[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100604157":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":43,"centralContacts":47,"locations":56,"responsibleParty":71,"collaborators":74,"id":77,"slug":28,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":78,"sex":84,"minAge":85,"maxAge":86,"enrollmentInfo":87,"targetDuration":28,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":99,"overallStatus":106,"whyStopped":28,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},{"fullName":5,"class":6},"Massachusetts General Hospital","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Varenicline + Active TMS","ACTIVE_COMPARATOR","In this arm, participants will take 12 weeks of varenicline. They will also receive 5 consecutive days of 5 hourly TMS treatments, adjusted to an individualized target specific to the participant based on their brain MRI collected at the baseline imaging visit. Participants will also receive 6 brief nicotine cessation counseling sessions.",[13,14,15],"Drug: varenicline","Device: Transcranial Magnetic Stimulation","Behavioral: Nicotine Cessation Counseling",{"label":17,"type":18,"description":19,"interventionNames":20},"Varenicine + Sham TMS","SHAM_COMPARATOR","In this arm, participants will receive 12 weeks of varenicline and instructions on how to take it. They will also receive 5 consecutive days of 5 hourly TMS treatments, adjusted to an individualized target specific to the participant based on their brain MRI collected at the baseline imaging visit. However, the sham setting will deliver no magnetic field to the brain; instead, it will deliver electrical current to the scalp to mimic the feel of active treatment. Participants will also receive 6 brief nicotine cessation counseling sessions.",[13,21,15],"Device: Transcranial Magnetic Stimulation Sham",[23,29,34,38],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","varenicline","Dosing of this FDA-approved medication will follow the below schedule, which follows the clinical standard:\n\n0.5 mg once daily or 3 days, 0.5 mg twice daily for 4 days 1.0 mg twice daily for 11 weeks",[17,9],null,{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":28},"DEVICE","Transcranial Magnetic Stimulation","Transcranial magnetic stimulation (TMS) is a noninvasive FDA-approved technique that is commonly used as a treatment for depression and has been approved for use in smoking cessation. In this study, TMS will be administered within FDA-approved guidelines under the supervision of a physician with experience in administering the treatment and monitoring for complications. Following an accelerated model, it will consist of 5 hourly treatments for 5 consecutive days.",[9],{"type":30,"name":35,"description":36,"armGroupLabels":37,"otherNames":28},"Transcranial Magnetic Stimulation Sham","Transcranial magnetic stimulation (TMS) is a noninvasive FDA-approved technique that is commonly used as a treatment for depression and has been approved for use in smoking cessation. In this study, TMS will be administered within FDA-approved guidelines under the supervision of a physician with experience in administering the treatment and monitoring for complications. Following an accelerated model, it will consist of 5 hourly treatments for 5 consecutive days. The sham setting will deliver no magnetic field to the brain but will deliver electrical current to the scalp to mimic the feel of active treatment.",[17],{"type":39,"name":40,"description":41,"armGroupLabels":42,"otherNames":28},"BEHAVIORAL","Nicotine Cessation Counseling","Each participant will receive 6 sessions of brief nicotine cessation counseling by a trained study staff member. This will be provided at the weekly follow-up visits, spread out throughout the study. This counseling, while not the main aim of the study, should help participants manage their expectations of quitting and provide support and quitting strategies throughout the process.",[17,9],[44],{"name":45,"affiliation":5,"role":46},"Jodi M Gilman, PhD","PRINCIPAL_INVESTIGATOR",[48,52],{"name":45,"role":49,"phone":50,"phoneExt":28,"email":51},"CONTACT","617-643-7293","jgilman1@mgh.harvard.edu",{"name":53,"role":49,"phone":54,"phoneExt":28,"email":55},"Julia Jashinski, MSW","617-643-1984","jjashinski@mgh.harvard.edu",[57],{"facility":5,"status":28,"city":58,"state":59,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"Boston","Massachusetts","02114","United States","US",{"type":64,"coordinates":65},"Point",[66,67],-71.05977,42.35843,{"lat":67,"lon":66},[70],{"name":45,"role":49,"phone":50,"phoneExt":28,"email":51},{"type":46,"investigatorFullName":72,"investigatorTitle":73,"investigatorAffiliation":5,"oldNameTitle":28,"oldOrganization":28},"Jodi Gilman","Associate Professor, Harvard Medical School; Director of Neuroscience, Center for Addiction Medicine, Massachusetts General Hospital",[75],{"name":76,"class":6},"Brigham and Women's Hospital","100604157",false,"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* 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.).","ALL","18 Years","65 Years",{"count":88,"type":89},30,"ESTIMATED","INTERVENTIONAL",[92],"PHASE4","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",[95,31,96,97,98],"Nicotine Dependence","Vaping","Smoking Cessation","Smoking (Tobacco) Addiction",[96,100,101,102,103,104,31,105],"Smoking","Nicotine","Adults","Cessation","Varenicline","TMS","NOT_YET_RECRUITING","2026-01-14",{"date":109,"type":110},"2026-01-16","ACTUAL",{"date":112,"type":89},"2026-03-15",{"date":114,"type":89},"2027-12-01",{"name":5,"class":6},1]