OUD (Opioid Use Disorder) Target Trial
- Conditions
- Opioid Use Disorder
- Interventions
- Device: Active repetitive Transcranial Magnetic Stimulation (rTMS)Device: Sham repetitive Transcranial Magnetic Stimulation (rTMS)
- Registration Number
- NCT06585709
- Lead Sponsor
- Duke University
- Brief Summary
In this research study the investigators will work with 80-participants with opioid use disorder who are starting treatment with the medication buprenorphine and are trying to quit using opioids.
The investigators are trying to learn two things:
1. Can an MRI brain marker be used to predict which participants will be successful in quitting opioids with buprenorphine?
2. Does adjunctive treatment with repetitive Transcranial Magnetic Stimulation (rTMS) help people quit using opioids more than a sham (placebo) version of rTMS?
In order to complete the study the investigators will ask participants to:
* Complete an MRI within 5-days of starting buprenorphine and again after they are on a full stable dose 1-3 weeks later.
* Undergo study-treatment with 50-sessions of either real or placebo rTMS in as little as 1-week (10-sessions-per-day for five days) or as long as over 6-weeks.
* Meet with the investigators once per week over the following 12-weeks to see if the participants have been able to quit using opioids over that time.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 80
- Age 18 or older; all genders included.
- Intellectual level sufficient to provide informed consent and accurately complete assessment instruments (English speaking/writing).
- Meet DSM-5 criteria for moderate or severe OUD. Individuals may also meet criteria for another substance use disorder (with the exception of alcohol or sedative/hypnotic); but must identify opioids as their primary substance.
- Starting buprenorphine and planning on opioid abstinence
- Pregnant, breast-feeding, or planning on getting pregnant.
- Alcohol or sedative/hypnotic use disorders (seizure risk).
- History of/or current psychotic disorder (e.g. schizophrenia).
- Current or lifetime bipolar disorder.
- Unstable Axis-I condition requiring starting a new medication.
- Active suicidal ideation / suicide attempt within 90 days.
- History of/or current dementia or other cognitive impairment.
- Contraindications to receiving rTMS or undergoing MRI (implanted ferromagnetic metal, history of or high risk of seizure, implanted device).
- Unstable general medical conditions.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Active rTMS Active repetitive Transcranial Magnetic Stimulation (rTMS) A total of 50-sessions of standard iTBS (1800 pulses) will be delivered. rTMS-sessions will be ideally administered over 1-week (10-sessions-per-day, 50-minutes inter-session-interval, 5-days), but there will be flexibility in the delivery paradigm so long as participants complete all sessions of rTMS within 6 weeks and come in at least twice per week. Sham rTMS Sham repetitive Transcranial Magnetic Stimulation (rTMS) Double-blind sham-rTMS in an identical fashion to the active-rTMS condition will be delivered.
- Primary Outcome Measures
Name Time Method Number of participants with Relapse Free survival Up to 12 weeks The number of participants who have not met relapse criteria in the 12-week follow-up phase. Relapse is defined as a) any opioid use in 4 consecutive weeks, or b) any opioid use on 7 consecutive days.
- Secondary Outcome Measures
Name Time Method Weeks of opioid abstinance 12-weeks Number of weeks in the 12-week follow-up period that the participant is abstinent from opioids based on self-report and a negative urine drug test
Trial Locations
- Locations (1)
Duke University
🇺🇸Durham, North Carolina, United States