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

Last updated: August 26, 2024
Sponsor: Yale University
Overall Status: Active - Recruiting

Phase

4

Condition

Opioid Use Disorder

Stimulant Use Disorder

Treatment

Buprenorphine (BUP)

Methadone

Clinical Study ID

NCT06323824
2000033271
CTN-0131
5UG1DA015831-21
  • Ages 18-99
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 or unwilling to provide reliable locator information including 2 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.

Study Design

Total Participants: 600
Treatment Group(s): 2
Primary Treatment: Buprenorphine (BUP)
Phase: 4
Study Start date:
June 04, 2024
Estimated Completion Date:
May 31, 2029

Study Description

This study is a randomized, pragmatic hybrid type 1 effectiveness/implementation multisite (approximately 6 sites) trial to determine whether office-based methadone with pharmacy administration and/or dispensing or buprenorphine (BUP) results in greater treatment retention in approximately 600 patients with opioid use disorder (OUD). This trial will also identify implementation barriers, facilitators and acceptability at the patient, provider and health-systems level for office-based methadone with pharmacy administration and/or dispensing.

Connect with a study center

  • Highland Hospital Bridge Clinic at Alameda Health System

    Oakland, California 94602
    United States

    Active - Recruiting

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

    San Francisco, California 94103
    United States

    Active - Recruiting

  • Rapid Start Clinic, Kaiser Permanente Colorado

    Denver, Colorado 80205
    United States

    Active - Recruiting

  • Officed Based Addiction Treatment Program, Boston Medical Center

    Boston, Massachusetts 02118
    United States

    Active - Recruiting

  • Hennepin Healthcare Addiction Medicine

    Minneapolis, Minnesota 55415
    United States

    Active - Recruiting

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

    Huntington, West Virginia 25703
    United States

    Site Not Available

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