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

Recruiting now · Phase 4

Conditions studied: Opioid Use Disorder

In brief

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.

Key facts

Study ID

NCT06323824

Run by

Yale University

People needed

600

Starts

2024-06-04

Expected to finish

2028-12-01

Last updated by the study team

2026-05-05

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 it is running

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

Full record on ClinicalTrials.gov

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