Office-based Methadone Versus Buprenorphine to Address Retention in Medication for Opioid Use Disorder Treatment.
- Registration Number
- NCT06323824
- Lead Sponsor
- Yale University
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 600
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Office-based buprenorphine (BUP) Buprenorphine (BUP) 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). Office-based methadone Methadone 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).
- Primary Outcome Measures
Name Time Method 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. up to Day 168 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) or the electronic medical record (EMR).
- Secondary Outcome Measures
Name Time Method Number of days of self-reported non-prescribed benzodiazepine use per month. up to Day 168 The Timeline Followback instrument collects self-reported drug and alcohol use.
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 The MOUD Calendar Based Recall (Self-Report) form is used to collect self-reported prescribed medications for OUD.
Number of days of self-reported non-prescribed stimulant use per month. up to Day 168 The Timeline Followback instrument collects self-reported drug and alcohol use.
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 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.Number of days prescribed any FDA-approved MOUD formulation during the 168 days post-randomization. up to Day 168 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) or the electronic medical record (EMR).
Number of days of self-reported non-prescribed opioid use per month. up to Day 168 The Opioid Use Calendar Based Recall instrument is used to collect self-reported non-prescribed opioid use.
Urine toxicology up to Day 168 Number of monthly urines negative for non-prescribed opioids during the 168 days post-randomization. Non-prescribed opioids will be determined using the Opioid Use Calendar Based Recall self-report.
Participant satisfaction with MOUD up to Day 168 Proportion of RCT participants who report at the assessment scheduled to be collected on day 28 that the medication they received was at least "Somewhat helpful" on the Satisfaction with MOUD Provider Scale instrument.
Total number of self-reported overdose events per total number of participant days at risk. up to Day 168 The Overdose Calendar Recall instrument collects overdose events.
Total number of self-reported injection drug use related events per total number of participant days at risk. Up to Day 168 Assessment of Infectious or Other Complications of Injection Drug Use assess for self-report of skin or soft-tissue infections, osteoarticular infections (septic arthritis, osteomyelitis, epidural abscess), endovascular infections including endocarditis, or new injection-related viral infections.
Pain measured using PEG-3: "Pain average," "interference with Enjoyment of life," and "interference with General activity." Up to Day 168 Mean scores on the PEG-3 screening instrument over time. Total score range is 0-10; the highest being the worse pain.
Number of self-reported days with acute care utilization (ED or hospitalization) events during the 168 days post-randomization per month. Up to Day 168 The Health Services Utilization instrument is a brief, structured interview regarding health care utilization (inpatient and outpatient) collecting information on the type and amount of services received. This includes ED visits, hospitalizations, primary medical care visits (excluding those for BUP treatment) and self-help sources of support (e.g., NA). Also assessed are receipt of formal and informal addiction and mental health treatment services RCT participants might have received outside the study interventions.
Trial Locations
- Locations (6)
Highland Hospital Bridge Clinic at Alameda Health System
🇺🇸Oakland, California, United States
Marshall University Division of Addiction Sciences P.R.O.A.C.T
🇺🇸Huntington, West Virginia, United States
Officed Based Addiction Treatment Program, Boston Medical Center
🇺🇸Boston, Massachusetts, United States
Hennepin Healthcare Addiction Medicine
🇺🇸Minneapolis, Minnesota, United States
Outpatient Buprenorphine Induction Clinic, University of California, San Francisco
🇺🇸San Francisco, California, United States
Rapid Start Clinic, Kaiser Permanente Colorado
🇺🇸Denver, Colorado, United States