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

Phase 4RecruitingNCT06323824

Yale University600 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

600

Conditions

Opioid Use Disorder

Interventions

MethadoneDRUG

Drug: Methadone Possible formulations: 10 and 50 mg tablets

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)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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.

Locations (6)

Highland Hospital Bridge Clinic at Alameda Health System

Oakland, California, United States

RECRUITING

Outpatient Buprenorphine Induction Clinic, University of California, San Francisco

San Francisco, California, United States

RECRUITING

Rapid Start Clinic, Kaiser Permanente Colorado

Outcomes

Primary Outcomes

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).

Time frame: up to Day 168

Secondary Outcomes

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.

The MOUD Calendar Based Recall (Self-Report) form is used to collect self-reported prescribed medications for OUD.

Time frame: 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.

This information will be obtained from one or more of the following: Health Services Utilization instrument, a brief structured interview regarding health care utilization (inpatient and outpatient) collecting information on the type and amount of services received, Timeline Followback Medications, MOUD Calendar Based Recall, and Treatment Dates instruments.

Time frame: up to Day 168

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

Time frame: up to Day 168

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

The Opioid Use Calendar Based Recall instrument is used to collect self-reported non-prescribed opioid use.

Central Contacts

Jessica Research Associate

CONTACT

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

Melissa Gordon

CONTACT

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

Data from ClinicalTrials.gov

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