Extended Release Naltrexone Versus Extended Release Buprenorphine With Individuals Leaving Jail
- Registration Number
- NCT04408313
- Lead Sponsor
- Friends Research Institute, Inc.
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 240
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description XR-B XR-B Extended-release buprenorphine XR-NTX XR-NTX Extended-release naltrexone
- Primary Outcome Measures
Name Time Method pharmacotherapy adherence 6-months post-release number of monthly injections received (0-6)
- Secondary Outcome Measures
Name Time Method illicit opioid urine screening test results 1-7,12-months number of illicit opioid positive urine drug screen results
self-reported illicit opioid use Baseline, 1-7,12-months self reported days of illicit opioid use
overdose events Baseline, 1-7,12-months number of fatal and non-fatal overdoses
Patient-Reported Outcomes Measurement Information System Baseline, 1-7,12-months physical, mental, and social health
* scored 0: Death
* scored \< 1: A state worse than perfect healthRisk Assessment Battery (RAB) Baseline, 1-7,12-months HIV risk behaviors; total score/40 (range=0-1)
Criminal activity Baseline, 1-7,12-months number of days committed crime (20 crimes)
Re-arrest 12-months time to rearrest (days to arrest)
Re-incarceration 12-months time to re-incarceration (days to re-incarceration)
Trial Locations
- Locations (1)
Friends Research Institute
🇺🇸Baltimore, Maryland, United States