Extended Release Naltrexone Versus Extended Release Buprenorphine With Individuals Leaving Jail

Opioid-use Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04408313
• Other study ID #: 1UG1DA050077
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: October 28, 2020
• Est. completion date: December 31, 2025

Study information

• Verified date: February 2024
• Source: Friends Research Institute, Inc.
• Contact: Michael S Gordon, DPA
• Phone: 410-837-3977
• Email: mgordon[@]friendsresearch.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: December 31, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Opioid-Related Disorders
• Opioid-use Disorder

Intervention

Drug:
• XR-B
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.
• XR-NTX
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.

Locations

Country	Name	City	State
United States	Friends Research Institute	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Friends Research Institute, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pharmacotherapy adherence	number of monthly injections received (0-6)	6-months post-release
Secondary	illicit opioid urine screening test results	number of illicit opioid positive urine drug screen results	1-7,12-months
Secondary	self-reported illicit opioid use	self reported days of illicit opioid use	Baseline, 1-7,12-months
Secondary	overdose events	number of fatal and non-fatal overdoses	Baseline, 1-7,12-months
Secondary	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
Secondary	Risk Assessment Battery (RAB)	HIV risk behaviors; total score/40 (range=0-1)	Baseline, 1-7,12-months
Secondary	Criminal activity	number of days committed crime (20 crimes)	Baseline, 1-7,12-months
Secondary	Re-arrest	time to rearrest (days to arrest)	12-months
Secondary	Re-incarceration	time to re-incarceration (days to re-incarceration)	12-months