Extended Release Naltrexone Versus Extended Release Buprenorphine With Individuals Leaving Jail

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Comparative Effectiveness Trial of Extended Release Naltrexone Versus Extended Release Buprenorphine With Individuals Leaving Jail

Conditions
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Opioid-use Disorder

Intervention / Treatment
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* Drug: XR-B
* Drug: XR-NTX


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: XR-B<br>Extended-release buprenorphine | Drug: XR-B<br>* Individuals will receive extended-release buprenorphine, administered as a subcutaneous injection, is available in seven different dosage strengths for weekly (8, 16, 24, and 32 mg) and monthly (64, 96, and 128 mg) administration by a health care professional.<br>* Other names: extended-release buprenorphine;|
| Active Comparator: XR-NTX<br>Extended-release naltrexone | Drug: XR-NTX<br>* Injectable naltrexone will be used, at a dose of 4cc (380mg of naltrexone), administered by intramuscular injection to the buttocks (alternating sides monthly). Individuals will receive monthly injections.<br>* Other names: extended-release naltrexone;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pharmacotherapy adherence | number of monthly injections received (0-6) | 6-months post-release | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| illicit opioid urine screening test results | number of illicit opioid positive urine drug screen results | 1-7,12-months | 
| self-reported illicit opioid use | self reported days of illicit opioid use | Baseline, 1-7,12-months | 
| overdose events | number of fatal and non-fatal overdoses | Baseline, 1-7,12-months | 
| Patient-Reported Outcomes Measurement Information System | physical, mental, and social health scored 0: Death scored < 1: A state worse than perfect health | Baseline, 1-7,12-months | 
| Risk Assessment Battery (RAB) | HIV risk behaviors; total score/40 (range=0-1) | Baseline, 1-7,12-months | 
| Criminal activity | number of days committed crime (20 crimes) | Baseline, 1-7,12-months | 
| Re-arrest | time to rearrest (days to arrest) | 12-months | 
| Re-incarceration | time to re-incarceration (days to re-incarceration) | 12-months |