Office-based Methadone Versus Buprenorphine to Address Retention in Medication for Opioid Use Disorder Treatment. (NCT06323824)
🩺 Plain-English Summary (8th-Grade Level)
The purpose of this clinical trial is to compare the effectiveness of office-based methadone with pharmacy administration and/or dispensing to office-based buprenorphine for the treatment of opioid use disorder. This study will also examine factors influencing the implementation of office-based methadone.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (3 items) and avoid the listed exclusions (12 items).
Location: Highland Hospital Bridge Clinic at Alameda Health System — Oakland, California
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (6 Sites)
- Highland Hospital Bridge Clinic at Alameda Health System — Oakland, California
- Outpatient Buprenorphine Induction Clinic, University of California, San Francisco — San Francisco, California
- Rapid Start Clinic, Kaiser Permanente Colorado — Denver, Colorado
- Officed Based Addiction Treatment Program, Boston Medical Center — Boston, Massachusetts
- Hennepin Healthcare Addiction Medicine — Minneapolis, Minnesota
- Marshall University Division of Addiction Sciences P.R.O.A.C.T — Huntington, West Virginia
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.