Comparing office-based methadone and buprenorphine for treating opioid use disorder
Office-based Methadone Versus Buprenorphine to Address Retention in Medication for Opioid Use Disorder Treatment - A Pragmatic Hybrid Effectiveness/Implementation Trial
This study is testing whether getting methadone or buprenorphine in a doctor's office helps people with opioid use disorder stay in treatment longer.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Yale University Academic / other |
| Locations | 6 sites (Oakland, California and 5 other locations) |
| Trial ID | NCT06323824 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of office-based methadone with pharmacy administration to office-based buprenorphine in retaining patients undergoing treatment for opioid use disorder. It is a randomized, pragmatic hybrid effectiveness and implementation trial conducted across approximately six sites, involving around 600 patients. The study will also explore barriers and facilitators to implementing office-based methadone treatment from the perspectives of patients, providers, and health systems.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who meet DSM-5 criteria for opioid use disorder and are starting a new medication for opioid use disorder treatment.
Not a fit: Patients who have recently been prescribed or administered more than 72 hours of medication for opioid use disorder or those with severe comorbid conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve retention rates in treatment for patients with opioid use disorder.
How similar studies have performed: Previous studies have shown varying success with similar approaches, but this specific comparison of office-based methadone and buprenorphine is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria * 18 years of age or older; * Meet Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for OUD; * Are initiating a new MOUD treatment episode Exclusion Criteria * Have been prescribed (and ingested) or been administered more than 72 hours of MOUD in the 7 days prior to randomization as a "bridge" to the new OUD treatment episode. Such MOUD may include prescribed (and ingested) or administered medically managed withdrawal (aka detoxification). * Known contraindication to methadone or BUP * Unwilling to pursue or continue pre-natal care or pregnancy counseling if determined pregnant by urine human chorionic gonadotropin (hCG) testing at the screening assessment * Be actively suicidal or severely cognitively impaired (e.g., dementia, untreated psychosis) precluding informed consent as determined by site clinician * Current severe comorbid substance use disorder requiring residential or inpatient treatment services as determined by site clinician * Be unable to provide locator information including one or more contacts in addition to themselves * Be unwilling to follow study procedures (e.g., unwilling to receive treatment from site clinician, use the study pharmacy, unwilling to be randomized to BUP or methadone, or will be unavailable for the follow-up assessments) including allowing the researchers to access their record in the EMR and state's prescription drug monitoring program * Have previously enrolled in CTN-0131 * Currently enrolled in another research study which will conflict with study procedures * Are currently in jail, prison or other overnight facility as required by a court of law or have pending legal action that could prevent participation in study activities * Unable to conduct research assessments in English as determined by Site PI or their designee.
Where this trial is running
Oakland, California and 5 other locations
- Highland Hospital Bridge Clinic at Alameda Health System — Oakland, California, United States (Recruiting)
- Outpatient Buprenorphine Induction Clinic, University of California, San Francisco — San Francisco, California, United States (Recruiting)
- Rapid Start Clinic, Kaiser Permanente Colorado — Denver, Colorado, United States (Recruiting)
- Officed Based Addiction Treatment Program, Boston Medical Center — Boston, Massachusetts, United States (Recruiting)
- Hennepin Healthcare Addiction Medicine — Minneapolis, Minnesota, United States (Recruiting)
- Marshall University Division of Addiction Sciences P.R.O.A.C.T — Huntington, West Virginia, United States (Recruiting)
Study contacts
- Principal investigator: David Fiellin, MD — Yale University
- Study coordinator: Jessica Research Associate
- Email: j.mckenzie@yale.edu
- Phone: 203-785-6821
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.