About this trial
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
Eligibility criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Varenicline
- Transcranial Magnetic Stimulation
- Transcranial Magnetic Stimulation Sham
- Nicotine Cessation Counseling
- D-cycloserine
Treatment groups
Sponsors and collaborators
Massachusetts General Hospital
Lead sponsor
Brigham and Women's Hospital
Collaborator