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Taking people in United StatesPhase 4

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

Key facts

Who runs it
Massachusetts General Hospital
Where
Boston, United StatesSee the site
Trial code
Status
Recruiting
Phase
Phase 4
People taking part
30 people, planned
Started
2 Jul 2026
Expected to end
Dec 2028
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Varenicline
  • Transcranial Magnetic Stimulation
  • Transcranial Magnetic Stimulation Sham
  • Nicotine Cessation Counseling
  • D-cycloserine
Record updated
15 September 2026

Who can take part

Age
18 years to 65 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 20 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Prior adverse drug reaction to varenicline
  • Receiving or planning to receive other TMS treatments or investigational drugs during course of participation
  • 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)
  • Contraindication to D-Cycloserine (including allergy to D-Cycloserine, significant renal impairment or known kidney disease, pregnancy)
  • Contraindications to TMS (including seizures, metallic implants, severe existing tinnitus, etc.)
  • 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
  • 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
  • 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.)

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 65 years old?

Where in United States

  • Massachusetts General HospitalBoston, United StatesContact: Jodi M Gilman, PhDTaking people

About the trial

What the trial wants to find out

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?

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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

The 2 groups in the trial

  • Varenicline + Active Enhanced TMSExisting treatment, for comparison

    In this arm, participants will take 12 weeks of varenicline. They will also receive a single dose of 125 mg D-Cycloserine and one day of up to 20 TMS treatments, adjusted to an individualized target specific to the participant based on their brain MRI collected at the baseline imaging visit. Participants will also receive 12 brief nicotine cessation counseling sessions.

    Treatment: Varenicline, Transcranial Magnetic Stimulation, Nicotine Cessation Counseling, and D-cycloserine

  • Varenicine + Sham TMSSham treatment, for comparison

    In this arm, participants will receive 12 weeks of varenicline and instructions on how to take it. They will also receive one day of up to 20 TMS treatments, adjusted to an individualized target specific to the participant based on their brain MRI collected at the baseline imaging visit. However, the sham setting will deliver no magnetic field to the brain; instead, it will deliver electrical current to the scalp to mimic the feel of active treatment. Participants will also receive 12 brief nicotine cessation counseling sessions.

    Treatment: Varenicline, Transcranial Magnetic Stimulation Sham, and Nicotine Cessation Counseling

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Evaluation of Varenicline and Accelerated TMS for Reduction of Nicotine Use
Fit questions
Built from NCT07145866, who can take part
Record updated
15 September 2026