# A comparative effectiveness trial of sublingual versus extended-release buprenorphine with individuals leaving a carceral setting

> **NIH NIH R01** · FRIENDS RESEARCH INSTITUTE, INC. · 2024 · $1,086,043

## Abstract

Abstract
Although previous research has demonstrated the effectiveness of initiating medications for opioid use disorder
(MOUDs) during incarceration, there has been very little adoption nationwide of this practice. Extended-release
buprenorphine (XR-B) is a promising intervention for the treatment of OUDs in carceral settings. Individuals
with OUDs re-entering the community are at an elevated risk for overdose and death from relapse to opioid
use among other opioid-related harms. This proposal builds on the current investigators experience conducting
clinical trials using both XR-B and sublingual-buprenorphine-naloxone (SL-B) with individuals in jail and prison.
This proposed study is a randomized controlled trial of XR-B vs. SL-B in a large metropolitan jail. An open-label
design will randomly assign 240 adults with moderate-to-severe OUDs who are soon-to-be-released from jail to
either XR-B (n = 120) or SL-B (n = 120) treatment in jail followed by 6-months of post-release buprenorphine
treatment, a 7-month safety visit, and final long-term follow-up at 12-months. The study has three aims: Aim 1.
Compare the effectiveness of XR-B vs. SL-B in terms of: Primary Outcome. (a) illicit opioid use (i. urine
toxicology; ii. self-reported days of opioid use using Timeline Followback; and iii. time to opioid relapse).
Secondary Outcomes. (b) retention in buprenorphine treatment (i. days receiving buprenorphine and ii. time to
treatment dropout); (c) other illicit substance use (i. urine toxicology; ii. self-reported days of illicit substance
use using Timeline Followback; (d) overdose events (non-fatal and fatal); (e) quality of life (i. physical health; ii.
mental health); (f) HIV risk behaviors (i. sexual risk behavior; ii. needle use or sharing); and (g) criminal activity
(i. crime days; ii. re-arrest; iii. technical violations; iv. re-incarceration). Aim 2. To calculate the cost to the state
and/or jail/city health system of implementing XR-B and SL-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. Aim 3. Explore barriers and facilitators to XR-B/SL-B implementation in jail: (1) dose induction; (2)
diversion and procedures for reducing diversion; (3) continuity of care after release or transfer to another
facility; (4) staffing (both custody and medical) needs for daily versus XR-B buprenorphine dosing; and (5)
patient preference for XR-B versus SL-B. The proposed study would be innovative because it would be the first
large scale RCT in the US assessing effectiveness and cost effectiveness of XR-B versus SL-B with individuals
in a jail who are re-entering community. Understanding how to expand acceptance of buprenorphine in jails,
has far-reaching implications for expanding treatment access in jail.

## Key facts

- **NIH application ID:** 10930138
- **Project number:** 5R01DA058674-02
- **Recipient organization:** FRIENDS RESEARCH INSTITUTE, INC.
- **Principal Investigator:** Thomas Blue
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $1,086,043
- **Award type:** 5
- **Project period:** 2023-09-30 → 2028-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10930138

## Citation

> US National Institutes of Health, RePORTER application 10930138, A comparative effectiveness trial of sublingual versus extended-release buprenorphine with individuals leaving a carceral setting (5R01DA058674-02). Retrieved via AI Analytics 2026-06-05 from https://api.ai-analytics.org/grant/nih/10930138. Licensed CC0.

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