Opioid Use DisorderPhase 3NCT06306443
Buprenorphine for Individuals in Jail
A Phase 3 study testing extended-release buprenorphine (XR-B) in people with Opioid Use Disorder, run by Friends Research Institute, Inc. at 2 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Opioid Use Disorder
- What is being tested?
- extended-release buprenorphine (XR-B)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 Jun 2025to 30 Apr 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult male or female inmates at participating jail who are eligible for release within 120 days (sentenced and/or pretrial [note: individuals who might be sentenced to state/federal prison will be excluded]); Those individuals who are pre-trial and/or sentenced who are completing their sentence in the community (probation, parole, home detention, electronic monitoring, drug or other treatment court [or equivalent]) will be eligible to participate;
- 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 SL-B treatment as determined by medical evaluation;
- Willingness to enroll in XR-B or SL-B treatment in jail and continue in the community;
- Planning to live in Baltimore City or the Baltimore Region;
Who cannot join
- Liver function test levels greater than 5 times normal (if we are unable to obtain labs, a determination by the study physician will be made to allow inclusion);
- 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 buprenorphine;
- Suicidal ideation (within the past 6 months);
- Inability to pass a study enrollment quiz; and
- Currently receiving non-buprenorphine MOUD in jail (methadone, naltrexone).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Friends Research Institute
Baltimore, Maryland, 21201
Michael Gordon, 4108373977, mgordon@friendsresearch.org
- Recruiting
Baltimore Central Booking & Intake Center
Baltimore, Maryland, 21202
Michael Gordon, DPA, 4108373977 ext. 251, mgordon@friendsresearch.org
Thomas R Blue, PhD, 4108373977, tblue@friendsresearch.org
About this study
Official title: A Comparative Effectiveness Trial of Sublingual Versus Extended-release Buprenorphine With Individuals Leaving a Carceral Setting
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.
Read the detailed description
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
- Conditions
- Opioid Use Disorder
- Being tested
- extended-release buprenorphine (XR-B)
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
extended-release buprenorphine (XR-B)Drug
Also called sublingual buprenorphine (SL-B)
buprenorphine
| Study group | Role | What they receive |
|---|---|---|
| extended-release buprenorphine (XR-B) | Experimental | 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. Receives: Drug: extended-release buprenorphine (XR-B) |
| sublingual buprenorphine (SL-B) | Active comparator | 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. Receives: Drug: extended-release buprenorphine (XR-B) |
What is being measured
The primary outcome is the main question the study is designed to answer.
urine toxicology
positive urine drug screen for opioids
Measured: 12-months
days of opioid use
Number of days since last assessment
Measured: 12-months
time to opioid relapse
days from release from jail to first relapse event
Measured: 12-months
Secondary outcomes (9)
retention in buprenorphine treatment
days receiving buprenorphine
Measured: 6-months
urine toxicology for other illicit substance use
positive urine drug screen
Measured: 12-months
days of illicit substance use
number of days since last assessment
Measured: 12-months
overdose events
fatal and non-fatal overdose events
Measured: 12-months
PROMIS Patient-Reported Outcomes Measurement Information System - physical health
Global physical health score
Measured: 12-months
PROMIS Patient-Reported Outcomes Measurement Information System - mental health
Global mental health score
Measured: 12-months
HIV risk behaviors (Risk Assessment Battery, RAB) - sex risk score
sexual risk behavior; Scored 0-18 (higher risk)
Measured: 12-months
HIV risk behaviors (Risk Assessment Battery, RAB) needle use or sharing score
needle use or sharing; Scored 0-22 (higher risk)
Measured: 12-months
criminal activity
- crime days; ii. re-arrest; iii. technical violations; iv. re-incarceration
Measured: 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start20 Jun 2025
- Primary completion1 Jan 2029 (estimated)
- Study completion30 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Friends Research Institute, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06306443
- Sponsor's protocol ID
- 20235453
- Status last verified
- May 2026
- First submitted
- 28 Feb 2024
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Working on a plan.
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Effectiveness Trial of Sublingual Versus Extended-release Buprenorphine With Individuals Leaving a Carceral Setting
- ClinicalTrials.gov ID
- NCT06306443
- Acronym / sponsor ID
- 20235453
- Conditions
- Opioid Use Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Friends Research Institute, Inc.University, hospital or other
- Study start
- 20 Jun 2025 (actual)
- Primary completion
- 1 Jan 2029 (estimated)
- Study completion
- 30 Apr 2029 (estimated)
- First posted
- 12 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| extended-release buprenorphine (XR-B) | Experimental | 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. 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. |
| sublingual buprenorphine (SL-B) | Active comparator | 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult male or female inmates at participating jail who are eligible for release within 120 days (sentenced and/or pretrial [note: individuals who might be sentenced to state/federal prison will be excluded]); Those individuals who are pre-trial and/or sentenced who are completing their sentence in the community (probation, parole, home detention, electronic monitoring, drug or other treatment court [or equivalent]) will be eligible to participate;
- 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 SL-B treatment as determined by medical evaluation;
- Willingness to enroll in XR-B or SL-B treatment in jail and continue in the community;
- Planning to live in Baltimore City or the Baltimore Region;
Key exclusion criteria (8 listed)
- Liver function test levels greater than 5 times normal (if we are unable to obtain labs, a determination by the study physician will be made to allow inclusion);
- 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 buprenorphine;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| extended-release buprenorphine (XR-B)Also: sublingual buprenorphine (SL-B)buprenorphine | Drug | extended-release buprenorphine (XR-B), sublingual buprenorphine (SL-B) |
Primary outcome
urine toxicology
Time frame: 12-months
positive urine drug screen for opioids
days of opioid use
Time frame: 12-months
Number of days since last assessment
time to opioid relapse
Time frame: 12-months
days from release from jail to first relapse event
9 secondary outcomes
retention in buprenorphine treatment
Time frame: 6-months
urine toxicology for other illicit substance use
Time frame: 12-months
days of illicit substance use
Time frame: 12-months
overdose events
Time frame: 12-months
PROMIS Patient-Reported Outcomes Measurement Information System - physical health
Time frame: 12-months
PROMIS Patient-Reported Outcomes Measurement Information System - mental health
Time frame: 12-months
HIV risk behaviors (Risk Assessment Battery, RAB) - sex risk score
Time frame: 12-months
HIV risk behaviors (Risk Assessment Battery, RAB) needle use or sharing score
Time frame: 12-months
criminal activity
Time frame: 12-months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Individual participant dataSharing planned: Yes. Working on a plan.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing extended-release buprenorphine (XR-B) in people with Opioid Use Disorder, run by Friends Research Institute, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael Gordon, DPA (4108373977 ext. 251, mgordon@friendsresearch.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
urine toxicology (time frame: 12-months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.