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 cleared by the U.S. Food and Drug Administration (FDA) 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
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 hertz (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.
UPMC Presbyterian
Pittsburgh, Pennsylvania, United States
University of Pittsburgh Medical Center (UPMC) Mercy - Internal Medicine Recovery Engagement Program (IM-REP)
Pittsburgh, Pennsylvania, United States
Percentage of Participants Achieving Four-Week Continuous Smoking Abstinence (Continuous Quit Rate)
Continuous smoking abstinence is defined as no cigarettes smoked during the prespecified Weeks 6 through 10 abstinence window based on the daily smoking diary, with abstinence verified by urine cotinine at the Week 10 follow-up visit. Each participant will be classified as meeting or not meeting the continuous quit criteria, and the outcome will be summarized as the percentage of participants meeting the criteria.
Time frame: Weeks 6 through 10 (4-week abstinence window), with outcome determination at Week 10
Mean Opioid Craving Scale-3 (OCS-3) Total Score
Opioid craving will be measured using the 3-item Opioid Craving Scale-3 (OCS-3). Each item is rated from 0 to 10, and the three items are summed to produce a total score ranging from 0 to 30. Higher total scores indicate greater opioid craving or urge to use opioids. OCS-3 will be collected at baseline, before and after each active Deep TMS session during Weeks 1 through 6, and at Week 10. For reporting, each participant's pre-session scores and post-session scores will be averaged separately within the acute treatment phase (Weeks 1 through 3) and maintenance treatment phase (Weeks 4 through 6). These participant-level phase means will then be summarized across participants. Baseline and Week 10 scores will be summarized separately.
Time frame: Baseline (Week 0); acute treatment phase (Weeks 1-3), with pre- and post-session scores summarized separately; maintenance phase (Weeks 4-6), with pre- and post-session scores summarized separately; Week 10 follow-up.
Percentage of Participants Maintaining Continuous Medication for Opioid Use Disorder (MOUD) Without a Gap Greater Than 14 Days
MOUD continuity is defined for each analysis window as no gap greater than 14 consecutive days without verified MOUD coverage. Each participant will be classified as maintaining or not maintaining continuous MOUD during each window. The outcome will be summarized as the percentage of participants maintaining continuous MOUD for each analysis window.
Time frame: Baseline through Week 3; Baseline through Week 6; Baseline through Week 10
Medication for Opioid Use Disorder (MOUD) Coverage Measured by Percent Days Covered (PDC)
MOUD coverage will be measured as Percent Days Covered (PDC) for each analysis window. PDC is calculated as the number of days with verified MOUD coverage divided by the total number of days in the analysis window, multiplied by 100. PDC ranges from 0% to 100%, with higher percentages indicating greater consistency of MOUD availability or receipt. PDC will be summarized continuously for each analysis window.
Time frame: Baseline through Week 3; Baseline through Week 6; Baseline through Week 10.
Mean Percentage of Planned Deep TMS Sessions Attended per Participant
For each participant, the session completion rate will be calculated as the number of planned Deep TMS sessions attended divided by the number of planned Deep TMS sessions, multiplied by 100. Participants may receive up to 18 planned sessions: 15 acute-treatment sessions during Weeks 1 through 3 and 3 maintenance sessions during Weeks 4 through 6. The outcome will be summarized across participants as the mean percentage with standard deviation. Higher percentages indicate greater treatment-session completion.
Time frame: From the first Deep TMS session (Week 1) through the end of treatment (Week 6)
Percentage of Attended Deep TMS Sessions Meeting All Protocol Delivery Fidelity Criteria
Treatment delivery fidelity will be calculated as the number of attended active Deep TMS sessions that meet all applicable protocol delivery criteria divided by the total number of attended active Deep TMS sessions, multiplied by 100. Fidelity criteria include completion of required safety and setup checks, appropriate H4 helmet/coil positioning, device readiness with no unresolved faults, documentation of the resting motor threshold source, stimulation intensity of 120% of resting motor threshold unless a protocol-approved modification is documented, delivery at 10 Hz with 3-second trains, 15-second inter-train intervals, 60 trains and 1,800 pulses, adherence to the protocol schedule window, and documentation of session completion or any interruption or issue. Higher percentages indicate greater adherence to the Deep TMS delivery protocol.
Time frame: From the first active Deep TMS session through the end of treatment (Week 6)
Percentage of Participants Experiencing at Least One Deep TMS Device or Delivery Technical Issue
A participant will be counted as having a technical issue if at least one predefined Deep TMS device or delivery problem is documented during the treatment period. Examples include a console error, cooling fault, positioning-arm or helmet/coil fit issue, failed stimulation test, software or diagnostic alert, or an interruption or alarm during stimulation. The outcome will be summarized as the percentage of participants experiencing at least one such issue. Lower percentages indicate fewer technical or delivery problems.
Time frame: From the first Deep TMS session (Week 1) through the end of treatment (Week 6)
Percentage of Approached Individuals Who Consent to Participate (Consent Conversion Rate)
Consent conversion rate will be calculated as the number of individuals who provide informed consent divided by the number of individuals successfully approached or invited to participate in the study, multiplied by 100. Individuals who are not successfully approached will not be included in the denominator. Higher percentages indicate greater recruitment reach into the target population.
Time frame: From first participant screening through the end of accrual, approximately 12 months.
Percentage of Participants Experiencing at Least One Active Deep TMS Session-Related Adverse Effect
Participants will be counted as having a treatment-related adverse effect if they experience at least one adverse effect associated with an active Deep TMS study session during the treatment period, as assessed and documented by the study team. Adverse effects may include headache, scalp discomfort, facial or jaw twitching, dizziness, tinnitus, or mood changes. The outcome will be summarized as the percentage of participants experiencing at least one active Deep TMS session-related adverse effect.
Time frame: From the first active Deep TMS session (Week 1) through the end of treatment (Week 6)
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