OUD (Opioid Use Disorder) Target Trial

Description

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.

Conditions

Opioid Use Disorder

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Study Overview

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Study Details

Study overview

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.

The Development and Validation of Neural Targets in Opioid Use Disorder

OUD (Opioid Use Disorder) Target Trial

Condition
Opioid Use Disorder
Intervention / Treatment

-

Contacts and Locations

Durham

Duke University, Durham, North Carolina, United States, 27705

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Duke University,

Gregory Sahlem, PRINCIPAL_INVESTIGATOR, Duke University

Study Record Dates

2026-10-31