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Comparing Methadone and Buprenorphine for Opioid Use Disorder

This study is comparing two common medications for opioid use disorder (OUD): methadone and buprenorphine. Researchers want to see which medication helps people stay in treatment longer when given in an office setting. You might be able to join if you are 18 or older, have been diagnosed with OUD, and are starting a new treatment. The study will measure how many days you stay on your assigned medication (methadone or buprenorphine) for up to 168 days. This trial is currently unclear on its recruitment status.

Study design
This is a randomized study, meaning you would be randomly assigned to receive either methadone or buprenorphine. Approximately 600 people are expected to participate across several sites.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 168 days after starting treatment. Some participants receiving office-based methadone may be followed for additional outcomes after this period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06323824

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

Recruiting
PHASE4Ages 18–99InterventionalTreatment
Yale University
~600 participants
Updated 2026-05-05 on ClinicalTrials.gov
What's tested:MethadoneBuprenorphine (BUP)

At a glance

Recruiting sites
6 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of days of continuous treatment with study site clinician-prescribed methadone or buprenorphine, as randomized, during the 168 days post-randomization among RCT participants.
Measured over up to Day 168

Conditions

Opioid Use Disorder

Explore related trials

Opioid Use Disorder

Where it's being run

6 sites across 5 states
California2
Colorado1
Massachusetts1
Minnesota1
West Virginia1

Study leadership

  • David Fiellin, MD · PRINCIPAL_INVESTIGATOR · Yale University

Who to contact

Jessica Research Associate
[email protected]
203-785-6821
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Number of days of continuous treatment with study site clinician-prescribed methadone or buprenorphine, as randomized, during the 168 days post-randomization among RCT participants.up to Day 168

    MOUD dispensed to the participant including medication, duration of prescription and daily dose prescribed data will be extracted from the state prescription drug monitoring program (PDMP) and the electronic medical record (EMR).