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RECRUITING

NCT07145866

PHASE4

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

Sponsor: Massachusetts General Hospital

View on ClinicalTrials.gov

Summary

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

Official title: Evaluation of Varenicline and Accelerated TMS for Reduction of Nicotine Use

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-08

Completion Date

2027-12

Last Updated

2026-07-13

Healthy Volunteers

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 up to 20 treatments in one day.

DEVICE

Transcranial Magnetic Stimulation Sham

BEHAVIORAL

Nicotine Cessation Counseling

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.

DRUG

D-cycloserine

Eligible participants will receive a single dose of 125 mg D-Cycloserine shortly before the start of TMS treatment.

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; * Contraindication to D-Cycloserine (including allergy to D-Cycloserine, significant renal impairment or known kidney disease, pregnancy) * 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. penetrating injury and intraparenchymal hemorrhage) * History of unstable neurological illness or major medical illness, such as epilepsy or renal impairment, in the past six months, unless clearly resolved; * In the opinion of the investigators, evidence of active problem substance use severe enough to compromise ability to safely participate; * In the opinion of the investigators, unable to safely participate in this study and/or provide reliable data (e.g., claustrophobia, unable to tolerate TMS or MRI procedures, etc.).

Locations (1)

Massachusetts General Hospital

Boston, Massachusetts, United States