Buprenorphine for Probationers and Parolees: Bridging the Gap Into Treatment

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.

Study Overview

• Status: Recruiting
• Conditions: Opioid Use
• Intervention / Treatment: Other: Treatment as usual; Drug: Buprenorphine/Naloxone

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 Type: Interventional
• Enrollment (Estimated): 320
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Michael S Gordon, DPA; Phone Number: 251 410-837-3977; Email: mgordon@friendsresearch.org
• Study Contact Backup: Name: Frank J Vocci, PhD; Phone Number: 255 410-837-3977; Email: fvocci@friendsresearch.org

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21202
      • Recruiting
      • Division of Parole & Probation
      • Contact: Michael Gordon; Phone Number: 251 410-837-3977; Email: mgordon@friendsresearch.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Subject must provide written informed consent prior to the conduct of any study-related procedures
2. Male or female, 18-65 years of age, inclusive
3. Be on parole or probation for at least the next 4 months
4. 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].

Exclusion Criteria:

1. Current medical condition that may prevent the participant from safely participating in the study as determined by medical evaluation
2. Current psychosis or suicidal ideation
3. Cognitive disorders that prevent the participant from passing a study enrollment quiz
4. Any pending legal action that would interrupt study participation (eg, pending incarceration, probation/parole revocation, unadjudicated charges)
5. Exposure to any investigational drug within 8 weeks of screening
6. Current use benzodiazepines (such as Valium, Xanax and other sedatives), either prescribed or illicitly obtained
7. Currently enrolled in a methadone maintenance treatment program or taking long-acting naltrexone.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: TAU; Participants will receive a referral to buprenorphine treatment in the community.	Other: Treatment as usual; Participants will receive a referral to buprenorphine treatment in the community; Other Names: TAU
Experimental: 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	Drug: Buprenorphine/Naloxone; 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; Other Names: BBT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
opioid use	illicit opioid drug test (oral saliva) results	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
treatment adherence	entered community based treatment	12 months
treatment adherence	number of days receiving opioid treatment	12 months
opioid use days	number of days using illicit opioids	12 months
health-related quality of life	physical health using the SF-12 Health Survey	12 months
health-related quality of life	mental health using the SF-12 Health Survey	12 months
HIV risk behaviors	sexual behavior using the Risk Assessment Battery (RAB)	12 months
HIV risk behaviors	needle use or sharing using the Risk Assessment Battery (RB)	12 months
criminal activity	criminal activity days	12 months
re-arrest	time to re-arrest	12 months
re-incarceration	time to re-incarceration	12 months

Collaborators and Investigators

• Sponsor: Friends Research Institute, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: July 20, 2018
• First Submitted That Met QC Criteria: July 31, 2018
• First Posted (Actual): August 6, 2018

Study Record Updates

• Last Update Posted (Actual): March 7, 2024
• Last Update Submitted That Met QC Criteria: March 6, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Narcotic Antagonists; Buprenorphine; Naloxone; Buprenorphine, Naloxone Drug Combination
• Other Study ID Numbers: FRI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: At completion of the study.
• IPD Sharing Access Criteria: Contact Dr. Michael Gordon Friends Research Institute
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes