Comparing office-based methadone and buprenorphine for treating opioid use disorder

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.