[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"nicotine\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:nicotine":34},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,50,77,108],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":35,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100638376","support-your-heart-phase-1-100638376",false,"NCT07623733","Support Your Heart, Phase 1","Support Your Heart: Feasibility Trial of a Cardiovascular Health Intervention for Young Adults, Phase 1","SYH","Inclusion Criteria:\n\n1. 18-39 at time of enrollment\n2. Living in Washington DC area\n3. At least two risk factors for cardiovascular disease:\n\n   1. not enough sleep\n   2. insufficient physical activity\n   3. tobacco and nicotine product use\n   4. elevated body mass index\n   5. poor diet\n   6. high cholesterol\n   7. high blood pressure; and\u002For\n   8. elevated HbA1c.\n\nExclusion Criteria:\n\n* 1\\. Major medical condition or chronic disease that would impede physical activity or increase the risk of the intervention (e.g., reported type 1 or type 2 diabetes, cerebrovascular accident, systolic blood pressure \\>180 mmHg or diastolic blood pressure \\>105 mmHg, renal disease, pulmonary disease dependent on oxygen, recent orthopedic injury, significant surgery within the last 6 months, HbA1c \\>6.5%, total cholesterol \\>240 mg\u002FdL); 2. Plan to become pregnant during study duration; 3. Psychiatric hospitalization, psychosis or suicide attempt within the last 12 months; 4. Alcohol or substance use disorder; 5. An eating disorder; 6. Conditions or behaviors that are likely to interfere with the conduct of the trial (e.g., inability to communicate with study staff, unwillingness to accept any of the three treatment assignments by randomization, current participation in another physical activity or lifestyle intervention research program)",true,"ALL","18 Years","39 Years",{"count":22,"type":23},20,"ESTIMATED","INTERVENTIONAL",[26],"NA","This is a pilot feasibility study designed to establish the feasibility and acceptability of the \"Support Your Heart\" (SYH) study's phone-based protocols regarding AHA's LE8, social isolation, loneliness, and stress.\n\nThe age range for this intervention is 18-39, which is intended to reflect the transitional life period from adolescence to adulthood. Participants must also display at least two LE8 risk factors for cardiovascular disease (e.g., not enough sleep or physical activity; tobacco\u002Fnicotine product use; elevated body mass index; high cholesterol, high blood pressure, elevated HbA1c , and\u002For poor diet).\n\nParticipants will receive weekly calls (averaging around 20-30 minutes each) from a SYH health coach in order to review key concepts, give personalized progress, and provide consistent feedback over the course of 12 weeks. SYH staff will measure improvement in AHA metrics as well as participant burden, acceptability, satisfaction, adherence, and retention. This research has the potential to create substantial public health impact by addressing cardiovascular health, social isolation, loneliness, and stress, all of which represent significant burdens to individual health.",[29,30,31,32,33,34],"Cardio Vascular Disease","Obesity & Overweight","Physical Activity","Sleep","Diet, Healthy","Nicotine",[36],"Life's Essential 8","RECRUITING","2026-05-28",{"date":40,"type":41},"2026-06-03","ACTUAL",{"date":43,"type":23},"2026-06-01",{"date":45,"type":23},"2026-10-01",{"name":47,"class":48},"George Washington University","OTHER",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":24,"phases":58,"briefSummary":59,"conditions":60,"keywords":64,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":73,"leadSponsor":75,"locationsCount":49},"100619715","pharmacokinetics-and-pharmacodynamics-of-synthetic-nicotine-and-nicotine-analogues-100619715","NCT07348224","Pharmacokinetics and Pharmacodynamics of Synthetic Nicotine and Nicotine Analogues","Inclusion Criteria:\n\n* Men or women, age 18 or older at screening who have used EC with nicotine during at least 10 of the past 30 days\n* Saliva cotinine concentration of \\> 30 ng\u002FmL at screening\n* Ability to communicate well with the investigator and to understand and comply with the requirements of the study\n* Women of child-bearing age engaging in sexual activities which can lead to pregnancy: willingness of using a reliable\u002Fhormonal contraception method during the study (hormonal, e.g. pill, intrauterine devices, or mechanical method, e.g. condom, diaphragm)\n* Signed informed consent form\n\nExclusion Criteria:\n\n* Known hypersensitivity\u002Fallergy to a content of the e-liquids\n* Smoking of more than 5 cigarettes per day in the past 30 days\n* Pregnant or lactating women\n* Intention to become pregnant during the course of the study\n* BMI \\\u003C 18 or \\> 30 kg\u002Fm2 at screening\n* History or clinical evidence of alcoholism or drug abuse within the 3-year period prior to screening\n* Loss of ≥ 250 mL of blood within 3 months prior to screening, including blood donation\n* Treatment with an investigational drug within 30 days prior to screening\n* Treatment with prescribed or over-the-counter medications with known influence on CYP2A6 function within 1 week prior to screening (with the exception of contraception)\n* History or clinical evidence of any disease (e.g. gastrointestinal tract-disease) and\u002For existence of any surgical or medical condition, which in the opinion of the investigator might interfere with the absorption, distribution, metabolism or excretion of the study drugs, or which might increase the risk of toxicity.\n* Legal incapacity or limited legal capacity at screening\n* Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol",{"count":57,"type":23},24,[26],"Electronic cigarettes are battery-operated devices that can produce an aerosol by heating a liquid which commonly contains nicotine. In recent years, products containing synthetically produced nicotine and nicotine analogues have entered the market. However, it remains unclear whether these types of nicotine have the same effects as conventional nicotine derived from the tobacco plant. The aim of this study is to investigate the effects of these nicotine types and to gain a better understanding of their respective mechanisms of action.",[34,61,62,63],"Vaping","Synthetic Nicotine","Nicotine Analogues",[65,66,67],"synthetic nicotine","nicotine analogues","vaping","NOT_YET_RECRUITING","2026-04-28",{"date":71,"type":41},"2026-04-29",{"date":43,"type":23},{"date":74,"type":23},"2026-12-31",{"name":76,"class":48},"Insel Gruppe AG, University Hospital Bern",{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":85,"targetDuration":4,"studyType":24,"phases":87,"briefSummary":88,"conditions":89,"keywords":92,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":4},"100614044","smoking-harm-reduction-using-e-cigarettes-and-cytisine-100614044","NCT07274475","Smoking Harm Reduction Using E-cigarettes and Cytisine","Exploring Alternative Approaches to Harm Reduction and Cessation for Treatment-Resistant Tobacco Dependence","SHRECC","Inclusion Criteria:\n\n1. Willingness to comply with all study procedures, for the full duration of the study period (12 months);\n2. Age 18 years or older;\n3. Currently smoking 5 or more cigarettes daily; and\n4. Must have regular access to a phone and email to receive study communications and complete study monitoring.\n\nExclusion Criteria:\n\n1. Individuals who smoke only occasionally or have quit smoking prior to the 6-month follow-up;\n2. Daily or almost daily users of e-cigarettes for the past 30 days;\n3. Presence of medical or psychiatric conditions that may interfere with safe participation or compliance with the study protocol, including severe cardiovascular disorders, renal impairment or respiratory conditions;\n4. Known allergy or hypersensitivity to any components of the e-cigarettes, e-liquids, or cytisine;\n5. Pregnant or breastfeeding, or planning to become pregnant within the next 12 months; or\n6. Current use of pharmacological smoking cessation aids or participation in other smoking cessation clinical trials.",{"count":86,"type":23},6000,[26],"Smoking remains the leading cause of preventable death globally, with high prevalence in disadvantaged populations despite access to free nicotine replacement therapy (NRT) and counseling through Ontario's STOP Program. This study aims to evaluate the acceptability, feasibility, and comparative effectiveness of e-cigarettes and cytisine as harm-reduction tools for individuals who continue to smoke despite standard treatments. Over four years, 6,000 STOP participants who smoke ≥5 cigarettes daily at six months post-treatment will be randomized to receive either an e-cigarette starter kit or a 28-day cytisine supply. Data will be collected via REDCap and include biomarkers (NNAL, PAH), self-reported smoking behavior, nicotine dependence, and quality of life. Statistical analyses will assess changes and compare outcomes between groups. Results will inform public health strategies and enhance equitable cessation support for underserved populations.",[90,91,34],"Tobacco Smoking","Harm Reduction",[93,94,95,96,97,98],"Cytisine","E-cigarettes","Smoking cessation","treatment-resistant","Addiction","Clinical intervention","2026-03-17",{"date":101,"type":41},"2026-03-19",{"date":103,"type":23},"2026-05-01",{"date":105,"type":23},"2028-03",{"name":107,"class":48},"Centre for Addiction and Mental Health",{"id":109,"slug":110,"hasResults":11,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":4,"eligibilityCriteria":114,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":115,"enrollmentInfo":116,"targetDuration":4,"studyType":24,"phases":118,"briefSummary":120,"conditions":121,"keywords":126,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":49},"100618205","phase-4-impact-of-daridorexant-on-sleep-daytime-alertness-and-smoking-100618205","NCT07328594","Impact of Daridorexant on Sleep, Daytime Alertness, and Smoking","Impact of Daridorexant on Sleep, Daytime Alertness, and Smoking During Abstinence","INCLUSION\n\n1. Adult participants who are cigarette smokers, 18-55 years of age.\n2. Smokers: greater than 10 cigarettes\u002Fday.\n3. Smoking for 1 year or longer.\n4. Willingness to try to reduce or stay abstinent from cigarettes, smoking cessation aides (including nicotine gum or patches), smokeless tobacco, or electronic cigarettes for 3 weeks during the study.\n5. Willingness to monitor sleep at home with an external device and maintain a simple sleep and smoking diary for 3 weeks.\n6. Willingness to take a 5-min, mobile-based test 3X\u002Fday for 3 days\u002Fweek during the 3 weeks.\n7. Ability to travel to three Study Visits.\n8. Are willing to abstain from consuming grapefruit products during the study.\n9. Have an iPhone, best with iOS 17 or newer.\n\nEXCLUSION:\n\n1. Are currently taking any pharmaceutical drugs for smoking cessation, including: Nicotine patch or nicotine gum, buproprion (Wellbutrin, Zyban), varenicline (Chantix, Champix), other behavioral interventions such as cognitive behavioral therapy for smoking.\n2. Are currently using cannabis or alcohol for sleep. Are currently taking any pharmaceutical drugs for insomnia, such as eszopiclone (Lunesta), zaleplon (Sonata) or zolpidem (Ambien, Ambien CR, Edluar, and Zolpimist) benzodiazepines, or opioids.\n3. Are currently taking stimulants commonly used for ADHD, such as methylphenidate (Ritalin Concerta, Daytrana) or amphetamines (Adderall, Dexedrine, Vyvanse).\n4. Are currently taking anti-seizure drugs, including lamotrigine, pregabalin (Lyrica), or gabapentin (Neurontin, Horizant, or Gralise).\n5. Have non-nicotine substance dependence (diagnosed with substance use disorder, including alcohol or cannabis use disorder (current cannabis use is acceptable, and past illicit drug use is acceptable if greater than 2 months prior to testing and does not meet current criteria for substance use disorders (SUDs) according to DSM-5).\n6. Have a major neurological disorder such as Parkinson's disease, epilepsy, Alzheimer's disease, multiple sclerosis, or any other serious neurological disorder.\n7. Have a history of serious psychiatric disorders including bipolar disorder, schizophrenia, or suicidality.\n8. Had a stroke or head injury which caused loss of consciousness for longer than three minutes in the past 1 year.\n9. Are pregnant or breastfeeding.\n10. Have been diagnosed with sleep apnea or other diagnosed sleep disorders such as narcolepsy.\n11. Have been diagnosed with thyroid problems.\n12. Have been diagnosed with COPD.\n13. Have been doing variable shift work in the past 1 month or traveled more than 1 time zone in past month.\n14. Are currently taking the following medications, supplements, or food: Daridorexant can interact with strong inhibitors of CYP3A4, which should be discussed with The Study Doctor's office (some of these include clarithromycin, diltiazem, erythromycin, itraconzale, ketoconazole, ritonavir, and verapamil).\n15. Have a BMI of 33 or higher.","55 Years",{"count":117,"type":23},44,[119],"PHASE4","Tobacco use is the leading cause of preventable death in the U.S., with 480,000 deaths per year and 7.7 million deaths globally. A major clinical symptom associated with abstinence from both licit and illicit drugs is insomnia, which is a clinically verified, major risk factor for relapse. Roughly half of the 40 million smokers in the U.S. attempt to quit annually, with very low rates of success. One major hurdle is poor sleep quality during abstinence. Compounding the problem is that some pharmaceuticals to help reduce smoking can increase insomnia. Poor sleep is recognized as a major impediment to maintaining abstinence from several drugs of abuse, including nicotine. Blockers of orexin have recently been proposed as a promising therapy for smoking cessation. Insomnia has been reported in up to 40% of smokers, and 80% report regular sleep disturbances, which can be amplified during abstinence. A new orexin blocker, daridorexant, was FDA approved within the past two years for the treatment of insomnia, and while it has been tested in healthy individuals with insomnia, it has not been tested in smokers, who suffer from insomnia, particularly during the withdrawal phase when trying to quit. Daridorexant has an improved profile of beneficial effects for those with insomnia, the most notable advantage being its shorter duration of action that promotes daytime alertness, which is problematic for both active smokers and smokers during withdrawal. Poor sleep leads to daytime sleepiness, which often leads to smoking to maintain alertness.",[122,34,123,97,124,125,32],"Smoking","Tobacco","Substance Use Disorders","Insomnia",[125,127,122,34,123,32,97,128],"Daridorexant","Substance use disorders","2026-01-07",{"date":131,"type":41},"2026-01-09",{"date":133,"type":23},"2026-02-10",{"date":135,"type":23},"2027-09-30",{"name":137,"class":48},"Legacy Health System"]