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

Официальное название

Office-based Methadone Versus Buprenorphine to Address Retention in Medication for Opioid Use Disorder Treatment - A Pragmatic Hybrid Effectiveness/Implementation Trial

Обзор

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.

Подробное описание

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.

An ancillary extended study was added to this trial in January of 2026. A sub-set of current participants that were receiving office based methadone as of day 168 of the parent study will continue to be followed for other pre-specified outcomes.

Вмешательства

• Препарат Methadone
  Drug: Methadone Possible formulations: 10 and 50 mg tablets
• Препарат 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)

Первичные конечные точки

• 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. [Срок оценки: up to Day 168]

Вторичные конечные точки (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. [Срок оценки: 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. [Срок оценки: up to Day 168]
• Number of days prescribed any FDA-approved MOUD formulation during the 168 days post-randomization. [Срок оценки: up to Day 168]
• Number of days of self-reported non-prescribed opioid use per month. [Срок оценки: up to Day 168]
• Number of days of self-reported non-prescribed stimulant use per month. [Срок оценки: up to Day 168]
• Number of days of self-reported non-prescribed benzodiazepine use per month. [Срок оценки: up to Day 168]
• Urine toxicology [Срок оценки: up to Day 168]
• Participant satisfaction with MOUD [Срок оценки: up to Day 168]
• Total number of self-reported overdose events per total number of participant days at risk. [Срок оценки: up to Day 168]
• Total number of self-reported injection drug use related events per total number of participant days at risk. [Срок оценки: Up to Day 168]
• Pain measured using PEG-3: "Pain average," "interference with Enjoyment of life," and "interference with General activity." [Срок оценки: Up to Day 168]
• Number of self-reported days with acute care utilization (ED or hospitalization) events during the 168 days post-randomization per month. [Срок оценки: Up to Day 168]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 6 центров

• Highland Hospital Bridge Clinic at Alameda Health System — Oakland
• Outpatient Buprenorphine Induction Clinic, University of California, San Francisco — San Francisco
• Rapid Start Clinic, Kaiser Permanente Colorado — Denver
• Officed Based Addiction Treatment Program, Boston Medical Center — Boston
• Hennepin Healthcare Addiction Medicine — Minneapolis
• Marshall University Division of Addiction Sciences P.R.O.A.C.T — Huntington

Идентификаторы

NCT: NCT06323824 · 2000033271 · CTN-0131 · 5UG1DA015831-21

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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