Justice Community Overdose Innovation Network (JCOIN) 1.0: Brixadi Versus Extended-Release Naltrexone Hub, Client Data, Maryland, 2020-2024 (ICPSR 39913)

Time Period(s) View help for Time Period(s)

Date of Collection View help for Date of Collection

Data Collection Notes View help for Data Collection Notes

Study Purpose View help for Study Purpose

The primary aim was to determine the rate of pharmacotherapy adherence (number of monthly injections received) of extended-release buprenorphine (XR-B; BRIXAD(TM) formulation) compared to extended-release naltrexone (XR-NTX).

Study Design View help for Study Design

This study was a Type 1 hybrid effectiveness-implementation trial. County jails willing to provide extended-release naltrexone (XR-NTX) and extended-release buprenorphine (XR-B) participated in a randomized controlled trial (RCT) throughout the state of Maryland, in which 286 incarcerated men and women were 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 used 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.

Sample View help for Sample

Homogeneous convenience sampling was used to identify 286 adults interested in participating, excluding individuals who were actively going through withdrawal or the detoxification process. Interested individuals were then consented and screened.

Inclusion criteria were:

1. Adult inmates at participating jails who were eligible for release within 120 days;
2. History of opioid use disorder (OUD) (i.e., meeting DSM-5 criteria of moderate or severe OUD at the time of incarceration; individuals not meeting the OUD criterion were eligible if they were treated in an opioid agonist treatment program during the year before incarceration);
3. Suitability for extended-release buprenorphine (XR-B; BRIXAD(TM) formulation) and/or extended-release naltrexone (XR-NTX) as determined by medical evaluation;
4. Willingness to enroll in XR-B or XR-NTX treatment in jail; and
5. Planning to live in one of the seven participating or surrounding counties.

Exclusion criteria were:

1. Liver function test levels greater than 4 times normal;
2. Active medical illness that may have made participation hazardous;
3. Conditions or medications that may have predisposed to QTc prolongation (e.g., hypokalemia [low potassium levels in blood] and macrolide antibiotics [azithromycin, clarithromycin, and erythromycin]);
4. Untreated psychiatric disorder that may have made participation hazardous;
5. History of allergic reaction to naltrexone or buprenorphine;
6. Current chronic pain diagnosis for which opioids are prescribed;
7. Pregnancy;
8. Breast-feeding;
9. Suicidal ideation (within the past 6 months);
10. Body Mass Index (BMI) greater than 40;
11. Inability to pass a study enrollment quiz;
12. Currently enrolled in jail-based MOUD pharmacotherapy; and
13. Enrolled in a methadone treatment program in the past 30 days.

Time Method View help for Time Method

Universe View help for Universe

Adults with a history of opioid use disorder and incarcerated in one of seven, geographically diverse Maryland jails nearing release.

Unit(s) of Observation View help for Unit(s) of Observation

Data Type(s) View help for Data Type(s)

Mode of Data Collection View help for Mode of Data Collection

Presence of Common Scales View help for Presence of Common Scales

Global Appraisal of Individual Needs (GAIN) Q3 Risk Behavior measures

Global Appraisal of Individual Needs (GAIN) SS/Q3 Substance Disorder Screener

Global Appraisal of Individual Needs (GAIN), Non-Study Medical and Other Services (Justice Involvement)

Global Appraisal of Individual Needs (GAIN)-I Infectious Disease Questions

Measures for Phenotypes and eXposures (PhenX) Toolkit / Internalizing Disorder Screener

Non-Study Medical and Other Services, Q3 (Service Utilization)

Patient-Reported Outcomes Measurement Information System (PROMIS) 29 + 2 / Patient-Reported Outcomes Measurement Information System Preference (PROPr) (Quality of Life)

Original Release Date View help for Original Release Date

2026-08-18