# A comparative effectiveness trial of extended release naltrexone versus extended-release buprenorphine with individuals leaving jail

> **NIH NIH UG1** · FRIENDS RESEARCH INSTITUTE, INC. · 2022 · $2,169,367

## Abstract

Abstract
The proposed study is a Type 1 hybrid effectiveness-implementation trial. Early adopters from
the Maryland extended-release naltrexone (XR-NTX) initiative and additional counties who are
willing to provide CAM2038, a new extended-release-buprenorphine (XR-B) formulation will
participate in a randomized controlled trial conducted in 7 counties (10 jails) throughout the state
of Maryland, in which 240 incarcerated men and women 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. 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.
The proposed study is innovative because it would be the first randomized clinical trial in the US
assessing effectiveness of receiving XR-B vs. XR-NTX in county jails. The public health impact
of the study will be highly significant and far-reaching because most individuals with OUD do not
receive treatment while incarcerated, thereby substantially raising their likelihood of relapse to
drug use, overdose death, HIV/AIDS infection, and re-incarceration. Finally, understanding how
to expand acceptance of medications for opioid use disorder in jails, particularly long-acting
medications, has far-reaching implications for treatment expansion in this population.

## Key facts

- **NIH application ID:** 10388285
- **Project number:** 5UG1DA050077-04
- **Recipient organization:** FRIENDS RESEARCH INSTITUTE, INC.
- **Principal Investigator:** Michael Scott Gordon
- **Activity code:** UG1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $2,169,367
- **Award type:** 5
- **Project period:** 2019-07-15 → 2024-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10388285

## Citation

> US National Institutes of Health, RePORTER application 10388285, A comparative effectiveness trial of extended release naltrexone versus extended-release buprenorphine with individuals leaving jail (5UG1DA050077-04). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10388285. Licensed CC0.

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