Rapid Initiation of Buprenorphine/Naloxone to Optimize MAT Utilization in Philadelphia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Enrollment in Medication Assisted Treatment at 1-month Post-enrollment
研究概览
简要总结
The proposed research will evaluate the ability of a mobile, rapid induction procedure to engage individuals in ongoing medication assisted treatment. A total of 250 untreated individuals meeting criteria for opioid use disorder and at high risk of opioid overdose will be enrolled in the study. Recruitment will take place in two targeted neighborhoods of Philadelphia (Kensington and South Philadelphia) with a high prevalence of fatal and non-fatal opioid overdose. A total of 250 participants will be engaged in the research. Following informed consent and determination of eligibility, 125 individuals will be enrolled as they engage with the mobile, rapid induction team and 125 individuals will be enrolled as they seek treatment from the CRC Episcopal Hospital (serving Kensington area) or BAC/CRC Hall Mercer Community Mental Health (serving South Philadelphia). The intervention group will receive four weeks of treatment with buprenorphine /naloxone and support for treatment engagement provided by a case manager and a peer recovery specialist. All participants will be assessed at baseline and then 1- and 6-month following enrollment. The primary endpoint for the study is continued enrollment in medication-assisted treatment at 6-month post-enrollment.
The proposed research will evaluate the ability of a mobile, rapid induction procedure to engage individuals in ongoing medication assisted treatment.
The specific aims are:
- Aim 1: To evaluate the impact of the mobile, transitional MAT intervention on its ability to engage participants in targeted, existing MAT treatment slots at 1- and 6-month post-enrollment.
- Aim 2: To evaluate the impact of the mobile intervention on subsequent drug use and overdoses at 6-month post-enrollment.
- Aim 3: To assess the acceptability and costs of the intervention. The program and patient costs of delivering and participating in the intervention will be documented.
详细描述
- Study Objectives Aim 1: To evaluate the impact of the mobile, transitional MAT intervention on its ability to engage participants in targeted, existing MAT treatment slots at 1- and 6-month post-enrollment.
Aim 2: To evaluate the impact of the mobile intervention on subsequent drug use and overdoses at 6-month post-enrollment.
Aim 3: To assess the acceptability and costs of the intervention. The program and patient costs of delivering and participating in the intervention will be documented.
Study participants who will receive buprenorphine/naloxone will be provided with information, counseling, and support for selection of ongoing treatment options including methadone maintenance (MMT), extended-release naltrexone (XR-NTX), or continued treatment with buprenorphine/naloxone. 2. Study design Duration of Study Participation The duration of study participation including screening/baseline assessments to follow-up will be 6 months.
Total Number of Subjects A total of 250 participants will be engaged in the research at the time they seek treatment: 125 individuals will be enrolled as they engage with the mobile, rapid induction team and 125 individuals will be enrolled as they seek treatment from the BAC/CRC (treatment as usual).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Must be 18 years of age or older
- •Opioid overdose in the prior 12 months
- •Meet criteria for opioid use disorder
- •Resident of Philadelphia
- •Willingness and ability to participate in study procedures
排除标准
- •Inability to comprehend or complete study procedures
- •Plans to relocate during study time frame
- •Currently in medication assisted treatment (MAT) for substance use disorder
- •Evidence of serious liver disease (LFTs > 3 x the upper limit of normal)
- •Pregnancy or lactation
- •Moderate to severe alcohol or benzodiazepine use disorder
研究组 & 干预措施
Rapid initiation
Rapid initiation of buprenorphine/naloxone, counseling, peer support and case management
干预措施: buprenorphine/naloxone (Drug)
Treatment as usual
Seeking treatment from the BAC/CRC (treatment as usual)
干预措施: buprenorphine/naloxone (Drug)
结局指标
主要结局
Enrollment in Medication Assisted Treatment at 1-month Post-enrollment
时间窗: 1-month post-enrollment
Number of participants receiving treatment with medication for opioid use disorder at 1-month post-enrollment
次要结局
- Enrollment in Medication Assisted Treatment at 6-month Post-enrollment(6-month follow-up)
- Change in Opioid Use From Baseline to 6-month Follow-up(6 months)
- Overdose During the 6-month Follow-up(6 months)
- Economic Value of the Mobile Intervention Relative to Treatment as Usual(Cost of 1-month intervention --- could not address this outcome)