Evaluating Varenicline with Accelerated Transcranial Magnetic Stimulation to Support Adult Nicotine Cessation

What this Trial Is About

Researchers are studying whether combining varenicline medication with enhanced accelerated Transcranial Magnetic Stimulation aTMS can help adults aged 18 to 65 quit using nicotine products. This 12-week randomized, double-blind clinical trial compares varenicline plus active aTMS and a single dose of D-Cycloserine to varenicline plus sham inactive aTMS and placebo. The study aims to assess if active enhanced aTMS leads to higher rates of nicotine abstinence and lower cravings. Participants will take varenicline daily for 12 weeks with a dose schedule increasing to 1 mg twice daily over seven days. They will undergo one day of up to 20 TMS treatments targeted individually based on brain MRI scans done at baseline. Those in the active group receive a single 125 mg dose of D-Cycloserine on the TMS treatment day, while the comparison group receives a placebo pill and sham TMS that mimics treatment sensation without magnetic stimulation. Both groups receive 12 brief nicotine cessation counseling sessions spread throughout the study. During the study, participants will complete two brain MRI scansone at baseline and one after TMS treatments. They will also attend weekly follow-up visits, either in person or virtual, for up to 12 weeks to report nicotine use and complete questionnaires on substance use, depression, and anxiety. A daily survey is completed during the varenicline treatment to track adherence. Researchers will measure nicotine abstinence, brain connectivity, craving, withdrawal symptoms, and mood changes to evaluate treatment effects.

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