control group (NRT plus sham auricular acupressure) to see if the addition of ear point stimulation provides better relief for withdrawal distress.\n\nParticipants will:\n\n* Receive standard nicotine replacement therapy (NRT) as prescribed by their physician.\n* Be randomly assigned to receive either Vaccaria segetalis seeds or sham materials on specific ear acupuncture points.\n* Be instructed to press the beads 3 times daily to stimulate the points for a period of 4 weeks.\n* Complete standardized assessments (MNWS, HAMA, and craving scales) at baseline and multiple time points during the intervention.",[29,437,198,438,439],"Nicotine Withdrawal","Anxiety","Mental Disorders","2026-04-06",{"date":442,"type":38},"2026-04-13",{"date":444,"type":38},"2026-03-23",{"date":42,"type":23},{"name":447,"class":82},"Chiao-Chiao Liao",{"id":449,"slug":450,"hasResults":12,"nctId":451,"briefTitle":452,"officialTitle":453,"acronym":4,"eligibilityCriteria":454,"healthyVolunteers":12,"sex":18,"minAge":90,"maxAge":4,"enrollmentInfo":455,"targetDuration":4,"studyType":24,"phases":457,"briefSummary":458,"conditions":459,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":461,"lastUpdatePostDateStruct":462,"startDateStruct":464,"completionDateStruct":466,"leadSponsor":468,"locationsCount":46},"100522026","effects-of-e-cigs-vs-pouches-on-cigarette-smoking-and-addiction-100522026","NCT06077240","Effects of E-cigs vs Pouches on Cigarette Smoking and Addiction","Evaluating The Effects Of E-cigarettes Versus Oral Nicotine Pouches and Product Constituents (Menthol Flavor, Nicotine Concentration) On Adult Cigarette Smoking and Addiction","Inclusion Criteria:\n\n* 21+ years old\n* English literate\n* Currently smoking cigarettes, biochemically confirmed\n\nExclusion Criteria:\n\n* Currently using smoking cessation pharmacotherapies (NRT, bupropion, varenicline)\n* Currently pregnant or breastfeeding\n* Significant current medical or psychiatric condition\n* Known hypersensitivity to propylene glycol",{"count":456,"type":23},256,[26],"The study will recruit an anticipated 256 adults who currently smoke cigarettes and report a willingness to try switching to alternative, non-combustible products. Participants will be randomized to receive either e-cigarettes or nicotine pouches for a duration of 4 weeks and to 1 of 4 possible regulatory scenarios within products where flavor availability is either menthol and tobacco\u002Funflavored available or tobacco\u002Funflavored only available, and nicotine concentration is either higher (5% e-cig, 6mg pouch) or lower (2.4% e-cig, 3mg pouch). Participants will return for bi-weekly research visits (in person or remote videocall) to complete measures for study aims. Participants will complete a final follow-up at Week 6 to assess maintenance of cigarette reduction and willingness to continue using products once they are no longer provided. The investigators expect to observe which products and constituents lead to greater smoking reduction.",[67,460,29],"Smoking Behaviors","2026-03-17",{"date":463,"type":38},"2026-03-19",{"date":465,"type":38},"2024-08-20",{"date":467,"type":23},"2028-04-01",{"name":304,"class":82},{"id":470,"slug":471,"hasResults":12,"nctId":472,"briefTitle":473,"officialTitle":474,"acronym":475,"eligibilityCriteria":476,"healthyVolunteers":12,"sex":477,"minAge":19,"maxAge":192,"enrollmentInfo":478,"targetDuration":4,"studyType":24,"phases":480,"briefSummary":481,"conditions":482,"keywords":486,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":461,"lastUpdatePostDateStruct":495,"startDateStruct":496,"completionDateStruct":498,"leadSponsor":500,"locationsCount":46},"100478851","phase-4-smoking-cessation-and-menstrual-cycle-phase-100478851","NCT05515354","Smoking Cessation and Menstrual Cycle Phase","Coordinating Smoking Cessation Treatment With Menstrual Cycle Phase to Improve Quit Outcomes: A Randomized Controlled Trial","MC-NRT","Inclusion Criteria:\n\n* Must provide informed consent following the CAMH REDCap e-consent framework and procedures;\n* Stated willingness to comply with all study procedures;\n* Naturally cycling individuals with regular MCs (defined as length ranging 21 to 35 days over past 6 months);\n* Daily smoker of ≥5 cigarettes per day (CPD) over past 6 months;\n* Intention to quit smoking within the next 30 days and willing to make a quit attempt on their assigned TQD;\n* Interested in using, and able to use, nicotine patches and gum or lozenge as a smoking cessation aid;\n* Willing to provide a valid e-mail address to be used for study communications and to complete online questionnaires.\n\nExclusion Criteria:\n\n* Current use of progesterone, estrogen, testosterone, or fertility treatment;\n* Current use of nicotine replacement therapy or other smoking cessation medications (e.g., varenicline, bupropion);\n* Use of hormonal contraceptives in the past 6 months (e.g., pill, patch, hormonal intrauterine device \\[IUD\\], ring);\n* Pregnancy, or trying to become pregnant in the next 2-3 months;\n* Known hypersensitivity or allergies to any of the components of the nicotine patch;\n* Daily or almost daily use of cannabis in the past 6 months;\n* Daily or almost daily use of tobacco or nicotine products other than cigarettes (e.g., smokeless tobacco, heat-not-burn products, e-cigarettes) in the past 6 months;\n* Polycystic ovary syndrome diagnosis;\n* Unstable psychiatric condition (including substance use disorder) which would compromise study compliance;\n* Life threatening arrhythmias or severe\u002Fworsening angina pectoris;\n* Myocardial infarction or cerebral vascular accident in the past 2 weeks; or\n* Diagnosed with a terminal illness.","FEMALE",{"count":479,"type":23},1200,[59],"Tobacco use is a risk factor for at least 20 types of cancer and remains the leading preventable cause of cancer in Canada. Smoking cessation is an important cancer prevention strategy for the close to 2 million Canadian women who currently smoke. However, findings from controlled trials and real-world clinical settings indicate that women have greater difficulty achieving abstinence following a quit attempt than men. There is some evidence that hormonal levels and fluctuations throughout the menstrual cycle (MC) may contribute to the greater difficulty women experience when trying to quit smoking. In this study, the start of a quit attempt using nicotine replacement therapy (NRT) will be targeted to specific phases of MC. It was hypothesized that starting a quit attempt during the first half of MC (follicular phase) will result in increased quit success compared to starting during the second half of MC (luteal phase) or the usual practice of not targeting quit start date to MC phase.",[29,483,64,484,485],"Tobacco Smoking","Nicotine Use Disorder","Substance Use Disorders",[487,488,489,490,491,492,493,494],"Menstrual Cycle","Ovarian Hormones","Smoking Cessation Treatment","Nicotine Replacement Therapy","Cancer Prevention","Randomized Controlled Trial","Estrogen","Progesterone",{"date":463,"type":38},{"date":497,"type":38},"2022-11-30",{"date":499,"type":23},"2026-12-31",{"name":501,"class":82},"Centre for Addiction and Mental Health",{"id":503,"slug":4,"hasResults":12,"nctId":504,"briefTitle":505,"officialTitle":505,"acronym":4,"eligibilityCriteria":506,"healthyVolunteers":17,"sex":18,"minAge":90,"maxAge":4,"enrollmentInfo":507,"targetDuration":4,"studyType":24,"phases":508,"briefSummary":509,"conditions":510,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":512,"lastUpdatePostDateStruct":513,"startDateStruct":515,"completionDateStruct":517,"leadSponsor":519,"locationsCount":46},"100538816","NCT06295757","Effects of Relighting on Smoke Toxicant Deliveries and Subjective Smoking Measures","Inclusion Criteria:\n\n* Smoking at least 10 cigarettes\u002Fday for at least 1 year (confirmed by CO \\> 8 ppm or NicAlert test of 6)\n* Engaging in relighting for at least half of their CPD\n* No smoking quit attempts in the past month nor intentions to quit in the next month\n* Stable medical or psychiatric conditions with systolic blood pressure \\\u003C 160, diastolic blood pressure \\\u003C 100 and heart rate \\\u003C 105 bpm\n\nExclusion Criteria:\n\n* Participant with current or recent alcohol or drug abuse problems, use of substances of abuse (other than marijuana due to high prevalence of co-use) within the past month\n* Currently trying or planning to quit smoking in the next month\n* Planning to become pregnant, pregnant or breastfeeding. Pregnancy exclusion will be confirmed through a urine test.",{"count":57,"type":23},[26],"Characterize effects of relighting on smoke toxicant deliveries and subjective smoking measures. This will be a within-subject comparison in a single experimental group of 30 smokers who report engaging in relighting behaviors. We will assess smoking intensity for relit and non-relit (i.e., smoked continuously without relighting) cigarettes in the natural environment and will conduct in-clinic measurements of smoking topography and subjective responses for relit and non-relit cigarettes. Information on relighting patterns and smoking topography collected from each participant will be used to compare machine-measured smoke yields of key harmful constituents when their usual cigarettes are smoked with and without relighting. Hypothesis: Relit cigarettes will produce higher levels of toxicants than non-relit cigarettes.",[511,416,29],"Tobacco Use","2026-02-02",{"date":514,"type":38},"2026-02-04",{"date":516,"type":38},"2024-10-12",{"date":518,"type":23},"2028-01-01",{"name":520,"class":82},"Masonic Cancer Center, University of Minnesota",{"id":522,"slug":523,"hasResults":12,"nctId":524,"briefTitle":525,"officialTitle":525,"acronym":4,"eligibilityCriteria":526,"healthyVolunteers":12,"sex":527,"minAge":19,"maxAge":528,"enrollmentInfo":529,"targetDuration":4,"studyType":24,"phases":530,"briefSummary":531,"conditions":532,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":535,"lastUpdatePostDateStruct":536,"startDateStruct":538,"completionDateStruct":540,"leadSponsor":541,"locationsCount":46},"100612180","effect-of-perioperative-high-dose-transdermal-nicotine-patch-on-pain-sensitivity-among-male-abstinent-tobacco-smokers-undergoing-thoracic-surgery-a-randomized-controlled-pilot-study-100612180","NCT07250230","Effect of Perioperative High-dose Transdermal Nicotine Patch on Pain Sensitivity Among Male Abstinent Tobacco Smokers Undergoing Thoracic Surgery: A Randomized Controlled Pilot Study","Inclusion Criteria:\n\n1. Male, aged 18-75 years, with a body mass index (BMI) of 18-28 kg\u002Fm2 Between;\n2. Thoracoscopic lobectomy\u002Fsegmental\u002Fwedge resection under general anesthesia;\n3. American Society of Anesthesiologists (ASA) classifications I-III Level;\n4. Regular smoking for more than 2 years, smoking more than 10 cigarettes per day in the past 6 months, and not successfully quitting smoking within 1 month (after admission, the doctor and nurse informed the smoking cessation plan to intervene before starting to stop smoking or 1 ≤ cigarette count ≤ 10 cigarettes\u002Fday in the past month), FTND score ≥ 2;\n5. No severe respiratory diseases, no serious cardiovascular and cerebrovascular diseases (hypertension is treated with SBP ≤ 160mmHg, DBP ≤ 90mmHg after systemic treatment);\n6. Obtain informed consent.\n\nExclusion Criteria:\n\n1. Those who have a history of alcoholism, long-term use of sedatives or analgesics;\n2. Patients with psychiatric and nervous system diseases (such as Parkinson's, depression, schizophrenia) and severe audio-visual dysfunction before surgery;\n3. Preoperative systolic blood pressure \\> 180mmHg or diastolic blood pressure \\> 110mmHg;\n4. Patients who were converted to thoracotomy during thoracoscopic surgery\n5. Patients who are transferred to the intensive care unit after surgery;\n6. Patients who refuse to use analgesic pump treatment\u002Fdo not configure the analgesic pump according to regulations;\n7. Patients who have self-removed patches\u002Fshort hospital stay resulting in a postoperative observation time of \\\u003C 48 hours","MALE","75 Years",{"count":412,"type":23},[26],"Globally, approximately 230 million adults undergo surgical procedures each year, with around 30% of patients maintaining smoking habits prior to surgery. Extensive clinical research has confirmed that tobacco exposure is a significant independent risk factor for perioperative complications. Epidemiological data indicate that long-term smokers experience a significantly higher all-cause mortality rate during hospitalization, approximately 20% greater than non-smokers, while the incidence of postoperative complications is 40% higher. Consequently, international guidelines universally recommend the establishment of standardized preoperative smoking cessation programs for surgical patients. Nicotine withdrawal, a typical clinical manifestation during smoking cessation, involves symptoms across multiple systems: neuropsychiatric symptoms such as mood depression, sleep disturbances, and irritability; autonomic dysfunction leading to postural dizziness and bradycardia; and metabolic dysregulation resulting in increased appetite and weight gain. Notably, these withdrawal symptoms exhibit a significant time-dependent pattern, typically peaking 24-72 hours after cessation. Multicenter studies have demonstrated that tobacco-dependent patients experience an average increase of IV Abstract 35-45% in opioid consumption within 24 hours postoperatively, with the duration of analgesic requirements extended by approximately 25%. However, some patients suffer from severe adverse reactions to opioids (e.g., nausea, vomiting, confusion), making the use of adjuvant medications for multimodal analgesia and optimized pain management particularly crucial. By the late 20th century, the analgesic properties of nicotine, a primary component of tobacco, were systematically studied and applied in clinical practice.",[29,533,534],"Thoracic Diseases","Analgesia","2026-01-20",{"date":537,"type":38},"2026-01-22",{"date":539,"type":38},"2025-11-30",{"date":499,"type":23},{"name":542,"class":82},"Henan Provincial People's Hospital",{"id":544,"slug":4,"hasResults":12,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":545,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":55,"enrollmentInfo":546,"targetDuration":4,"studyType":24,"phases":547,"briefSummary":548,"conditions":549,"keywords":550,"overallStatus":295,"whyStopped":4,"lastUpdateSubmitDate":551,"lastUpdatePostDateStruct":552,"startDateStruct":554,"completionDateStruct":556,"leadSponsor":558,"locationsCount":46},"100604157","Inclusion Criteria:\n\n* Age ≥ 18 and ≤65;\n* The ability to give written, informed consent;\n* Fluency in English;\n* Reported interest in quitting nicotine vaping or smoking within the next month;\n* Nicotine dependence, as defined by a score of ≥4 on the 10-question E-cigarette Dependence Inventory (ECDI) or Fagerström Test for Nicotine Dependence (FTND);\n* Smoke or vape nicotine daily for at least the past 90 days, as confirmed by self-report and timeline follow-back methods;\n* Saliva cotinine \\>30ng\u002FmL;\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding;\n* Use of smoking cessation pharmacotherapy in the past month;\n* Unwilling to abstain during the study from using smoking cessation aids other than those provided by the study;\n* Prior adverse drug reaction to varenicline;\n* Receiving or planning to receive other TMS treatments or investigational drugs during course of participation\n* Contraindications to TMS (including seizures, metallic implants, severe existing tinnitus, etc.);\n* Contraindications to MRI (including presence of a cardiac pacemaker or pacemaker wires, metallic particles in the body, vascular clips in the head or previous neurosurgery, prosthetic heart valves, claustrophobia);\n* Inpatient psychiatric hospitalization or suicide attempts in the past six months, or recent active suicidal ideation or suicidal behavior identified at enrollment or baseline visits;\n* History of seizures and\u002For history of TBI subtypes associated with elevated seizure risk (e.g. penetrating injury and intraparenchymal hemorrhage)\n* History of unstable neurological illness or major medical illness, such as epilepsy or renal impairment, in the past six months, unless clearly resolved;\n* In the opinion of the investigators, evidence of active problem substance use severe enough to compromise ability to safely participate;\n* In the opinion of the investigators, unable to safely participate in this study and\u002For provide reliable data (e.g., claustrophobia, unable to tolerate TMS or MRI procedures, etc.).",{"count":57,"type":23},[59],"The goal of this clinical trial is to learn if a combination of varenicline and accelerated Transcranial Magnetic Stimulation (aTMS) works to help adults quit using nicotine products. Researchers will compare varenicline + active aTMS to varenicline + sham (inactive) aTMS to see the effect of aTMS on reaching abstinence. The main question it aims to answer is: Does receiving active aTMS + varenicline lead to higher abstinence rates and lower nicotine craving?\n\nParticipants will be asked to:\n\n* Complete 2 brain MRI scans\n* Take varenicline every day for 12 weeks\n* Quit using nicotine products at the end of the second week of varenicline\n* Complete 5 consecutive days (Monday-Friday, uninterrupted) of TMS treatments\n* Complete 12 brief, weekly follow-up visits\n* Complete a brief daily survey each day that they take the study drug",[29,62,63,64,65],[63,67,68,69,70,71,62,72],"2026-01-14",{"date":553,"type":38},"2026-01-16",{"date":555,"type":23},"2026-03-15",{"date":557,"type":23},"2027-12-01",{"name":81,"class":82},{"id":560,"slug":561,"hasResults":12,"nctId":562,"briefTitle":563,"officialTitle":564,"acronym":565,"eligibilityCriteria":566,"healthyVolunteers":17,"sex":18,"minAge":90,"maxAge":4,"enrollmentInfo":567,"targetDuration":4,"studyType":24,"phases":569,"briefSummary":570,"conditions":571,"keywords":572,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":573,"lastUpdatePostDateStruct":574,"startDateStruct":576,"completionDateStruct":578,"leadSponsor":580,"locationsCount":46},"100568251","evaluation-of-low-and-high-nicotine-tobacco-free-nicotine-pouches-100568251","NCT06678789","Evaluation of Low and High Nicotine Tobacco Free Nicotine Pouches","Evaluation of Low and High Nicotine Tobacco Free Nicotine Pouches as a Harm Reducing Substitute for Combustible Cigarettes - (Pack2Pouch)","Pack2Pouch","Inclusion Criteria:\n\n* Age 21+\n* current cigarette smoking (25+ days per previous month, 5 or more cigarettes\u002Fday, for greater than 1yr, greater than 100 lifetime cigarettes)\n* have not used TNFPs more than 5 times during their lifetime\n* willing and able to attend 2 in-person visits in Charleston (to assess biomarkers)\n* have internet access\n\nExclusion Criteria:\n\n* Lack of proficiency in English.\n* Use of other combustible tobacco products (i.e., cigars, cigarillos, hookahs) and\u002For other non-combusted nicotine\u002Ftobacco products (i.e., e-cigarettes, smokeless tobacco) in the past 30 days.\n* Current use of smoking cessation medications (i.e., varenicline, bupropion, nicotine replacement therapy).\n* Use of marijuana within the past month, and unwillingness to abstain from marijuana during course of study.\n* Medical conditions contraindicated to NRT use (including pregnancy, breastfeeding, and nursing, past month myocardial infarction, current untreated cardiac arrhythmia, current severe angina, current uncontrolled severe vascular disease).",{"count":568,"type":23},50,[26],"Tobacco-free oral nicotine pouches (such as Zyn brand) are a less harmful alternative to cigarette smoking. Pouches, however, contain nicotine, and addictive substance that is not risk-free. The present study is evaluating how well nicotine pouches, at different nicotine levels, help people switch away from smoking cigarettes. People who smoke cigarettes will be asked to answer questions about their tobacco product use and provide breath samples and cheek swab samples at an in-person visit to MUSC Charleston. Participants will then be provided with a 28-day supply of nicotine pouches, and will be asked to switch from smoking to pouches over the course of 4 weeks. Finally, participants will complete a final visit at MUSC, and will answer more questions about their tobacco use 1-month later.",[416,29,64],[67],"2025-12-17",{"date":575,"type":38},"2025-12-18",{"date":577,"type":38},"2025-02-14",{"date":579,"type":23},"2027-02-28",{"name":211,"class":82},{"id":582,"slug":583,"hasResults":12,"nctId":584,"briefTitle":585,"officialTitle":586,"acronym":4,"eligibilityCriteria":587,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":588,"targetDuration":4,"studyType":24,"phases":590,"briefSummary":592,"conditions":593,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":594,"lastUpdatePostDateStruct":595,"startDateStruct":596,"completionDateStruct":598,"leadSponsor":600,"locationsCount":601},"100596062","phase-2-a-trial-of-varenicline-for-e-cigarette-cessation-100596062","NCT07040566","A Trial of Varenicline for E-cigarette Cessation","Investigating Efficacious E-Cigarette Interventions and Cessation Effects on Cancer-Related Biomarkers: A Randomized Trial of Varenicline in Adults","Inclusion Criteria:\n\n* report daily use of an e-cigarette containing nicotine\n* live in Connecticut or South Carolina\n\nExclusion Criteria:\n\n* regular use of other tobacco products besides e-cigarettes\n* medical contraindications for varenicline use\n* current treatment for tobacco cessation\n* lack proficiency in English",{"count":589,"type":23},326,[591],"PHASE2","This is randomized, placebo-controlled clinical trial in treatment-seeking adults who report regular e-cigarette use to test the hypothesis that varenicline is efficacious for quitting e-cigarettes.",[289,63,29],"2025-12-15",{"date":573,"type":38},{"date":597,"type":38},"2025-10-14",{"date":599,"type":23},"2030-10-30",{"name":304,"class":82},2,{"id":603,"slug":604,"hasResults":12,"nctId":605,"briefTitle":606,"officialTitle":607,"acronym":4,"eligibilityCriteria":608,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":609,"enrollmentInfo":610,"targetDuration":4,"studyType":24,"phases":612,"briefSummary":613,"conditions":614,"keywords":616,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":618,"lastUpdatePostDateStruct":619,"startDateStruct":621,"completionDateStruct":623,"leadSponsor":625,"locationsCount":46},"100557125","phase-4-transcranial-magnetic-stimulation-for-nicotine-dependence-an-effectiveness-implementation-trial-100557125","NCT06534047","Transcranial Magnetic Stimulation for Nicotine Dependence: An Effectiveness-Implementation Trial","Integrating Transcranial Magnetic Stimulation as a Treatment for Nicotine Dependence in the Clinic: A Pragmatic, Hybrid Effectiveness-Implementation Trial","Inclusion Criteria:\n\nPatient Participants:\n\nThe patient participant must meet all the inclusion criteria to be eligible for this study:\n\n1. Able to provide informed consent.\n2. Age 18-70.\n3. Self-reported daily tobacco cigarette consumption.\n4. Meet DSM-5 criteria for a psychiatric disorder that includes one of the following: mood disorders (e.g. major depressive disorder, bipolar disorder), anxiety disorders (e.g. panic disorder, social anxiety disorder), psychotic disorders (e.g. schizophrenia), posttraumatic stress disorder, obsessive compulsive disorders, or other substance use disorders (e.g. alcohol use disorder) as determined by the Structured Clinical Interview for DSM-5 Disorders, Research Version (SCID-5 RV).\n5. Interested in using either Repetitive Transcranial Magnetic Stimulation (rTMS) or nicotine replacement therapy as a smoking cessation treatment.\n6. Intending on quitting smoking within the next 30 days.\n\nExclusion Criteria:\n\nPatient Participants:\n\n1. Contraindication to rTMS according to the TMS Adult Safety Screen (TASS) and PI review.\n2. Have any intracranial implant (e.g., aneurysm clips) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed.\n3. Pregnant or intending to be pregnant during the study.\n4. A history of a primary seizure disorder, seizure associated with an intracranial lesion, recurrent seizures related to substance intoxication or withdrawal or recent seizure within the last 6 months.\n5. Space occupying intracranial lesion.\n6. Any generalized skin disorders precluding the use of the nicotine patch.\n7. Any known hypersensitivity or allergies to the nicotine patch.\n8. Any known life-threatening arrhythmias or severe\u002Fworsening angina pectoris.\n9. Within two weeks of experiencing a myocardial infarction or cerebral vascular accident.\n10. Currently using or has used nicotine replacement therapy within the past two weeks.\n11. Diagnosed with a terminal illness\n12. Current regular use of e-cigarettes or other vaping devices containing nicotine and not willing to stop using these devices for the duration of the study.\n13. Acutely unstable medical, psychiatric, or substance use disorder comorbidity with safety concerns at the discretion of the PI or study physician.\n14. Previous treatment with rTMS for smoking cessation\n15. Treatment with nicotine replacement therapy anytime within the last 1 month","70 Years",{"count":611,"type":23},40,[59],"Tobacco smoking is the leading preventable cause of morbidity and mortality worldwide. However, currently available treatments, including standard pharmacotherapy and behavioural support, are limited in their efficacy, tolerability, and acceptability by patients. Additionally, tobacco use is substantially higher in individuals with comorbid mental illness, constituting a particularly vulnerable population. As such, the development of multiple evidence-based treatments for smoking cessation is of upmost importance.\n\nRepetitive transcranial magnetic stimulation (rTMS) is a non-invasive brain-based approach in which alternating magnetic fields are applied to the scalp to induce electrical currents in cortical tissue. As it can modulate neural circuits implicated in neuropsychiatric disorders, it is a promising brain-based approach in the treatment of substance use disorders. Recently, a deep TMS coil has been cleared by the Food and Drug Administration (FDA) as efficacious for tobacco use disorder, representing the first rTMS indication for addictions. Before adoption of this intervention into smoking cessation clinics, it is important to investigate whether implementation of rTMS into clinical care is feasible, acceptable, and appropriate for patients receiving care for nicotine dependence.\n\nThe objective of this study is to compare the effectiveness of rTMS versus treatment as usual for patients with psychiatric disorders seeking treatment for smoking cessation. Also, barriers to the implementation of rTMS in routine clinical care will be examined by speaking with patients and health care providers on their experience with rTMS.",[198,615,29],"Psychiatric Disorder",[617,29,64],"Repetitive Transcranial Magnetic Stimulation","2025-12-05",{"date":620,"type":38},"2025-12-11",{"date":622,"type":38},"2024-09-01",{"date":624,"type":23},"2026-12-01",{"name":501,"class":82}]