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

NCT06323824 | Recruiting Phase 4 DMC FDA Drug

• 3 other identifiers: 2000033271CTN-01315UG1DA015831-21
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 6

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

Keywords

Opioid Use Disorder; Methadone; Buprenorphine

Outcome Measures

Primary Outcomes (1)

• 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.

  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).

  up to Day 168

Secondary Outcomes (12)

• Number of self-reported days in any FDA-approved formulation of MOUD treatment (e.g., buprenorphine, methadone or naltrexone) during the 168 days post-randomization.

  up to Day 168

• Number of self-reported days in formal OUD treatment, according to American Society of Addiction Medicine (ASAM) levels of care 1-4, during the 168 days post-randomization.

  up to Day 168

• Number of days prescribed any FDA-approved MOUD formulation during the 168 days post-randomization.

  up to Day 168

• Number of days of self-reported non-prescribed opioid use per month.

  up to Day 168

• Number of days of self-reported non-prescribed stimulant use per month.

  up to Day 168

Other Outcomes (11)

• Retention in office-based methadone treatment

  Starting at day 168 post enrollment up to 2years

• Percentage of days covered of self-reported pharmacy dispensed methadone treatment

  starting at day 168 post enrollment up to 2 years

• Total number of self-reported overdose events

  Starting at day 168 post enrollment up to 2years

Study Arms (2)

Office-based methadone

EXPERIMENTAL

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).

Drug: Methadone

Office-based buprenorphine (BUP)

ACTIVE COMPARATOR

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).

Drug: Buprenorphine (BUP)

Interventions

Methadone DRUG

Drug: Methadone Possible formulations: 10 and 50 mg tablets

Office-based methadone

Buprenorphine (BUP) DRUG

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)

Office-based buprenorphine (BUP)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yale University: lead
• National Institutes of Health (NIH): collaborator
• National Institute on Drug Abuse (NIDA): collaborator
• The Emmes Company, LLC: collaborator
• University of California, San Francisco: collaborator
• Boston Medical Center (BMC): collaborator
• Hennepin Healthcare Research Institute: collaborator
• Alameda Health System: collaborator
• Marshall Health: collaborator
• Kaiser Permanente: collaborator

Study Sites (6)

Highland Hospital Bridge Clinic at Alameda Health System

Oakland, California, 94602, United States

RECRUITING

Outpatient Buprenorphine Induction Clinic, University of California, San Francisco

San Francisco, California, 94103, United States

RECRUITING

Rapid Start Clinic, Kaiser Permanente Colorado

Denver, Colorado, 80205, United States

RECRUITING

Officed Based Addiction Treatment Program, Boston Medical Center

Boston, Massachusetts, 02118, United States

RECRUITING

Hennepin Healthcare Addiction Medicine

Minneapolis, Minnesota, 55415, United States

RECRUITING

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

Huntington, West Virginia, 25703, United States

RECRUITING

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Methadone; Buprenorphine

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Ketones; Organic Chemicals; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• David Fiellin, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica Research Associate

CONTACT

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

Melissa Gordon

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The comparative effectiveness of two strategies to address retention in medication for opioid use disorder (MOUD) treatment will be tested over a 168-day period. Behavioral treatments offered to patients are designed to be similar across the two medication conditions. Office-based methadone where the clinician prescribes methadone and oral methadone is administered and/or dispensed at a pharmacy. Providers and Randomized Control Trial (RCT) participants will have flexibility to use behavioral and pharmacological services as clinically indicated. Office-based buprenorphine (BUP) where the clinician prescribes BUP formulations that are dispensed at a pharmacy or administered in the office (e.g., extended-release formulations). Providers and RCT participants will have flexibility to use behavioral and pharmacological services as clinically indicated.

Study Record Dates

• First Submitted: March 13, 2023
• First Posted: March 21, 2024
• Study Start: June 4, 2024
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data sets will be available after (1) the primary paper has been accepted for publication, or (2) the data is locked for more than 18 months, whichever comes first.
• Access Criteria: Public

Locations

US (6)