Buprenorphine for Probationers and Parolees: Bridging the Gap Into Treatment

Opioid Use Clinical Trial

Official title:

Buprenorphine for Probationers and Parolees: Bridging the Gap Into Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03616236
• Other study ID #: FRI
• Status: Recruiting
• Phase: Phase 3
• Start date: July 1, 2022
• Est. completion date: June 30, 2026

Study information

• Verified date: March 2024
• Source: Friends Research Institute, Inc.
• Contact: Michael S Gordon, DPA
• Phone: 410-837-3977
• Email: mgordon[@]friendsresearch.org
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 320
• Est. completion date: June 30, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Opioid Use

Intervention

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:
• Treatment as usual
Participants will receive a referral to buprenorphine treatment in the community

Locations

Country	Name	City	State
United States	Division of Parole & Probation	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Friends Research Institute, Inc.

Country where clinical trial is conducted

United States, 

Outcome

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