Study Stopped
Unable to recruit from study sites.
Buprenorphine for Probationers and Parolees: Bridging the Gap Into Treatment
1 other identifier
interventional
320
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jul 2022
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 20, 2018
CompletedFirst Posted
Study publicly available on registry
August 6, 2018
CompletedStudy Start
First participant enrolled
July 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 30, 2026
February 3, 2026
January 1, 2026
4.2 years
July 20, 2018
January 30, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
opioid use
illicit opioid drug test (oral saliva) results
12 months
Secondary Outcomes (10)
treatment adherence
12 months
treatment adherence
12 months
opioid use days
12 months
health-related quality of life
12 months
health-related quality of life
12 months
- +5 more secondary outcomes
Study Arms (2)
TAU
ACTIVE COMPARATORParticipants will receive a referral to buprenorphine treatment in the community.
BBT
EXPERIMENTALParticipants 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
Interventions
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
Participants will receive a referral to buprenorphine treatment in the community
Eligibility Criteria
You may qualify if:
- 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 \[Note: parolees not currently physically dependent will be allowed in the study\].
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Division of Parole & Probation
Baltimore, Maryland, 21202, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 20, 2018
First Posted
August 6, 2018
Study Start
July 1, 2022
Primary Completion (Estimated)
August 31, 2026
Study Completion (Estimated)
December 30, 2026
Last Updated
February 3, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ANALYTIC CODE
- Time Frame
- At completion of the study.
- Access Criteria
- Contact Dr. Michael Gordon Friends Research Institute
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.