Injectable Buprenorphine During Transition Out of Prison: A Partially Randomized Preference Pilot Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- Lifespan
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Implementation Outcomes: Feasibility
研究概览
简要总结
The goal of this pilot trial is to compare two branded extended-release buprenorphine (XR-B) formulations (Sublocade vs. Brixadi) to explore how they improve treatment retention after release from prison among incarcerated individuals with opioid use disorder (OUD) who are transitioning back into the community.
The main question it aims to answer are:
How do Sublocade and Brixadi compare in terms of feasibility, acceptability, and effectiveness? Does giving people a choice of medication affect how well they stay in treatment?
Using a partially randomized preference trial approach, there will be a comparison between participants who choose their XR-B formulation to those who are randomly assigned to see if patient preference influences treatment outcomes. The trial is a hybrid implementation-effectiveness trial.
Participants will:
- Choose which medication they prefer or be randomly assigned if they don't have a preference.
- Receive monthly injections of either Sublocade or Brixadi before and after release from prison.
- Complete surveys and clinical assessments on treatment experience and acceptability.
- Be monitored for treatment retention, opioid use, and adverse events for six months post-release.
Researchers will compare the two treatments to see which one works better for people leaving prison and if allowing people to choose their treatment improves results.
详细描述
This study is a pilot hybrid effectiveness-implementation trial using a partially randomized preference trial (PRPT) design to evaluate two formulations of extended-release buprenorphine (XR-B)-Sublocade and Brixadi-for the treatment of opioid use disorder (OUD) in individuals transitioning from prison to the community. The study is being conducted in collaboration with the Rhode Island Department of Corrections (RIDOC) to assess treatment retention, feasibility, and acceptability and other implementation outcomes in a carceral setting.
STUDY OBJECTIVES As a hybrid trial, the study will assess effectiveness and implementation outcomes. The primary objective of this study is to compare effectiveness (post-release treatment retention) among participants who receive Sublocade or Brixadi before and after release from prison. The study also aims to evaluate the impact of patient preference on treatment outcomes, including differences in retention between those who choose their treatment and those who are randomized. The study will also assess implementation outcomes including feasibility, acceptability, and fidelity.
STUDY DESIGN This is a pilot hybrid effectiveness-implementation trial that incorporates a partially randomized preference trial (PRPT) design.
Participants with a clear preference for either Sublocade or Brixadi will receive their preferred treatment. Participants with no strong preference will be randomized 1:1 using a stratified block randomization approach, stratified by gender, with blocks of four. Randomization assignments will be concealed using opaque sealed envelopes. The study is open-label, meaning both participants and study staff will be aware of treatment assignments. Given the preference-based design, blinding is not feasible.
STUDY SETTING The study will recruit participants from RIDOC, which has a long-standing MOUD program. Eligible participants are incarcerated individuals with upcoming release dates that express interest in XR-B and have no contraindications to treatment.
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
- •be at least 18 years of age and incarcerated in the RIDOC facility,
- •be currently diagnosed with OUD and enrolled in the RIDOC MOUD program,
- •have an expected release date within 120 days of study enrollment,
- •have an interest in XR-B and
- •be English speaking
排除标准
- •individuals who are pregnant or planning conception,
- •diagnosed with a severe or acute medical or psychiatric disability preventing safe study participation or making follow-up unlikely,
- •have a release date within 21 days of initiation, or
- •have previously had an allergy to buprenorphine. Post-enrollment exclusion will include individuals if there is a change in release date beyond the 120 days and therefore no longer meet original inclusion criteria. These individuals would return to usual MOUD care.
研究组 & 干预措施
Brixadi
Participants receive Brixadi-branded injectable buprenorphine.
干预措施: Brixadi (Injectable Buprenorphine) (Drug)
Sublocade
Participants receive Sublocade-branded injectable buprenorphine.
干预措施: Sublocade (Drug)
结局指标
主要结局
Implementation Outcomes: Feasibility
时间窗: Baseline, Immediately after the intervention
Feasibility will be measured by the validated Feasibility of Intervention Measure (FIM) and enrollment rates. The Feasibility of Intervention Measure (FIM) evaluates the degree to which an intervention can be successfully used or implemented within a given setting. Scores are calculated using a 5-point Likert scale, where 1 = Completely Disagree and 5 = Completely Agree. The minimum possible score is 1, and the maximum possible score is 5. Higher scores indicate greater feasibility of implementing the intervention.
Preliminary Effectiveness
时间窗: 3 months post-release
Preliminary Effectiveness will be measured through rates of community treatment continuation post-release. Outpatient treatment engagement over the first three months post-release will be assessed using study records of CPC Recovery Clinic follow-up appointments. For patients that do not follow at the CPC Recovery Clinic, statewide administrative data from the Rhode Island Prescription Drug Monitoring Program (PDMP) database covering community pharmacy fills of buprenorphine products will be used to supplement treatment retention outcomes. PDMP data will also be used to track community treatment continuation for all participants from three to six months post-release. Participants will be logged as continuing buprenorphine treatment at each month if: (1) CPC Recovery Clinic records show that they were present at their scheduled follow-up visit, or (2) the PDMP indicates that they continued treatment elsewhere and have not had a gap of more than 30 days in dispensed medication.
Implementation Outcomes: Acceptability
时间窗: Baseline, Immediately after the intervention
Acceptability will be measured through initial patient preference, in-facility treatment retention, and the validated Acceptability of Intervention Measure (AIM). The Acceptability of Intervention Measure (AIM) assesses the extent to which an intervention is perceived as satisfactory or agreeable by stakeholders. Scores are calculated using a 5-point Likert scale, where 1 = Completely Disagree and 5 = Completely Agree. The minimum possible score is 1, and the maximum possible score is 5. Higher scores indicate greater acceptability of the intervention.
Implementation Outcomes: Appropriateness
时间窗: Baseline, Immediately after the intervention
Appropriateness will be measured by the validated Intervention Appropriateness Measure (IAM). The Appropriateness of Intervention Measure (IAM) measures how well an intervention fits with the setting, needs, or problem it is intended to address. Scores are calculated using a 5-point Likert scale, where 1 = Completely Disagree and 5 = Completely Agree. The minimum possible score is 1, and the maximum possible score is 5. Higher scores indicate greater perceived appropriateness of the intervention.
Implementation Outcomes: Fidelity
时间窗: Baseline, Immediately after the intervention
Fidelity will be measured by the proportion of doses administered within the 26-35 day range of appropriate dosing cadence.
次要结局
- Client Outcomes: Function - Healthcare Utilization(During the intervention)
- Client Outcomes: Function - Recidivism(During the intervention, 3 months after the intervention)
- Client Outcomes: Function - Return to Use(During the intervention)
- Client Outcomes: Satisfaction(During the intervention)
- Client Outcomes: Treatment Satisfaction(During the intervention)
研究者
Justin Berk
Associate Professor
Rhode Island Hospital