Using brain scans and magnetic stimulation to help people quit opioids
The Development and Validation of Neural Targets in Opioid Use Disorder
This study is testing if brain scans can help predict how well people with opioid use disorder will do in quitting opioids when they start treatment with buprenorphine, and if adding a special brain stimulation can make the treatment work better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Duke University Academic / other |
| Locations | 1 site (Durham, North Carolina) |
| Trial ID | NCT06585709 on ClinicalTrials.gov |
What this trial studies
This research involves 80 participants with opioid use disorder who are beginning treatment with buprenorphine and aiming to quit opioids. The study aims to determine if an MRI brain marker can predict success in quitting opioids and whether repetitive Transcranial Magnetic Stimulation (rTMS) enhances the effectiveness of buprenorphine compared to a placebo. Participants will undergo MRI scans and receive either real or sham rTMS treatment over a period of 12 weeks, with weekly follow-ups to assess their progress.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who meet the criteria for moderate or severe opioid use disorder and are starting buprenorphine treatment.
Not a fit: Patients with alcohol or sedative/hypnotic use disorders, psychotic disorders, or other significant mental health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new method to predict and enhance treatment outcomes for individuals with opioid use disorder.
How similar studies have performed: Other studies have explored the use of rTMS in addiction treatment, but the specific combination of MRI markers and rTMS for opioid use disorder is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Durham, North Carolina
- Duke University — Durham, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Gregory Sahlem — Duke University
- Study coordinator: Gregory Sahlem
- Email: quitopioids@duke.edu
- Phone: (984) 340-0761
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.