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

Recruiting now · Phase 4 · Has a placebo group

Conditions studied: Nicotine Dependence, Transcranial Magnetic Stimulation, Vaping, Smoking Cessation, Smoking (Tobacco) Addiction

In brief

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 facts

Study ID

NCT07145866

Run by

Massachusetts General Hospital

People needed

30

Starts

2026-08-01

Expected to finish

2027-12-01

Last updated by the study team

2026-07-13

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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;

You may not qualify if…

• 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.).

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.