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. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
600
Drug: Methadone Possible formulations: 10 and 50 mg tablets
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 28 days (Brixadi), 96 mg q 28 days (Brixadi), 128 mg q 28 days (Brixadi),
Highland Hospital Bridge Clinic at Alameda Health System
Oakland, California, United States
RECRUITINGOutpatient Buprenorphine Induction Clinic, University of California, San Francisco
San Francisco, California, United States
RECRUITINGRapid Start Clinic, Kaiser Permanente Colorado
Number of days of continuous treatment with site clinician-prescribed methadone or buprenorphine, as randomized, during the 168 days post-randomization among RCT participants.
This measure is based on PDMP data for methadone and non-injectable buprenorphine and EMR data for injectable buprenorphine formulations
Time frame: up to Day 168
Number of self-reported continuous treatment days in any FDA-approved formulation of MOUD treatment during the 168 days post-randomization.
This measure is assessed using the MOUD Calendar Based Recall Recall Instruments.
Time frame: up to Day 168
Number of self-reported continuous treatment 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 measure is assessed using one or more of the following: The 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
Total number of days receiving any FDA-approved MOUD formulation during the 168 days post-randomization.
This measure is assessed using EMR (for injectable MOUD formulations) and PDMP data.
Time frame: up to Day 168
The longest duration of continuous treatment episode with MOUD, as randomized, during the 168 days post randomization.
This measure is based on PDMP and/or EMR data.
Time frame: up to Day 168
Total number of days receiving methadone or buprenorphine, during the 168 days post-randomization.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Denver, Colorado, United States
Officed Based Addiction Treatment Program, Boston Medical Center
Boston, Massachusetts, United States
RECRUITINGHennepin Healthcare Addiction Medicine
Minneapolis, Minnesota, United States
RECRUITINGMarshall University Division of Addiction Sciences P.R.O.A.C.T
Huntington, West Virginia, United States
RECRUITINGThis measure is assessed using EMR (for injectable MOUD formulations) and PDMP data.
Time frame: up to Day 168
Total number of days of self-reported non-prescribed opioid use during each 28-day assessment period.
This measure is assessed by the Opioid Use Calendar Based Recall instruments.
Time frame: up to Day 168
Total number of days of self-reported non-prescribed stimulant use during each 28-day assessment period.
This measure is assessed by the Timeline Followback instrument.
Time frame: up to Day 168
Total number of days of self-reported non-prescribed benzodiazepine use during each 28-day assessment period.
This measure is assessed by the Timeline Followback instrument.
Time frame: up to Day 168
Urine toxicology
Total number of monthly (28 days) 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 instrument.
Time frame: up to Day 168
Participant satisfaction with MOUD
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.
Time frame: up to Day 168
Total number of self-reported overdose events per total number of participant days at risk.
The Overdose Calendar Recall instrument collects overdose events.
Time frame: up to Day 168
Total number of self-reported injection drug use related events during each 28-day assessment period.
Assessment of Infectious or Other Complications of Injection Drug Use assess for skin abscesses, ulcers , cellulitis, osteoarticular septic arthritis, osteomyelitis, epidural infection , endovascular, new injection-related viral infections diagnosis of Hepatitis or HIV.
Time frame: Up to Day 168
Mean score Pain measured using Pain, Enjoyment of Life and General Activity (PEG) Scale (PEG-3)
Mean scores on the PEG-3 instrument over time. The PEG-3 instrument is collected every 28 days. The mean score is the average of the three 0-10 rated items. Total score range 0-10. Higher scores indicate worse pain.
Time frame: Up to Day 168
Total number of self-reported days with acute care utilization (ED or hospitalization) during each 28-day assessment period.
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.
Time frame: Up to Day 168
Total number of behavioral counseling service visits attended per participant during each 28-day assessment period.
Assessed by EMR extraction and the Health Services Utilization.
Time frame: Up to Day 168
Total number of planned prescriber visits attended during each 28-day assessment period.
Assessed by EMR extraction.
Time frame: Up to Day 168
Pharmacist practice fidelity
Assessed by MOUD Visit Checklist completion over time. The MOUD Visit Checklist collects clinical activities that might be performed by a pharmacist at each pharmacy, such as performing medication reconciliation; conducting safety assessments, adverse effects of methadone, recent overdose events, checking the patient's controlled medications prescription status using the PDMP before dispensing methadone; providing patient education/counseling; communicating with the clinician regarding any concern; and administering one methadone dose at the pharmacy and/or dispensing methadone according to the prescription.
Time frame: Up to Day 168