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New study tests if office-based methadone keeps more people in opioid addiction treatment than buprenorphine

NCT ID NCT06323824

Disease control Sponsor: Yale University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 15, 2026 · Updated 2 times

Summary

This study compares two medications—methadone and buprenorphine—given in a doctor's office to treat opioid use disorder. Researchers want to see which one helps people stay in treatment longer over 168 days. About 600 adults starting a new treatment episode will take part. The goal is to find better ways to manage opioid addiction and keep people engaged in care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 600 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2024

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 99 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

opiate dependence

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Opioid use disorder

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    6 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hennepin Healthcare Addiction Medicine

    RECRUITING

    Minneapolis, Minnesota, 55415, United States

    Contact Email: •••••@•••••

  • Highland Hospital Bridge Clinic at Alameda Health System

    RECRUITING

    Oakland, California, 94602, United States

  • Marshall University Division of Addiction Sciences P.R.O.A.C.T

    RECRUITING

    Huntington, West Virginia, 25703, United States

  • Officed Based Addiction Treatment Program, Boston Medical Center

    RECRUITING

    Boston, Massachusetts, 02118, United States

  • Outpatient Buprenorphine Induction Clinic, University of California, San Francisco

    RECRUITING

    San Francisco, California, 94103, United States

  • Rapid Start Clinic, Kaiser Permanente Colorado

    RECRUITING

    Denver, Colorado, 80205, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.