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Not yet recruitingNCT07770555Updated Aug 27, 2026

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

An interventional study of Deep TMS System With H4 Coil in Opioid Use Disorder and Tobacco Use Disorder, sponsored by Payel Roy. Not yet recruiting at 2 sites in United States. Open to participants aged 22 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-08-27.

Sponsored by Payel Roy · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Not applicable
Ages
22 Years to 70 Years
Sex
All
01

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 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.

02

Conditions studied

  • Opioid Use Disorder
  • Tobacco Use Disorder

Keywords

  • Deep Transcranial Magnetic Stimulation
  • Transcranial Magnetic Stimulation
  • Smoking Cessation
  • Cigarette Smoking
  • Neuromodulation
  • H4 Coil
  • Insular Cortex
  • Prefrontal Cortex
  • Tobacco Craving
  • Opioid Craving
  • Tobacco Cue Reactivity
  • Medications for Opioid Use Disorder
  • Buprenorphine
  • Methadone
03

Who can participate

Ages eligible
22 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Male or female participants, 22-70 years old.
  • Chronic, heavy smoker (>10 cigarettes/day for >1 year) with no continuous abstinence period >3 months in the past 12 months (self-report), and baseline smoking confirmed by either (a) cotinine-positive urine or (b) clinical documentation of current smoking when cotinine interpretation is not reliable due to nicotine replacement or other nicotine product use reported at baseline.
  • Motivated to quit smoking, defined as a Motivation To Stop Scale (MTSS) score ≥6 at baseline (i.e., endorsing intention to quit within the next 3 months or within the next month).
  • Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnostic criteria for moderate or severe Opioid Use Disorder (OUD), with diagnosis confirmed by the study investigator through clinical interview study assessment.
  • Meet DSM-5 diagnostic criteria for Severe Tobacco Use Disorder, confirmed by the study investigator through clinical interview study assessment.
  • Have received buprenorphine or methadone consistently for the last 3 months (≥80% proportion of days covered or equivalent documentation for clinic-administered dosing, such as opioid treatment program dosing records or medication administration records demonstrating consistent dosing over the same 3-month period).
  • No self-reported illicit fentanyl use in the past 30 days AND evidence of fentanyl-negative urine toxicology, defined as either (a) a documented fentanyl-negative urine drug screen in the medical record within 7 days prior to consent or (b) a fentanyl-negative urine toxicology obtained at baseline screening.
  • Able to communicate fluently in English for accurate administration of assessments and safety monitoring.
  • For participants with the potential to become pregnant: pregnancy status must be confirmed after informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization and before study treatment. Participants must have either (a) a negative urine pregnancy test obtained by the study team at baseline after informed consent or (b) a documented negative serum or urine human chorionic gonadotropin (hCG) result from standard clinical care within 7 days prior to consent, reviewed or abstracted by the study team only after informed consent and HIPAA authorization.
  • At least one prior quit attempt in the past 12 months, defined as intentionally stopping smoking for ≥24 hours (≥1 day) because they were trying to quit, assessed by self-report at baseline screening.

Exclusion criteria

Exclusion Criteria:

  • History of seizure disorder, epilepsy, stroke, significant head trauma, or other clinically significant neurologic condition or structural brain lesion (e.g., tumor, vascular malformation, intracranial aneurysm/aneurysm repair, meningitis/encephalitis with neurologic sequelae).
  • Metallic, electronic, magnetically activated, or retained metal implants/devices that may contraindicate Deep TMS exposure, including but not limited to pacemaker/implantable cardioverter-defibrillator, cochlear or otologic implants, implanted hearing-aid anchors, deep brain stimulator, vagus nerve stimulator, aneurysm clip/coil, carotid/cerebral stent, ocular metallic implant/stent, cerebrospinal fluid shunt, intracardiac lines/wires, implanted pump, retained bullet/pellet/shrapnel, staples/sutures or metal hardware in or around the head/neck, skull/cervical fixation plates, titanium skull plates, magnetically activated dental implants, or facial tattoos/permanent makeup with metallic ink, as determined by the investigator.
  • Unstable or severe medical condition (e.g., uncontrolled cardiac, hepatic, renal, or metabolic disease) that increases risk from study participation, based on medical history review, medical record review, and investigator clinical judgment.
  • Current pregnancy, intention to become pregnant during the study period, or actively breastfeeding. For participants with the potential to become pregnant, a negative pregnancy test is required before initiating study treatment.
  • Active psychotic disorder, bipolar mania, or major depressive episode with psychotic features, as determined by the study investigator.
  • Severe cognitive impairment or neurocognitive disorder that limits the ability to provide informed consent or complete study procedures. Participants unable to complete consent teach-back will be excluded.
  • Acute intoxication or clinically significant opioid withdrawal at baseline screening, defined as a Clinical Opiate Withdrawal Scale (COWS) score ≥12.
  • Current or recent (within the past 30 days) use of any medication known to significantly lower the seizure threshold, including but not limited to bupropion, clozapine, olanzapine, clomipramine, amitriptyline, or tramadol, or other clinically significant use determined by the investigator to further lower seizure threshold.
  • Any lifetime history of electroconvulsive therapy (ECT) or repetitive transcranial magnetic stimulation (rTMS).
  • Frequent or severe migraine headaches, defined as ≥8 migraine days per month over the past 30 days, or migraine headaches that, in the investigator's clinical judgment, are expected to interfere with tolerating Deep TMS sessions.
  • Significant hearing loss that, in the investigator's judgment, would prevent safe participation despite use of hearing protection.
  • Participation in another interventional clinical trial within the last 30 days prior to informed consent.
  • First-degree family history of epilepsy or seizure disorder (biological parent, full sibling, or child).
  • History of recurrent syncope or unexplained fainting, including any episode with loss of consciousness or convulsive features, that has not been adequately evaluated/cleared or would increase risk with Deep TMS in the investigator's judgment.
  • Current prescribed benzodiazepine or anticonvulsant regimen that has not been stable for at least 4 weeks before consent, defined as any new start, discontinuation, dose increase or decrease, route/formulation change, change in scheduled dosing frequency, or, for as-needed medications, a change in prescribed instructions or clinically meaningful increase in frequency or amount used during the 4 weeks before consent, as determined by the investigator.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (estimated)

Study 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.

    Device: Deep TMS System With H4 Coil

Interventions

  • DeviceDeep 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 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.

    Also known as: BrainsWay Deep TMS System, BrainsWay H4 Coil, Deep TMS

05

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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

  3. 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.

  4. 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)

  5. 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)

  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)

  7. 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.

  8. 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)

Other outcomes

  1. Mean Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score

    Depression severity will be assessed using the clinician-rated 10-item Montgomery-Åsberg Depression Rating Scale (MADRS). The total score ranges from 0 to 60, with higher scores indicating greater depression severity. MADRS total scores will be summarized descriptively at each prespecified assessment time point.

    Time frame: Baseline (Week 0), end of Week 3, end of Week 6, and Week 10 follow-up

  2. Mean Patient Health Questionnaire-9 (PHQ-9) Total Score

    Depression severity will be assessed using the 9-item Patient Health Questionnaire-9 (PHQ-9). The total score ranges from 0 to 27, with higher scores indicating greater depression severity. PHQ-9 total scores will be summarized descriptively at each prespecified assessment time point.

    Time frame: Baseline (Week 0), end of Week 3, end of Week 6, and Week 10 follow-up

  3. Mean State-Trait Anxiety Inventory-State (STAI-S) Total Score

    State anxiety will be assessed using the 20-item State-Trait Anxiety Inventory-State (STAI-S), which measures how the participant feels "right now." The total score ranges from 20 to 80, with higher scores indicating greater state anxiety. STAI-S 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.

  4. Mean Generalized Anxiety Disorder-7 (GAD-7) Total Score

    Anxiety severity will be assessed using the 7-item Generalized Anxiety Disorder-7 (GAD-7), which asks about anxiety symptoms during the past 2 weeks. Each item is scored from 0 to 3, producing a total score ranging from 0 to 21. Higher scores indicate greater anxiety severity. GAD-7 total scores will be summarized descriptively at each prespecified assessment time point.

    Time frame: Baseline (Week 0), end of Week 3, end of Week 6, and Week 10 follow-up

  5. Mean Numeric Pain Rating Scale (NPRS) Score

    Current pain intensity will be assessed using an 11-point Numeric Pain Rating Scale (NPRS) ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores indicate greater pain intensity. NPRS 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.

  6. Mean Heart Rate Variability Measured by Root Mean Square of Successive Differences (RMSSD)

    Heart rate variability will be assessed during a 5-minute resting recording using a wrist-worn sensor and quantified using the root mean square of successive differences (RMSSD), reported in milliseconds. Higher RMSSD values indicate greater beat-to-beat heart rate variability. RMSSD 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 RMSSD values and post-session RMSSD values 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 RMSSD values 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.

  7. Mean Patient-Reported Outcomes Measurement Information System (PROMIS) Global Physical Health T-Score

    Global physical health will be assessed using the PROMIS Global Health Short Form (Global10). A Global Physical Health raw summary score will be calculated from the designated physical-health items and converted to a PROMIS Global Physical Health T-score using the PROMIS Global Health v1.2 conversion table. T-scores will be summarized descriptively at each prespecified assessment time point.

    Time frame: Baseline (Week 0), end of Week 3, end of Week 6, and Week 10 follow-up

  8. Mean PROMIS Global Mental Health T-Score

    Global mental health will be assessed using the PROMIS Global Health Short Form (Global10). A Global Mental Health raw summary score will be calculated from the designated mental-health items and converted to a PROMIS Global Mental Health T-score using the PROMIS Global Health v1.2 conversion table. T-scores will be summarized descriptively at each prespecified assessment time point.

    Time frame: Baseline (Week 0), end of Week 3, end of Week 6, and Week 10 follow-up

  9. Mean Change in Tobacco Craving After Cue Exposure (Cue Reactivity, B - A)

    Tobacco craving will be rated on a single-item scale from 0 to 10, where 0 indicates no craving or urge to smoke and 10 indicates the strongest craving or urge imaginable. Cue reactivity will be calculated as the craving rating after cue exposure and before Deep TMS (B) minus the craving rating before cue exposure (A). The resulting change score can range from -10 to 10. Positive values indicate an increase in tobacco craving following cue exposure, while negative values indicate a decrease. For reporting, each participant's B - A change scores will be averaged across sessions 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.

    Time frame: Acute treatment phase (Weeks 1-3) and maintenance treatment phase (Weeks 4-6), for sessions in which the tobacco cue procedure is performed.

  10. Mean Change in Tobacco Craving Immediately After Deep TMS Following Cue Exposure (C - B)

    Tobacco craving will be rated on a single-item scale from 0 to 10, where 0 indicates no craving or urge to smoke and 10 indicates the strongest craving or urge imaginable. Immediate Deep TMS-associated craving change will be calculated as the craving rating immediately after Deep TMS (C) minus the craving rating after cue exposure and before Deep TMS (B). The resulting change score can range from -10 to 10. Negative values indicate a reduction in cue-provoked tobacco craving immediately after Deep TMS, while positive values indicate an increase. For reporting, each participant's C - B change scores will be averaged across completed cue and Deep sessions 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.

    Time frame: Acute treatment phase (Weeks 1-3) and maintenance treatment phase (Weeks 4-6), for sessions in which the tobacco cue procedure and Deep TMS are completed

06

Study locations

2 sites
  • UPMC Presbyterian
    Pittsburgh, Pennsylvania 15213, United States
  • University of Pittsburgh Medical Center (UPMC) Mercy - Internal Medicine Recovery Engagement Program (IM-REP)
    Pittsburgh, Pennsylvania 15219, United States
07

References and documents

Individual participant data

Plan to share: No — No formal individual participant data sharing plan has been established for this pilot study. De-identified data may be considered for future sharing only if appropriate approvals, institutional requirements, and any necessary data use agreements are in place.

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07770555
Lead sponsor
Payel Roy
Responsible party
Payel Roy (Associate Professor of Medicine, University of Pittsburgh) — Sponsor-investigator
First posted
Aug 18, 2026
Start date
Jan 2027 (estimated)
Primary completion
Dec 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Aug 27, 2026

Study contacts

Payel J Roy, MD, MSc
Contact
roypj@upmc.edu
412-692-4473
Gagandeep Singh Shergill, B Pharm, MS
Contact
gas246@pitt.edu
937-831-8031
Payel J Roy, MD, MSc
principal investigator · University of Pittsburgh

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
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