Recruiting

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

Sponsor:

Yale University

Code:

NCT06323824

Conditions

Opioid Use Disorder

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Methadone

Buprenorphine (BUP)

Study Details

Brief 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.

Conditions

Opioid Use Disorder

Study ID

NCT06323824

Start date

Jun 4, 2024

Status verified date

Apr, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

600 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Office-based methadone

Under special Drug Enforcement Administration (DEA) exception, Clinician prescribes methadone and oral methadone is administered and/or dispensed at a pharmacy which also has an exception to do so. All randomized controlled trial (RCT) participants are offered additional behavioral treatments (e.g., individual, group, telehealth, phone-based).

active comparator: Office-based buprenorphine (BUP)

Clinician prescribes BUP formulations that are dispensed at a pharmacy or administered in the office (e.g., extended-release formulations). All RCT participants are offered additional behavioral treatments (e.g., individual, group, telehealth, phone-based).

Interventions

Methadone

Drug: Methadone

Possible formulations:

10 and 50 mg tablets

Buprenorphine (BUP)

Drug: Buprenorphine (BUP)

Possible formulations:

A. Buprenorphine 225 mcg to 24 mg 225 mcg to 32 mg per day

B. Buprenorphine (Extended release) 300 mg q 28 days (Sublocade) 100 mg q 28 days (Sublocade) 8 mg q 7 days (Brixadi) 16 mg q 7 days (Brixadi) 24 mg q 7 days (Brixadi) 32 mg q 7 days (Brixadi) 64 mg q 7 28 days (Brixadi) 96 mg q 7 28 days (Brixadi) 128 mg q 7 28 days (Brixadi)

Primary outcome measure

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. [ Time Frame: up to Day 168 ]

Central Contacts and Locations

Central contacts

Jessica Research Associate

203-785-6821 j.mckenzie@yale.edu

Melissa Gordon

203-937-3486 melissa.gordon@yale.edu

Locations

Highland Hospital Bridge Clinic at Alameda Health System

Recruiting

Oakland, California, United States, 94602

Contacts

Jhoselyn Pineda

(510)214-3649 emboss.ctn0131@gmail.com

Principal Investigator:

Monish Ullal, MD

Outpatient Buprenorphine Induction Clinic, University of California, San Francisco

Recruiting

San Francisco, California, United States, 94103

Contacts

Kristina Toma

415-254-0398 EMBOSS@ucsf.edu

Principal Investigator:

Paula Lum, MD

Rapid Start Clinic, Kaiser Permanente Colorado

Recruiting

Denver, Colorado, United States, 80205

Contacts

Jennifer Barrow

(303)-739-3666 EMBOSS@kp.org

Principal Investigator:

Ingrid Binswanger, MD

Officed Based Addiction Treatment Program, Boston Medical Center

Recruiting

Boston, Massachusetts, United States, 02118

Contacts

Emily Oot

857-283-7620 EMBOSS@bmc.org

Principal Investigator:

Zoe Weinstein, MD

Hennepin Healthcare Addiction Medicine

Recruiting

Minneapolis, Minnesota, United States, 55415

Contacts

Dat Nguyen

(763) 568-2785 EMBOSSstudy@bermancenter.org

Principal Investigator:

Gavin Bart, MD

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

Recruiting

Huntington, West Virginia, United States, 25703

Contacts

Brynn M Taylor

740-302-0845 taylor975@marshall.edu

Principal Investigator:

Zachary Hansen, MD

More Information

Sponsor

Yale University

Last update posted

May 5, 2026

Last verified

Apr, 2026

Keywords

Opioid Use Disorder
Methadone
Buprenorphine

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Yale University on 2026-05-05.