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

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

Conditions

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

Interventions

DRUG

varenicline

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

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.

DEVICE

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.

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.

Sponsors & Collaborators

• Brigham and Women's Hospital

  collaborator OTHER

• Massachusetts General Hospital

  lead OTHER

Principal Investigators

• Jodi M Gilman, PhD · Massachusetts General Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-03-15

Primary Completion

2027-09-30

Completion

2027-12-01

FDA Drug

Yes

FDA Device

Yes

Countries

• United States

Study Locations