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 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.
Eligibility criteria
Qualifiers
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 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 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
Treatments tested in this trial
- Deep TMS System With H4 Coil
Treatment groups
12 Participants
are divided into 1 treatment groupSponsors and collaborators
Payel Roy
Lead sponsor
University of Pittsburgh
Sponsor institution
Source ClinicalTrials.gov