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NCT07145866 · ClinicalTrials.gov registry record · Phase 4

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

A Phase 4 study, sponsored by Massachusetts General Hospital.

Not yet
Registry status
Phase 4
Development phase
30
Enrollment target

NCT07145866: Clinical Trial Phase 4 study, sponsored by Massachusetts General Hospital.

NCT07145866 is a Phase 4 study that has not yet begun recruiting, run by Massachusetts General Hospital. The registered enrollment target is 30 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT07145866, a Phase 4 study, has not yet begun recruiting, sponsored by Massachusetts General Hospital.

NOT YET RECRUITING
Registry status
Phase 4
Development phase
30 participants
Enrollment target

Study Summary

The goal of this clinical trial is to learn if a combination of varenicline and accelerated Transcranial Magnetic Stimulation (aTMS) works to help adults quit using nicotine products. Researchers will compare varenicline + active aTMS to varenicline + sham (inactive) aTMS to see the effect of aTMS on reaching abstinence. The main question it aims to answer is: Does receiving active 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 5 consecutive days (Monday-Friday, uninterrupted) of TMS treatments * Complete 12 brief, weekly follow-up visits * Complete a brief daily survey each day that they take the study drug

Primary Outcome

Point-prevalence abstinence from e-cigarette use was defined as self-report of no e-cigarette use since the last visit, bioverified by saliva cotinine \<30 ng/ml. Continuous abstinence is defined as observed point-prevalence abstinence over specified study visits at weeks 9, 10, 11 and 12. The primary analysis will compare the proportion of participants achieving continuous abstinence in the enhanced aTMS + varenicline group versus the Sham + varenicline group using a chi-square test. If expecte

Interventions

  • DEVICE Transcranial Magnetic Stimulation
  • DEVICE Transcranial Magnetic Stimulation Sham
  • DRUG varenicline
  • BEHAVIORAL Nicotine Cessation Counseling

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2026-03-15
Est. Completion 2027-12-01
Phase Phase 4
Massachusetts General Hospital

2,032 total trials

What is known before NCT07145866 opens enrollment

NCT07145866 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower).

The record links to 0 conditions, and to 4 interventions - of which Transcranial Magnetic Stimulation is the first listed.

NCT07145866 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT07145866 about?

NCT07145866 is a clinical study titled "Varenicline and Accelerated Transcranial Magnetic Stimulation (TMS) for Quitting Nicotine Use (Pilot Study)". The goal of this clinical trial is to learn if a combination of varenicline and accelerated Transcranial Magnetic Stimulation (aTMS) works to help adults quit using nicotine products. Researchers will compare varenicline + active aTMS to varenicline + sham (inactive) aTMS to see the effect of aTMS o...

What is the current status of trial NCT07145866?

This trial is currently not yet recruiting. It is a Phase 4 study. The enrollment target is 30 participants. The study started on 2026-03-15. Estimated completion is 2027-12-01.

What interventions are being tested in trial NCT07145866?

The interventions under investigation include: Transcranial Magnetic Stimulation (DEVICE), Transcranial Magnetic Stimulation Sham (DEVICE), varenicline (DRUG), Nicotine Cessation Counseling (BEHAVIORAL).

Who is sponsoring clinical trial NCT07145866?

This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.

Learn More About Clinical Trials

How this trial's enrollment target compares

Where NCT07145866's enrollment target sits among peer trials

30 1552nd of 2000 higher than 367 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT07145866, the US trial registry maintained by the National Library of Medicine. NCT07145866 (small enrollment · none site footprint · not yet recruiting) retrieved and formatted by PlainTrial, see methodology.