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

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).

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

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.

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).

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

The Timeline Followback instrument collects self-reported drug and alcohol use.

The Timeline Followback instrument collects self-reported drug and alcohol use.

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.

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.

The Overdose Calendar Recall instrument collects overdose events.

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.

Mean scores on the PEG-3 screening instrument over time. Total score range is 0-10; the highest being the worse pain.

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.

Retention will be defined as the number of days of continuous office-based methadone treatment (time to event outcome) staring at day 168. Discontinuation of methadone for the extended study component will be defined as more than a self-reported 30-day gap in receipt of methadone or non-response on two consecutive 60-day assessments. The date of discontinuation will be the end of the last 30-day period with any self-reported office-based methadone treatment. Participants who remain in continuous treatment through the end of the study and will be censored on day of the last 60 day assessment. Only collected in extended study participants.

Percentage of days covered of self-reported pharmacy dispensed methadone treatment (i.e., number of self-reported days covered per total days observed). Only collected in extended study participants.

To assess overdose events, participants will self-report the number of overdose events in the past 28 days. Only collected in extended study participants.

Participants will self-report the most recent daily dose (in milligrams) of methadone prescribed and obtained from the pharmacy. Only collected in extended study participants.

Days of treatment will be the count of self-reported number of days the participant self reported taking prescribed methadone. Only collected in extended study participants.

The TEA collects self-report data across four domains: substance use, health, lifestyle, and community. This will be analyzed as a repeated measure of overall numerical score. Total score range 4-40. higher scores mean greater improvement. Only collected in extended study participants.

Participants will be asked to report the inpatient and outpatient services they used in the past 28 days. Only collected in extended study participants.

To assess health related quality of life, participants will self-report their general health, physical health, and mental health during the past 28 days. This will be analyzed as a repeated measure of overall numerical score. Only collected in extended study participants.

To assess crime and criminal justice, participants will self-report how many days in the past 60 days they have been incarcerated, if they have been in contact with the court, criminal justice system, or probation/parole officer and how many of those days in the past 60 they were incarcerated, in contact with the court, criminal justice system or probation/parole officer. Criminal justice involvement will be defined as the percentage of days of self-reported involvement (i.e., number of self-reported days per total days observed). Only collected in extended study participants.

End of study status for participants which includes; office-based methadone treatment at end of study, withdrew consent, deceased, unable to contact, no longer being prescribed methadone from the site. End of study status will be reported by study site Research Associates or Site Clinicians. Only collected in extended study participants.

To assess substance use, participants will self-report how many of the past 60 days that they used a substance. Monthly substance use obtained through survey assessment at each 60- day assessment. Total number of days of self-reported substance use during each 60 day assessment period (discrete or continuous outcome, repeated measure). Only collected in extended study participants.