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

Yale University

Status and phase: Enrolling; Phase 4

Conditions: Opioid Use Disorder

Treatments: Drug: Methadone; Drug: Buprenorphine (BUP)

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT06323824

5UG1DA015831-21 (U.S. NIH Grant/Contract)

CTN-0131 (Other Identifier)

2000033271

Details and patient eligibility

About

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.

Full 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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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600 participants in 2 patient groups

Office-based methadone

Experimental group

Description:

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).

Treatment:

Drug: Methadone

Office-based buprenorphine (BUP)

Active Comparator group

Description:

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).

Treatment:

Drug: Buprenorphine (BUP)