Deep Transcranial Magnetic Stimulation for Tobacco Cessation in Adults With Opioid Use Disorder

Conditions

• Opioid Use Disorder
• Tobacco Use Disorder

Eligibility Criteria

Sex

ALL

Age

22 Years - 70 Years

Healthy Volunteers

Not accepted

Interventions

• Deep TMS System With H4 Coil — DEVICE
  Active Deep TMS will be delivered using the Deep TMS System with the H4 coil according to the smoking-cessation protocol. Stimulation will be delivered at 120% of the participant's resting motor threshold, unless a protocol-approved modification is required, at 10 Hz using 3-second trains, a 15-second inter-train interval, 60 trains, and 1,800 pulses per session. Each stimulation session lasts approximately 20 minutes. Participants may receive five sessions per week during Weeks 1 through 3, followed by one session per week during Weeks 4 through 6, for up to 18 sessions total.

Study Details

This pilot study will evaluate the use of deep transcranial magnetic stimulation (Deep TMS) to help adults with opioid use disorder (OUD) who are receiving medications for opioid use disorder (MOUD) such as buprenorphine or methadone and who continue to smoke cigarettes and want to quit. Deep TMS is a noninvasive form of brain stimulation that uses magnetic pulses. The BrainsWay Deep TMS System is FDA-cleared for smoking cessation. This study will use the H4 coil smoking-cessation protocol in people with OUD receiving MOUD. Approximately 12 participants will take part and all participants will receive active Deep TMS. There is no sham or placebo group and no random assignment. Participants may receive up to 18 Deep TMS sessions over 6 weeks: five sessions per week during the first 3 weeks, followed by one session per week during Weeks 4 through 6. Participants will return for a follow-up visit at Week 10. The main purpose of the study is to learn whether this Deep TMS approach is safe, tolerable and feasible for people with OUD receiving MOUD and to estimate how many participants are able to remain smoke-free from Week 6 through Week 10. The study will also look for early changes in tobacco craving, opioid craving, continuation of MOUD, mood and anxiety symptoms, pain, heart rate variability, and participants' experiences with the treatment. The findings will be used to help plan a larger future study.

Key Dates

First listed

Aug 18, 2026

Start date

Jan 31, 2027

Status verified

Aug 2026

Primary completion

Dec 31, 2027

Completion

Dec 31, 2027

Study Design

Enrollment

12 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Active Deep TMS
  Participants will receive active deep transcranial magnetic stimulation (Deep TMS) using the BrainsWay Deep TMS System with the H4 coil. Participants may receive up to 18 sessions over 6 weeks: five sessions per week during Weeks 1 through 3, followed by one session per week during Weeks 4 through 6.

Primary Outcome Measure

Percentage of Participants Achieving Four-Week Continuous Smoking Abstinence (Continuous Quit Rate) [ Time Frame: Weeks 6 through 10 (4-week abstinence window), with outcome determination at Week 10 ]

Central Contacts

• Payel J Roy, MD, MSc
  412-692-4473
  [email protected]
• Gagandeep Singh Shergill, B Pharm, MS
  937-831-8031
  [email protected]

Locations (2)

Find similar trials in Pittsburgh, PA

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