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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT07145866
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Nicotine Dependence
  • Smoking (Tobacco) Addiction
  • Smoking Cessation
  • Transcranial Magnetic Stimulation
  • Vaping

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • varenicline — DRUG
    Dosing of this FDA-approved medication will follow the below schedule, which follows the clinical standard: 0.5 mg once daily or 3 days, 0.5 mg twice daily for 4 days 1.0 mg twice daily for 11 weeks
  • Transcranial Magnetic Stimulation — DEVICE
    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.
  • Transcranial Magnetic Stimulation Sham — DEVICE
    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.
  • Nicotine Cessation Counseling — BEHAVIORAL
    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.

Study Details

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

Key Dates

Start date
Mar 15, 2026
Status verified
Jan 2026
Primary completion
Sep 30, 2027
Completion
Dec 1, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Varenicline + Active TMS
    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.
  • Sham Comparator: Varenicine + Sham TMS
    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.

Primary Outcome Measure

Biochemically-confirmed continuous nicotine abstinence across study weeks 9-12 [ Time Frame: Week 9-Week 12 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114
Jodi M Gilman, PhD
[email protected]
617-643-7293

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By research site
Massachusetts General Hospital· Boston, MA

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