A Phase 3 interventional study of extended-release buprenorphine (XR-B) in Opioid Use Disorder, sponsored by Friends Research Institute, Inc.. Recruiting at 2 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-04.
Sponsored by Friends Research Institute, Inc. · Phase 3, Interventional, and Treatment
This study is an open label randomized controlled trial of extended-release buprenorphine (BRIXADI, XR-B) vs. sublingual buprenorphine (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 a final long-term follow-up at 12-months.
This study is an open label randomized controlled trial of extended-release buprenorphine (BRIXADI, XR-B) vs. sublingual buprenorphine (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 a final long-term follow-up at 12-months.
Aim 1. Compare the effectiveness of XR-B vs. SL-B 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 versus 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.
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).
Costs. (a) cost to the correctional system; (b) costs associated with community intervention
1,411 studies on the registry are indexed under Opioid-Related Disorders; 290 are open to participants now.
This study's planned enrollment of 240 is above the median of 63 across 1,123 interventional studies indexed under Opioid-Related Disorders.
Browse Opioid-Related Disorders studies →Friends Research Institute, Inc. is the lead sponsor of 44 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive sublingual (sl; taken under the tongue) buprenorphine/naloxone doses of 2 mg for two days followed by 4mg for 2 days. The speed of induction will be based on their response to sl buprenorphine/naloxone. If they tolerate sl buprenorphine, on day 4 they will be administered an 8 mg dose of BRIXADI on day 5 (if they do not tolerate sl buprenorphine/naloxone we will extend sl dosing). During week two of dosing, they will receive 16 mg dose of BRIXADI will be given, based on the participant's response to the previous dose. During week three of dosing, they will receive a 24 mg dose of BRIXADI. During week four they will be administered a monthly dose of 64mg, 96mg, or 128mg. In all cases, the dose selected will be based on their response to the previous weeks' dose. We will endeavor to get you on the 96 mg or 128 mg monthly dose as there is a lack of opioid blockade data for the 64 mg monthly dose.
Drug: extended-release buprenorphine (XR-B)
Participants will receive sublingual (sl; taken under the tongue) buprenorphine/naloxone doses of 2 mg for two days followed by 4mg for 2 days. The speed of induction will be based on their response to sl buprenorphine/naloxone.
Drug: extended-release buprenorphine (XR-B)
buprenorphine
Also known as: sublingual buprenorphine (SL-B)
urine toxicology
positive urine drug screen for opioids
Time frame: 12-months
days of opioid use
Number of days since last assessment
Time frame: 12-months
time to opioid relapse
days from release from jail to first relapse event
Time frame: 12-months
retention in buprenorphine treatment
days receiving buprenorphine
Time frame: 6-months
urine toxicology for other illicit substance use
positive urine drug screen
Time frame: 12-months
days of illicit substance use
number of days since last assessment
Time frame: 12-months
overdose events
fatal and non-fatal overdose events
Time frame: 12-months
PROMIS Patient-Reported Outcomes Measurement Information System - physical health
Global physical health score
Time frame: 12-months
PROMIS Patient-Reported Outcomes Measurement Information System - mental health
Global mental health score
Time frame: 12-months
HIV risk behaviors (Risk Assessment Battery, RAB) - sex risk score
sexual risk behavior; Scored 0-18 (higher risk)
Time frame: 12-months
HIV risk behaviors (Risk Assessment Battery, RAB) needle use or sharing score
needle use or sharing; Scored 0-22 (higher risk)
Time frame: 12-months
criminal activity
i. crime days; ii. re-arrest; iii. technical violations; iv. re-incarceration
Time frame: 12-months
Plan to share: Yes — Working on a plan.
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Friends Research Institute, Inc.