Exemplar Hospital Initiation Trial to Enhance Treatment Engagement - Comparative Effectiveness Trial of Extended Release Buprenorphine Versus Treatment as Usual for Hospitalized Patients With Opioid Use Disorder
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Gavin Bart
- 入组人数
- 344
- 试验地点
- 6
- 主要终点
- The proportion of participants engaged in OUD care on the 34th day following hospital discharge.
研究概览
简要总结
This study is a multi-site open-label randomized comparative effectiveness trial of a 28-day formulation of extended-release buprenorphine (XR-BUP) versus treatment as usual (TAU) for hospitalized patients with a moderate or severe opioid use disorder (OUD) seen by an addiction consultation service (ACS) and agreeing to initiate a medication for OUD (MOUD). Participants will be randomly assigned to XR-BUP or TAU to be received within 72 hours of anticipated hospital discharge. Follow up will occur at approximately 34, 90, and 180 days following hospital discharge.
详细描述
The study will randomize approximately 314 hospitalized men and women ages 18 years and older with opioid use disorder (OUD) moderate or severe and who have not been taking prescribed medication for OUD (MOUD) for 14 days or more prior to hospitalization. Eligibility will be determined over one or more assessments during the index hospitalization. Once eligibility has been determined, participants will be randomized 1:1 to either a single injection of extended-release buprenorphine or TAU, which will include methadone, sublingual buprenorphine, or naltrexone. Connection to OUD care and ongoing MOUD following hospitalization will be per community standard. Participants will be assessed for engagement in OUD treatment by the presence of a legitimately prescribed MOUD on day 34 following hospital discharge. Further outcomes will be assessed at 90 and 180 days following hospital discharge.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hospitalized.
- •At least 18 years of age.
- •Meet Diagnostic and Statistical Manual (DSM-5) criteria for moderate or severe OUD.
- •Willing to initiate MOUD, including buprenorphine.
- •Able to speak English sufficiently to understand the study procedures and provide written informed consent to participate in the study.
排除标准
- •Anticipated length of stay less than 24-hours as determined by the ACS
- •Affected by a serious medical, psychiatric, or substance use disorder that, in the opinion of the study physician, would make it unsafe to participate in the study or may prevent collection of study data. This may include:
- •Disabling terminal diagnosis for which discharge from hospital is not anticipated.
- •Disabling terminal diagnosis for which hospice care is being sought.
- •Severe alcohol or benzodiazepine use disorder that is anticipated to require complex medical detoxification which cannot be completed prior to randomization.
- •Taking a long-acting opioid other than buprenorphine (e.g., methadone, extended-release oxycodone, extended-release morphine) in the three consecutive days prior to randomization.
- •Liver enzyme tests (Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT)) more than 5 times upper limit of normal or chronic decompensated liver disease.
- •Currently pregnant.
- •Known allergy to buprenorphine or components of Atrigel delivery system.
- •Receipt of MOUD in the 14 days prior to hospitalization as maintenance treatment; however, patients may have received MOUD for withdrawal management during or prior to hospitalization at the time of enrollment.
- •Are currently in jail, prison or other overnight facility as required by court of law and/or is considered a prisoner under local law or is under current terms of civil commitment or guardianship.
- •Previously randomized as a participant in the study - individuals may only be enrolled and randomized once.
研究组 & 干预措施
Interventional
Single subcutaneous injection of a 28-day formulation of extended-release buprenorphine within 72 hours of anticipated hospital discharge.
干预措施: Extended Release Buprenorphine (Drug)
Treatment as Usual
Community standard of care that includes initiation of either methadone, sublingual (SL) buprenorphine, or naltrexone prior to hospital discharge.
干预措施: Treatment as Usual (Drug)
结局指标
主要结局
The proportion of participants engaged in OUD care on the 34th day following hospital discharge.
时间窗: 34 days post discharge from hospital
Engagement in OUD is defined as coverage with a legitimately prescribed MOUD on that 34th day regardless of the source of prescribed MOUD coverage (e.g., formalized treatment program, primary care, jail, etc.).
次要结局
- Proportion of participants that experience Adverse Events (AE)(34 days)
- Proportion of participants with self-reported opioid use(Days 34, 90 and 180 post hospital discharge)
- Self-reported 30- and 90-day hospital readmission rates(Days 30 and 90 post hospital discharge)
- Self-reported 30- and 90-day Emergency Department (ED) visit rates(Days 30 and 90 post hospital discharge)
- Proportion of participants engaged with MOUD(Days 90 and 180 post hospital discharge)
- Proportion of participants with positive urine drug test(Days 34, 90 and 180 post hospital discharge)
研究者
Gavin Bart
Gavin Bart, MD PhD FACP DFASAM
Hennepin Healthcare Research Institute