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

PHASE4Not yet recruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

October 1, 2025

Primary Completion Date

September 30, 2027

Study Completion Date

December 1, 2027

Conditions
Nicotine DependenceTranscranial Magnetic StimulationVapingSmoking CessationSmoking (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.

Trial Locations (1)

02114

Massachusetts General Hospital, Boston

All Listed Sponsors
lead

Massachusetts General Hospital

OTHER

collaborator

Brigham and Women's Hospital

OTHER