Status:
NOT_YET_RECRUITING
Varenicline and Accelerated Transcranial Magnetic Stimulation (TMS) for Quitting Nicotine Use (Pilot Study)
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Brigham and Women's Hospital
Conditions:
Nicotine Dependence
Transcranial Magnetic Stimulation
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
The goal of this clinical trial is to learn if a combination of varenicline and accelerated Transcranial Magnetic Stimulation (TMS) works to help adults quit using nicotine products. Researchers will ...
Detailed Description
This is a 12-week randomized parallel design, double-blind, 2-arm clinical trial consisting of a combination of circuit-targeted TMS and varenicline in 30 adults aged 18-65 with nicotine use disorder ...
Eligibility Criteria
Inclusion
- 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
- 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;
- 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.).
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT07145866
Start Date
October 1 2025
End Date
December 1 2027
Last Update
August 28 2025
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114