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NCT06585709NARecruiting

OUD (Opioid Use Disorder) Target Trial

Duke University

Start Date

12/31/2024

Completion Date

10/31/2026

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 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 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.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

DEVICE

Active repetitive Transcranial Magnetic Stimulation (rTMS)

DEVICE

Sham repetitive Transcranial Magnetic Stimulation (rTMS)

DIAGNOSTIC_TEST

High Ventral Striatal Reactivity

DIAGNOSTIC_TEST

Low Ventral Striatal Reactivity

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Conditions

Opioid Use Disorder

Locations

Duke University

Durham, North Carolina 27705

United States