Clinical trial NCT06323824: Office-based Methadone Versus Buprenorphine to Address Retention in Medication for Opioid Use Disorder Treatment.
Official title: Office-based Methadone Versus Buprenorphine to Address Retention in Medication for Opioid Use Disorder Treatment - A Pragmatic Hybrid Effectiveness/Implementation Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Opioid Use Disorder
Keywords: Opioid Use Disorder
Methadone
Buprenorphine
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute on Drug Abuse (NIDA)
name: The Emmes Company, LLC
name: University of California, San Francisco
name: Boston Medical Center (BMC)
name: Hennepin Healthcare Research Institute
name: Alameda Health System
name: Marshall Health
name: Kaiser Permanente
First posted: 2024-03-21
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility 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 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.

Primary outcomes:
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.
timeFrame: up to Day 168
Secondary outcomes:
measure: 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.
timeFrame: up to Day 168
measure: 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.
timeFrame: up to Day 168
measure: Number of days prescribed any FDA-approved MOUD formulation during the 168 days post-randomization.
timeFrame: up to Day 168
measure: Number of days of self-reported non-prescribed opioid use per month.
timeFrame: up to Day 168
measure: Number of days of self-reported non-prescribed stimulant use per month.
timeFrame: up to Day 168
measure: Number of days of self-reported non-prescribed benzodiazepine use per month.
timeFrame: up to Day 168
measure: Urine toxicology
timeFrame: up to Day 168
measure: Participant satisfaction with MOUD
timeFrame: up to Day 168
measure: Total number of self-reported overdose events per total number of participant days at risk.
timeFrame: up to Day 168
measure: Total number of self-reported injection drug use related events per total number of participant days at risk.
timeFrame: Up to Day 168
measure: Pain measured using PEG-3: "Pain average," "interference with Enjoyment of life," and "interference with General activity."
timeFrame: Up to Day 168
measure: Number of self-reported days with acute care utilization (ED or hospitalization) events during the 168 days post-randomization per month.
timeFrame: Up to Day 168
Other outcomes:
Locations:
city: Oakland
country: United States
facility: Highland Hospital Bridge Clinic at Alameda Health System
state: California
city: San Francisco
country: United States
facility: Outpatient Buprenorphine Induction Clinic, University of California, San Francisco
state: California
city: Denver
country: United States
facility: Rapid Start Clinic, Kaiser Permanente Colorado
state: Colorado
city: Boston
country: United States
facility: Officed Based Addiction Treatment Program, Boston Medical Center
state: Massachusetts
city: Minneapolis
country: United States
facility: Hennepin Healthcare Addiction Medicine
state: Minnesota
city: Huntington
country: United States
facility: Marshall University Division of Addiction Sciences P.R.O.A.C.T
state: West Virginia
Study officials:
affiliation: Yale University
name: David Fiellin, MD
role: PRINCIPAL_INVESTIGATOR
References: