Not Yet RecruitingPhase 4

Varenicline and Accelerated Transcranial Magnetic Stimulation (TMS) for Quitting Nicotine Use (Pilot Study)

United States30 participantsStarted 2026-03-15

Plain-language summary

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? Participants will be asked to: * Complete 2 brain MRI scans * Take varenicline every day for 12 weeks * Quit using nicotine products at the end of the second week of varenicline * Complete 5 consecutive days (Monday-Friday, uninterrupted) of TMS treatments * Complete 12 brief, weekly follow-up visits * Complete a brief daily survey each day that they take the study drug

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age ≥ 18 and ≤65; * The ability to give written, informed consent; * Fluency in English; * Reported interest in quitting nicotine vaping or smoking within the next month; * 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); * Smoke or vape nicotine daily for at least the past 90 days, as confirmed by self-report and timeline follow-back methods; * Saliva cotinine \>30ng/mL; Exclusion Criteria: * Pregnancy or breastfeeding; * Use of smoking cessation pharmacotherapy in the past month; * Unwilling to abstain during the study from using smoking cessation aids other than those provided by the study; * Prior adverse drug reaction to varenicline; * Receiving or planning to receive other TMS treatments or investigational drugs during course of participation * Contraindications to TMS (including seizures, metallic implants, severe existing tinnitus, etc.); * 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); * 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; * History of seizures and/or history of TBI subtypes associated with elevated seizure risk (e.g. penetra…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Biochemically-confirmed continuous nicotine abstinence across study weeks 9-12

Timeframe: Week 9-Week 12

Resting State Functional Connectivity (rsFC)

Timeframe: Baseline, Week 12

Change in Insula Activation to Nicotine Cues During a Cue Reactivity Task Measured by fMRI

Timeframe: Baseline, Week 12

Trial details

NCT IDNCT07145866

SponsorMassachusetts General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-09-30

Contact for this trial

Jodi M Gilman, PhD

617-643-7293 jgilman1@mgh.harvard.edu

View on ClinicalTrials.gov More Nicotine Dependence trials