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

NCT07770555 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2026-08-18

No results posted yet for this study

Summary

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.

Conditions

Interventions

DEVICE

Deep TMS System With H4 Coil

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.

Sponsors & Collaborators

  • Payel Roy

    lead OTHER

Principal Investigators

  • Payel J Roy, MD, MSc · University of Pittsburgh

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2027-01-31
Primary Completion
2027-12-31
Completion
2027-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07770555 on ClinicalTrials.gov