Varenicline plus enhanced TMS to help adults quit smoking and vaping

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this randomized, double-blind study, 30 adults with nicotine dependence will receive varenicline for 12 weeks while undergoing up to 20 sessions of enhanced aTMS or sham stimulation. Participants are assessed with MRI, behavioral questionnaires, and urine tests at baseline, during treatment, and after treatment, to measure abstinence rates and cravings. One dose of D-Cycloserine is given with the active TMS treatment to see if it boosts quit rates. The trial uses a 9-month parallel design to compare the two arms and tracks weekly visits during treatment and monthly follow-ups afterward.

Why it matters

Who can join: the full rules

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.).

Where it's running

• Massachusetts General Hospital
  Boston, Massachusetts, United States Recruiting

Study contacts

• Principal investigator: Jodi M Gilman, PhD — Massachusetts General Hospital
• Study coordinator: Jodi M Gilman, PhD
• Email: jgilman1@mgh.harvard.edu
• Phone: 617-643-7293

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Varenicline to help adults stop vaping

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• ACT Lung Health Program to help Chinese and Korean American smokers quit

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.