RECRUITING Phase 4 ClinicalTrials.gov

Office-based Methadone Versus Buprenorphine to Address Retention in Medication for Opioid Use Disorder Treatment.

Sponsor: Yale University • ClinicalTrials.gov ID: NCT06323824

Registry updated: 2026-09-14

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Description

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.

Interventions

Methadone (Drug)
Drug: Methadone Possible formulations: 10 and 50 mg tablets
Buprenorphine (BUP) (Drug)
Drug: Buprenorphine (BUP) Possible formulations: A. Buprenorphine, 225 mcg to 24 mg, 225 mcg to 32 mg per day, B. Buprenorphine (Extended release), 300 mg q 28 days (Sublocade), 100 mg q 28 days (Sublocade), 8 mg q 7 days (Brixadi), 16 mg q 7 days (Brixadi), 24 mg q 7 days (Brixadi), 32 mg q 7 days (Brixadi), 64 mg q 28 days (Brixadi), 96 mg q 28 days (Brixadi), 128 mg q 28 days (Brixadi),

Eligibility 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.

Conditions

Opioid Use Disorder

Locations

Highland Hospital Bridge Clinic at Alameda Health System — Oakland, California, United States
Outpatient Buprenorphine Induction Clinic, University of California, San Francisco — San Francisco, California, United States
Rapid Start Clinic, Kaiser Permanente Colorado — Denver, Colorado, United States
Officed Based Addiction Treatment Program, Boston Medical Center — Boston, Massachusetts, United States
Hennepin Healthcare Addiction Medicine — Minneapolis, Minnesota, United States
Marshall University Division of Addiction Sciences P.R.O.A.C.T — Huntington, West Virginia, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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