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
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 up to 20 treatments in one day.
  • 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 up to 20 treatments in one day. 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 12 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.
  • D-cycloserine — DRUG
    Eligible participants will receive a single dose of 125 mg D-Cycloserine shortly before the start of TMS treatment.

Study Details

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? 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 one day of up to 20 TMS treatments * Take a single dose of D-Cycloserine medication on the day of TMS treatment * Complete 12 brief, weekly follow-up visits * Complete a brief daily survey each day that they take the study drug

Key Dates

First listed
Aug 28, 2025
Start date
Aug 31, 2026
Status verified
Jul 2026
Primary completion
Sep 30, 2027
Completion
Dec 31, 2027

Study Design

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

Arms

  • Active Comparator: Varenicline + Active Enhanced TMS
    In this arm, participants will take 12 weeks of varenicline. They will also receive a single dose of 125 mg D-Cycloserine and one day of up to 20 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 12 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 one day of up to 20 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 12 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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