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

Study acronym: V-TMS
StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 11 months later Sep 2027 → Sep 2028
See other at-risk trials from Massachusetts General Hospital

Record History

  1. Primary completion pushed from Sep 2027 to Sep 2028 Completion pushed from Dec 2027 to Dec 2028 · Start date changed from estimate of Aug 2026 to Jul 2, 2026 · Eligibility criteria expanded, about 20 words · 3 more Show 6 more changesShow less
    • Completion pushed from Dec 2027 to Dec 2028
    • Start date changed from estimate of Aug 2026 to Jul 2, 2026
    • Eligibility criteria expanded, about 20 words
    • Secondary endpoints: details revised at 6 of 6 entries
    • Study description expanded, about 32 words
    • Collaborators: details revised at 1 of 1 entry
  2. Recruitment opened Start date: Mar 15, 2026 to Aug 2026 · Primary completion date: Sep 30, 2027 to Sep 2027 · Completion date: Dec 1, 2027 to Dec 2027 · 4 morev3 Show 7 more changesShow less
    • Start date: Mar 15, 2026 to Aug 2026
    • Primary completion date: Sep 30, 2027 to Sep 2027
    • Completion date: Dec 1, 2027 to Dec 2027
    • Interventions: Nicotine Cessation Counseling (Behavioral), Transcranial Magnetic Stimulation (Device), Transcranial Magnetic Stimulation Sham (Device)… to D-cycloserine (Drug), Nicotine Cessation Counseling (Behavioral), Transcranial Magnetic Stimulation (Device), Transcranial Magnetic…
    • Eligibility criteria expanded, about 15 words
    • Study description expanded, about 21 words
    • Site details revised

    See this version in full on ClinicalTrials.gov ↗

  3. Start date: Oct 1, 2025 to Mar 15, 2026v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 study visits * Complete 6 brief, monthly follow up visits * Complete a brief daily survey each day that they take the study drug
Trial Details
NCT Number NCT07145866
Lead Sponsor Massachusetts General Hospital
Collaborators: Brigham and Women's Hospital
Conditions Nicotine Dependence, Transcranial Magnetic Stimulation, Vaping, Smoking Cessation, Smoking (Tobacco) Addiction
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov