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OUD (Opioid Use Disorder) Target Trial

The Development and Validation of Neural Targets in Opioid Use Disorder

Who can join

Ages 18 and older · All sexes

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.

About the study

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.

What is being tested

• Active repetitive Transcranial Magnetic Stimulation (rTMS) (device)
• Sham repetitive Transcranial Magnetic Stimulation (rTMS) (device)
• High Ventral Striatal Reactivity (diagnostic test)
• Low Ventral Striatal Reactivity (diagnostic test)

Sponsor: Duke University · Participants: 80 · Started: Dec 31, 2024

Contact the study team

• Gregory Sahlem · Phone: (984) 340-0761

Official record on ClinicalTrials.gov — NCT06585709

Locations in the U.S.

Conditions

• Opioid Overdose

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.