Assessing Optimal Extended-Release Buprenorphine (XRB) Initiation Points in Jail
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 8
- 主要终点
- Percentage of participants released from jail with at least 7 days of buprenorphine in their system
研究概览
简要总结
This application describes a 3-year, randomized controlled trial. Eligible, consenting adults (N=200) with existing sublingual buprenorphine (SLB) prescriptions who enter Middlesex County House of Corrections (MCHOC) as pre-trial detainees will be randomized at admission on a 1:1 basis to be inducted onto extended-release buprenorphine (XRB) at the time of admission (experimental condition) or remain in SLB (E-TAU; all participants will also receive naloxone). The two approaches will be compared with regard to (1) the percentage of participants released from jail with at least 7 days of buprenorphine in their system, (2) percentage of participants continuing MOUD treatment in the community, and (3) infractions related to buprenorphine diversion.
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
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Incarcerated men able to provide written informed consent in English.*
- •Unsentenced.
- •Entering the facility with a prescription for SLB and receiving SLB for at least the previous 3 days.
- •Minimum anticipated jail stay is 4 days.
- •Willing to accept being randomized to the experimental condition (i.e., transitioning to XRB while incarcerated).
排除标准
- •Sentenced.
- •Allergy, hypersensitivity or medical contraindication to either medication.
- •Chronic pain requiring opioid pain management or other contraindicated medications.
研究组 & 干预措施
Transition to Extended-Release Buprenorphine (XRB)
Participants randomized to transition to treatment with XRB.
干预措施: Extended-Release Buprenorphine (XRB) (Drug)
Sublingual Buprenorphine (SLB) Maintenance
Participants randomized to remain on-treatment with SLB.
干预措施: Sublingual Buprenorphine (SLB) (Drug)
结局指标
主要结局
Percentage of participants released from jail with at least 7 days of buprenorphine in their system
时间窗: Up to Month 6
The percentage of participants leaving jail with at least 7 days of buprenorphine protection in their system. Measured using clinical and jail records.
次要结局
- Percentage of participants continuing MOUD treatment in the community(Up to Month 9)