Opioid UsePhase 3NCT03616236
Buprenorphine for Probationers and Parolees: Bridging the Gap Into Treatment
A Phase 3 study testing Buprenorphine/Naloxone and Treatment as usual in people with Opioid Use, run by Friends Research Institute, Inc. at 1 site in United States.
Trial summary
This five-year study will evaluate the effectiveness of the administration of buprenorphine bridge treatment (BBT) to probationers and parolees compared to treatment as usual (TAU), which consists of referral to a community buprenorphine treatment program. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Opioid Use
- What is being tested?
- Buprenorphine/Naloxone and Treatment as usual
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2022to 30 Dec 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject must provide written informed consent prior to the conduct of any study-related procedures
- Male or female, 18-65 years of age, inclusive
- Be on parole or probation for at least the next 4 months
- Have a Baltimore City address, and (5) Primary diagnosis of (DSM-5) moderate-severe opioid use disorder (at least 4 symptoms) including current use and current physiologic dependence [Note: parolees not currently physically dependent will be allowed in the study].
Who cannot join
- Current medical condition that may prevent the participant from safely participating in the study as determined by medical evaluation
- Current psychosis or suicidal ideation
- Cognitive disorders that prevent the participant from passing a study enrollment quiz
- Any pending legal action that would interrupt study participation (eg, pending incarceration, probation/parole revocation, unadjudicated charges)
- Exposure to any investigational drug within 8 weeks of screening
- Current use benzodiazepines (such as Valium, Xanax and other sedatives), either prescribed or illicitly obtained
- Currently enrolled in a methadone maintenance treatment program or taking long-acting naltrexone.
Trial locations and contacts
1 site in 1 country.
United States1 site
Division of Parole & Probation
Baltimore, Maryland, 21202
About this study
This five-year study will evaluate the effectiveness of the administration of buprenorphine bridge treatment (BBT) to probationers and parolees compared to treatment as usual (TAU), which consists of referral to a community buprenorphine treatment program.
Read the detailed description
This five-year study will evaluate the effectiveness of the administration of buprenorphine bridge treatment (BBT) to probationers and parolees compared to treatment as usual (TAU), which consists of referral to a community buprenorphine treatment program. Project implementation will occur at Guilford Avenue, the primary intake unit for Baltimore City Community Supervision (Probation and Parole). The proposed study is a parallel two-group randomized controlled trial in which 160 men and 160 women with OUD on community supervision in Baltimore will be randomly assigned within community supervision status (probation or parole) and gender to one of two treatment conditions: (1) Buprenorphine Bridge Treatment (BBT): Participants will begin buprenorphine pharmacotherapy using the MedicaSafe buprenorphine dispensing device immediately after an on-site intake at a community supervision office and continue such treatment until they are transitioned to community buprenorphine treatment; or (2) Treatment as Usual (TAU): Participants will receive a referral to buprenorphine treatment in the community. Both conditions will receive information on overdose prevention. Participants will be assessed at baseline, and 1, 2, 3, 6, and 12 months post-intake using a comprehensive assessment battery. The Primary Aim: To compare the relative effectiveness of BBT to TAU in terms of: (a) illicit opioid drug test (oral saliva) results. The Secondary Aim: To examine the extent to which BBT is superior to TAU in terms of: (b) number of days receiving opioid treatment; (c) number of days using illicit opioids; (d) quality of life (i. physical health; ii. mental health); (e) HIV risk behaviors (i. sexual behavior; ii. needle use or sharing); (f) criminal activity; (g) re-arrest; and (h) re-incarceration. The proposed study is significant because the large number of probationers/parolees with OUD have limited access to an efficacious treatment, buprenorphine pharmacotherapy. The proposed study is innovative because it would be the first trial in the US assessing the effectiveness of interim buprenorphine initiated at a community supervision office compared to referral to a community treatment program. The public health impact would be widespread, as this model of care could be scaled-up throughout many areas of the US with criminal justice populations with high rates of OUD.
- Conditions
- Opioid Use
- Being tested
- Buprenorphine/Naloxone, Treatment as usual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buprenorphine/NaloxoneDrug
Also called BBT
Participants will begin buprenorphine pharmacotherapy using the MedicaSafe buprenorphine dispensing device immediately after an on-site intake at a community supervision office and continue such treatment until they are transitioned to community buprenorphine treatment
Treatment as usualOther
Also called TAU
Participants will receive a referral to buprenorphine treatment in the community
| Study group | Role | What they receive |
|---|---|---|
| TAU | Active comparator | Participants will receive a referral to buprenorphine treatment in the community. Receives: Other: Treatment as usual |
| BBT | Experimental | Participants will begin buprenorphine pharmacotherapy using the MedicaSafe buprenorphine dispensing device immediately after an on-site intake at a community supervision office and continue such treatment until they are transitioned to community buprenorphine treatment Receives: Drug: Buprenorphine/Naloxone |
What is being measured
The primary outcome is the main question the study is designed to answer.
opioid use
illicit opioid drug test (oral saliva) results
Measured: 12 months
Secondary outcomes (10)
treatment adherence
entered community based treatment
Measured: 12 months
treatment adherence
number of days receiving opioid treatment
Measured: 12 months
opioid use days
number of days using illicit opioids
Measured: 12 months
health-related quality of life
physical health using the SF-12 Health Survey
Measured: 12 months
health-related quality of life
mental health using the SF-12 Health Survey
Measured: 12 months
HIV risk behaviors
sexual behavior using the Risk Assessment Battery (RAB)
Measured: 12 months
HIV risk behaviors
needle use or sharing using the Risk Assessment Battery (RB)
Measured: 12 months
criminal activity
criminal activity days
Measured: 12 months
re-arrest
time to re-arrest
Measured: 12 months
re-incarceration
time to 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 posted6 Aug 2018
- Study start1 Jul 2022
- Primary completion31 Aug 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Why it stopped: Unable to recruit from study sites.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid UseStudies 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
- 320 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
- NCT03616236
- Sponsor's protocol ID
- FRI
- Status last verified
- Jan 2026
- First submitted
- 20 Jul 2018
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: FRI is committed to the open and timely dissemination of research outcomes. Investigators in the proposed activity recognize that promising new methods and strategies may arise during the course of the research. Fri will abide by the principles for sharing research resources as described by NIH in "Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources. Working with the research community, as well as the federal funding agency, FRI will serve the scientific community at large by sharing ideas and software to ensure that new knowledge benefits society. Our goals are to disseminate new ideas so the public can benefit from discoveries, and to generate new ideas for research and education. Any data shared will be de-identified and follow the regulations set forth in applicable Human Subjects Protection Guidelines.
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Buprenorphine for Probationers and Parolees: Bridging the Gap Into Treatment
- ClinicalTrials.gov ID
- NCT03616236
- Acronym / sponsor ID
- FRI
- Conditions
- Opioid Use
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Unable to recruit from study sites.
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Friends Research Institute, Inc.University, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 6 Aug 2018 (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 five-year study will evaluate the effectiveness of the administration of buprenorphine bridge treatment (BBT) to probationers and parolees compared to treatment as usual (TAU), which consists of referral to a community buprenorphine treatment program.
Detailed description
This five-year study will evaluate the effectiveness of the administration of buprenorphine bridge treatment (BBT) to probationers and parolees compared to treatment as usual (TAU), which consists of referral to a community buprenorphine treatment program. Project implementation will occur at Guilford Avenue, the primary intake unit for Baltimore City Community Supervision (Probation and Parole). The proposed study is a parallel two-group randomized controlled trial in which 160 men and 160 women with OUD on community supervision in Baltimore will be randomly assigned within community supervision status (probation or parole) and gender to one of two treatment conditions: (1) Buprenorphine Bridge Treatment (BBT): Participants will begin buprenorphine pharmacotherapy using the MedicaSafe buprenorphine dispensing device immediately after an on-site intake at a community supervision office and continue such treatment until they are transitioned to community buprenorphine treatment; or (2) Treatment as Usual (TAU): Participants will receive a referral to buprenorphine treatment in the community. Both conditions will receive information on overdose prevention. Participants will be assessed at baseline, and 1, 2, 3, 6, and 12 months post-intake using a comprehensive assessment battery. The Primary Aim: To compare the relative effectiveness of BBT to TAU in terms of: (a) illicit opioid drug test (oral saliva) results. The Secondary Aim: To examine the extent to which BBT is superior to TAU in terms of: (b) number of days receiving opioid treatment; (c) number of days using illicit opioids; (d) quality of life (i. physical health; ii. mental health); (e) HIV risk behaviors (i. sexual behavior; ii. needle use or sharing); (f) criminal activity; (g) re-arrest; and (h) re-incarceration. The proposed study is significant because the large number of probationers/parolees with OUD have limited access to an efficacious treatment, buprenorphine pharmacotherapy. The proposed study is innovative because it would be the first trial in the US assessing the effectiveness of interim buprenorphine initiated at a community supervision office compared to referral to a community treatment program. The public health impact would be widespread, as this model of care could be scaled-up throughout many areas of the US with criminal justice populations with high rates of OUD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAU | Active comparator | Other: Treatment as usualParticipants will receive a referral to buprenorphine treatment in the community. |
| BBT | Experimental | Drug: Buprenorphine/NaloxoneParticipants will begin buprenorphine pharmacotherapy using the MedicaSafe buprenorphine dispensing device immediately after an on-site intake at a community supervision office and continue such treatment until they are transitioned to community buprenorphine treatment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject must provide written informed consent prior to the conduct of any study-related procedures
- Male or female, 18-65 years of age, inclusive
- Be on parole or probation for at least the next 4 months
- Have a Baltimore City address, and (5) Primary diagnosis of (DSM-5) moderate-severe opioid use disorder (at least 4 symptoms) including current use and current physiologic dependence [Note: parolees not currently physically dependent will be allowed in the study].
Key exclusion criteria (7 listed)
- Current medical condition that may prevent the participant from safely participating in the study as determined by medical evaluation
- Current psychosis or suicidal ideation
- Cognitive disorders that prevent the participant from passing a study enrollment quiz
- Any pending legal action that would interrupt study participation (eg, pending incarceration, probation/parole revocation, unadjudicated charges)
- Exposure to any investigational drug within 8 weeks of screening
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 |
|---|---|---|
| Buprenorphine/NaloxoneAlso: BBTParticipants will begin buprenorphine pharmacotherapy using the MedicaSafe buprenorphine dispensing device immediately after an on-site intake at a community supervision office and continue such treatment until they are transitioned to community buprenorphine treatment | Drug | BBT |
| Treatment as usualAlso: TAUParticipants will receive a referral to buprenorphine treatment in the community | Other | TAU |
Primary outcome
opioid use
Time frame: 12 months
illicit opioid drug test (oral saliva) results
10 secondary outcomes
treatment adherence
Time frame: 12 months
treatment adherence
Time frame: 12 months
opioid use days
Time frame: 12 months
health-related quality of life
Time frame: 12 months
health-related quality of life
Time frame: 12 months
HIV risk behaviors
Time frame: 12 months
HIV risk behaviors
Time frame: 12 months
criminal activity
Time frame: 12 months
re-arrest
Time frame: 12 months
re-incarceration
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
- Individual participant dataSharing planned: Yes. FRI is committed to the open and timely dissemination of research outcomes. Investigators in the proposed activity recognize that promising new methods and strategies may arise during the course of the research. Fri will abide by the principles for sharing research resources as described by NIH in "Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources. Working with the research community, as well as the federal funding agency, FRI will serve the scientific community at large by sharing ideas and software to ensure that new knowledge benefits society. Our goals are to disseminate new ideas so the public can benefit from discoveries, and to generate new ideas for research and education. Any data shared will be de-identified and follow the regulations set forth in applicable Human Subjects Protection Guidelines.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Buprenorphine/Naloxone and Treatment as usual in people with Opioid Use, run by Friends Research Institute, Inc. at 1 site 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 4 inclusion and 7 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: paused, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
opioid use (time frame: 12 months). 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 3 Feb 2026.