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OUD (Opioid Use Disorder) Target Trial

RecruitingNAAges 18 Years - anyAllDuke University
NCT06585709 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 30-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

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Age 18 or older; all genders included. 2. Intellectual level sufficient to provide informed consent and accurately complete assessment instruments (English speaking/writing). 3. 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. 4. Starting buprenorphine and planning on opioid abstinence Exclusion Criteria: 1. Pregnant, breast-feeding, or planning on getting pregnant. 2. Alcohol or sedative/hypnotic use disorders (seizure risk). 3. History of/or current psychotic disorder (e.g. schizophrenia). 4. Current or lifetime bipolar disorder. 5. Unstable Axis-I condition requiring starting a new medication. 6. Active suicidal ideation / suicide attempt within 90 days. 7. History of/or current dementia or other cognitive impairment. 8. Contraindications to receiving rTMS or undergoing MRI (implanted ferromagnetic metal, history of or high risk of seizure, implanted device). 9. Unstable general medical conditions.
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What it tests

  • Active repetitive Transcranial Magnetic Stimulation (rTMS)
  • Sham repetitive Transcranial Magnetic Stimulation (rTMS)
  • High Ventral Striatal Reactivity
  • Low Ventral Striatal Reactivity
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Where

1 site
Duke University
Durham, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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