| NCT ID | NCT06585709 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Duke University |
| Condition | Opioid Use Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2024-12-31 |
| Primary Completion | 2026-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2024-12-31 with a primary completion date of 2026-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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
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.
Contact & Investigator
Gregory Sahlem
PRINCIPAL INVESTIGATOR
Duke University
Frequently Asked Questions
Who can join the NCT06585709 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Opioid Use Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06585709 currently recruiting?
Yes, NCT06585709 is actively recruiting participants. Contact the research team at quitopioids@duke.edu for enrollment information.
Where is the NCT06585709 trial being conducted?
This trial is being conducted at Durham, United States.
Who is sponsoring the NCT06585709 clinical trial?
NCT06585709 is sponsored by Duke University. The principal investigator is Gregory Sahlem at Duke University. The trial plans to enroll 80 participants.