A Comparative Effectiveness Trial of Extended Release Naltrexone Versus Extended Release Buprenorphine With Individuals Leaving Jail
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- pharmacotherapy adherence
研究概览
简要总结
The proposed study is a Type 1 hybrid effectiveness-implementation trial. Individuals with opioid use disorder in county jails throughout the state of Maryland will be randomly assigned within gender within jail to one of two groups: Arm 1. XR-B (n=120). XR-B in jail followed by 6 monthly injections post-release at a community treatment program. Arm 2. XR-NTX (n=120). One injection of XR-NTX in jail, followed by 6 monthly injections post-release at a community treatment program.
详细描述
This study is a Type 1 hybrid effectiveness-implementation trial. County jails willing to provide extended-release naltrexone (XR-NTX) and extended-release buprenorphine (XR-B) will participate in a randomized controlled trial throughout the state of Maryland, in which 240 incarcerated men and women will be randomly assigned within gender within jail to one of two arms: Arm 1. XR-B (n=120). XR-B in jail followed by 6 monthly injections post-release at a treatment program. Arm 2. XR-NTX (n=120). XR-NTX in jail, followed by 6 monthly injections post-release at a treatment program. In addition to the RCT the investigators will use a learning collaborative to examine the acceptability and feasibility of medications for opioid use disorder (MOUDs). Aim 1. To determine the effectiveness of XR-B compared to XR-NTX in terms of: Primary. (a) pharmacotherapy adherence (number of monthly injections received). Secondary. (b) illicit opioid urine test results; (c) self-reported illicit opioid use; (d) overdose events (non-fatal and fatal); (e) quality of life (i. physical health; ii. mental health); (f) HIV risk behaviors (i. sexual behavior; ii. needle use or sharing); and (g) criminal activity (i. crime days; ii. re-arrest; iii. re-incarceration). Aim 2. To use a learning collaborative involving all 7 RCT county jurisdictions as well as 3 additional counties that selected not to participate in the randomized trial to understand factors related to: (a) acceptability of providing long-acting agonists and antagonists in jail settings; and (b) feasibility of providing medication continuity of care from jail to community treatment providers. Aim 3. Calculate the cost to the correctional health system of implementing an XR-B or XR-NTX program, and determine the relative value of each strategy, including the costs associated with the subsequent interventions in the community, from a state-policymaker and societal perspective.
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
- •Adult male or female inmates at participating jails who are eligible for release within 120 days
- •History of opioid use disorder (meeting DSM-5 criteria of moderate or severe opioid use disorder at the time of incarceration; individuals not meeting the opioid-disorder criterion will be eligible if they were treated in an opioid agonist treatment program during the year before incarceration)
- •Suitability for XR-B and/or XR-NTX treatment as determined by medical evaluation
- •Willingness to enroll in XR-B or XR-NTX treatment in jail
- •Planning to live in one of the 7 participating counties and/or surrounding counties
排除标准
- •Liver function test levels greater than 4 times normal;
- •Active medical illness that may make participation hazardous (e.g., unstable diabetes, heart disease; moderate to severe renal impairment; adequately treated medical conditions are acceptable);
- •Conditions or medications that may predispose to QTc prolongation (personal or family history of long QT syndrome, hypokalemia, medications that prolong QTc interval, e.g., macrolide antibiotics, azole antifungal compounds, anti-arrythmics, antipsychotics and antidepressant)
- •Untreated psychiatric disorder that may make participation hazardous (e.g., untreated psychosis, bipolar disorder with mania; adequately treated psychiatric disorders and appropriate psychotropic medications will be allowed);
- •History of allergic reaction to naltrexone and/or buprenorphine;
- •Current chronic pain diagnosis for which opioids are prescribed;
- •Pregnancy (for women);
- •Breast-feeding (for women);
- •Suicidal ideation (within the past 6 months);
- •Body Mass Index (BMI) > 40;
- •Inability to pass a study enrollment quiz;
- •Currently enrolled in jail-based MOUD pharmacotherapy (methadone, buprenorphine, naltrexone)
- •Enrolled in a methadone treatment program in the past 30 days.
研究组 & 干预措施
XR-B
Extended-release buprenorphine
干预措施: XR-B (Drug)
XR-NTX
Extended-release naltrexone
干预措施: XR-NTX (Drug)
结局指标
主要结局
pharmacotherapy adherence
时间窗: 6-months post-release
number of monthly injections received (0-6)
次要结局
- illicit opioid urine screening test results(1-7,12-months)
- self-reported illicit opioid use(Baseline, 1-7,12-months)
- overdose events(Baseline, 1-7,12-months)
- Patient-Reported Outcomes Measurement Information System(Baseline, 1-7,12-months)
- Risk Assessment Battery (RAB)(Baseline, 1-7,12-months)
- Criminal activity(Baseline, 1-7,12-months)
- Re-arrest(12-months)
- Re-incarceration(12-months)