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| ID | Type | Description | Link |
|---|---|---|---|
| CTN-0131 | Other Identifier | Clinical Trials Network | |
| 5UG1DA015831-21 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute on Drug Abuse (NIDA) | NIH |
| The Emmes Company, LLC | INDUSTRY |
| University of California, San Francisco |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Office-based methadone | Experimental | 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). |
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| Office-based buprenorphine (BUP) | Active Comparator | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methadone | Drug | Drug: Methadone Possible formulations: 10 and 50 mg tablets |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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). | up to Day 168 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | The MOUD Calendar Based Recall (Self-Report) form is used to collect self-reported prescribed medications for OUD. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Retention in office-based methadone treatment | 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. |
Inclusion Criteria
Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jessica Research Associate | Contact | 203-785-6821 | j.mckenzie@yale.edu | |
| Melissa Gordon | Contact | 203-937-3486 | 7415 | melissa.gordon@yale.edu |
| Name | Affiliation | Role |
|---|---|---|
| David Fiellin, MD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Highland Hospital Bridge Clinic at Alameda Health System | Recruiting | Oakland | California | 94602 | United States |
The National Institute on Drug Abuse (NIDA) Data Share web site is an electronic environment that allows data from completed clinical trials to be distributed to investigators and the public in order to promote new research, encourage further analyses, and disseminate information to the community. Secondary analyses produced from data sharing multiply the scientific contribution of the original research. NIH expects and supports the timely release and sharing of final research data from NIH-supported studies for use by other researchers to expedite the translation of research results into knowledge, products and procedures to improve human health.
Data sets will be available after (1) the primary paper has been accepted for publication, or (2) the data is locked for more than 18 months, whichever comes first.
Public
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| OTHER |
| Boston Medical Center (BMC) | UNKNOWN |
| Hennepin Healthcare Research Institute | OTHER |
| Alameda Health System | OTHER |
| Marshall Health | UNKNOWN |
| Kaiser Permanente | OTHER |
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.
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| Buprenorphine (BUP) |
| Drug |
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) |
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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. |
| up to Day 168 |
| Number of days prescribed any FDA-approved MOUD formulation during the 168 days post-randomization. | 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). | up to Day 168 |
| Number of days of self-reported non-prescribed opioid use per month. | The Opioid Use Calendar Based Recall instrument is used to collect self-reported non-prescribed opioid use. | up to Day 168 |
| Number of days of self-reported non-prescribed stimulant use per month. | The Timeline Followback instrument collects self-reported drug and alcohol use. | up to Day 168 |
| Number of days of self-reported non-prescribed benzodiazepine use per month. | The Timeline Followback instrument collects self-reported drug and alcohol use. | up to Day 168 |
| Urine toxicology | 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. | 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. | 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. | up to Day 168 |
| Total number of self-reported injection drug use related events per total number of participant days at risk. | 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. | Up to Day 168 |
| Pain measured using PEG-3: "Pain average," "interference with Enjoyment of life," and "interference with General activity." | Mean scores on the PEG-3 screening instrument over time. Total score range is 0-10; the highest being the worse pain. | 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. | 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. | Up to Day 168 |
| Starting at day 168 post enrollment up to 2years |
| Percentage of days covered of self-reported pharmacy dispensed methadone treatment | 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. | starting at day 168 post enrollment up to 2 years |
| Total number of self-reported overdose events | To assess overdose events, participants will self-report the number of overdose events in the past 28 days. Only collected in extended study participants. | Starting at day 168 post enrollment up to 2years |
| Methadone dose | 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. | Starting at day 168 post enrollment up to 2years |
| Days of treatment | 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. | Starting at day 168 post enrollment up to 2years |
| Treatment Effectiveness Assessment (TEA) | 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. | Starting at day 168 post enrollment up to 2years |
| Health service utilization | Participants will be asked to report the inpatient and outpatient services they used in the past 28 days. Only collected in extended study participants. | Starting at day 168 post enrollment up to 2years |
| Health related quality of life | 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. | Starting at day 168 post enrollment up to 2years |
| Crime and criminal justice involvement | 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. | Starting at day 168 post enrollment up to 2years |
| End of study status | 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. | Starting at day 168 post enrollment up to 2years |
| Substance use | 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. | Starting at day 168 post enrollment up to 2years |
| Outpatient Buprenorphine Induction Clinic, University of California, San Francisco | Recruiting | San Francisco | California | 94103 | United States |
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| Rapid Start Clinic, Kaiser Permanente Colorado | Recruiting | Denver | Colorado | 80205 | United States |
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| Officed Based Addiction Treatment Program, Boston Medical Center | Recruiting | Boston | Massachusetts | 02118 | United States |
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| Hennepin Healthcare Addiction Medicine | Recruiting | Minneapolis | Minnesota | 55415 | United States |
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| Marshall University Division of Addiction Sciences P.R.O.A.C.T | Recruiting | Huntington | West Virginia | 25703 | United States |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D008691 | Methadone |
| D002047 | Buprenorphine |
| ID | Term |
|---|---|
| D007659 | Ketones |
| D009930 | Organic Chemicals |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
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