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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-65
SponsorMassachusetts General Hospital

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

30 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Massachusetts General Hospital

Lead sponsor

Brigham and Women's Hospital

Collaborator