NCT07145866 Varenicline and Accelerated Transcranial Magnetic Stimulation (TMS) for Quitting Nicotine Use (Pilot Study)
| NCT ID | NCT07145866 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Massachusetts General Hospital |
| Condition | Nicotine Dependence |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2026-08 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 30 participants in total. It began in 2026-08 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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.).
Contact & Investigator
Jodi M Gilman, PhD
PRINCIPAL INVESTIGATOR
Massachusetts General Hospital
Frequently Asked Questions
Who can join the NCT07145866 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Nicotine Dependence. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07145866 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07145866 currently recruiting?
Yes, NCT07145866 is actively recruiting participants. Contact the research team at jgilman1@mgh.harvard.edu for enrollment information.
Where is the NCT07145866 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT07145866 clinical trial?
NCT07145866 is sponsored by Massachusetts General Hospital. The principal investigator is Jodi M Gilman, PhD at Massachusetts General Hospital. The trial plans to enroll 30 participants.