Study Overview

A Comparative Effectiveness Trial of Extended-Release Naltrexone versus Extended-Release Buprenorphine with Individuals Leaving Jail

Principal Investigator (Primary Contact): Michael S. Gordon, D.P.A.
Co-Principal Investigator: Shannon Gwin Mitchell, Ph.D.
Co-Investigator: Thomas Blue, Ph.D.
Co-Investigator: Frank Vocci, Ph.D.
Co-Investigator: Sean Murphy, Ph.D.
Co-Investigator: Marc Fishman, M.D.
Project Manager: Kathy Couvillion

Funded By: National Institute on Drug Abuse (NIDA)
Grant #: UG1DA050077
Total Project Period: 7/19 – 4/24

This study is a randomized, open label, controlled trial of extended-release buprenorphine (XR-B; BRIXADI™ formulation) versus extended-release naltrexone (XR-NTX) in Maryland jails. A mulit-site, open-label, equivalence design will randomly assign 240 adults with a history of opioid use disorder (OUD) within gender and jail who are nearing release to one of two treatment arms: 1) XR-B in jail or 2) XR-NTX in jail, both followed by 6 monthly injections post-release at a community treatment program.

Aim 1. To determine the effectiveness of XR-B compared to XR-NTX in terms of: Primary Outcome. (a) pharmacotherapy adherence (number of monthly injections received). Secondary Outcomes. (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 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. To calculate the cost to the jail/county health system of implementing XR-NTX/XR-B, and determine the relative value, including the costs associated with the interventions in the community, from a county and state-policymaker and societal perspective.