Office-based Methadone Versus Buprenorphine to Address Retention in Medication for Opioid Use Disorder Treatment - A Pragmatic Hybrid Effectiveness/Implementation Trial
概览
- 阶段
- 4 期
- 干预措施
- Methadone
- 疾病 / 适应症
- Opioid Use Disorder
- 发起方
- Yale University
- 入组人数
- 600
- 试验地点
- 12
- 主要终点
- 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.
- 状态
- 招募中
- 最后更新
- 16天前
概览
简要总结
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.
详细描述
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 sub-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.
研究者
入排标准
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Office-based 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).
干预措施: Methadone
Office-based 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).
干预措施: Buprenorphine (BUP)
结局指标
主要结局
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.
时间窗: 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) and the electronic medical record (EMR).
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.
时间窗: 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) and the electronic medical record (EMR).
次要结局
- Urine toxicology(up to Day 168)
- Participant satisfaction with MOUD(up to Day 168)
- 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)
- 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)
- Number of days prescribed any FDA-approved MOUD formulation during the 168 days post-randomization.(up to Day 168)
- Number of days of self-reported non-prescribed benzodiazepine use per month.(up to Day 168)
- Total number of self-reported overdose events per total number of participant days at risk.(up to Day 168)
- Total number of self-reported injection drug use related events per total number of participant days at risk.(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.(Up to Day 168)
- 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)
- 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)
- Number of days prescribed any FDA-approved MOUD formulation during the 168 days post-randomization.(up to Day 168)
- Number of days of self-reported non-prescribed opioid use per month.(up to Day 168)
- Number of days of self-reported non-prescribed stimulant use per month.(up to Day 168)
- Number of days of self-reported non-prescribed benzodiazepine use per month.(up to Day 168)
- Urine toxicology(up to Day 168)
- Participant satisfaction with MOUD(up to Day 168)
- Total number of self-reported overdose events per total number of participant days at risk.(up to Day 168)
- Total number of self-reported injection drug use related events per total number of participant days at risk.(Up to Day 168)
- Pain measured using PEG-3: "Pain average," "interference with Enjoyment of life," and "interference with General activity."(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.(Up to Day 168)