Deep Transcranial Magnetic Stimulation for Tobacco Cessation in Adults With Opioid Use Disorder
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22-70
SponsorPayel Roy
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Deep TMS System With H4 Coil
DeviceActive 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.
Treatment groups
12 Participants
are divided into 1 treatment groupGroup A: Active Deep TMSExperimental treatment 1 intervention
Trial outcomes
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 10Secondary 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 103
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)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-up2
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-up3
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-upSponsors and contacts
Click on the lead sponsor to view all of their trials.
Payel Roy
Lead sponsor
University of Pittsburgh
Sponsor institution
Source ClinicalTrials.gov
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