Clinical trial NCT03616236: Buprenorphine for Probationers and Parolees: Bridging the Gap Into Treatment
Official title: Buprenorphine for Probationers and Parolees: Bridging the Gap Into Treatment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Opioid Use
Lead sponsor: Friends Research Institute, Inc.
Sponsor class: OTHER
First posted: 2018-08-06
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: opioid use
timeFrame: 12 months
Secondary outcomes:
measure: treatment adherence
timeFrame: 12 months
measure: treatment adherence
timeFrame: 12 months
measure: opioid use days
timeFrame: 12 months
measure: health-related quality of life
timeFrame: 12 months
measure: health-related quality of life
timeFrame: 12 months
measure: HIV risk behaviors
timeFrame: 12 months
measure: HIV risk behaviors
timeFrame: 12 months
measure: criminal activity
timeFrame: 12 months
measure: re-arrest
timeFrame: 12 months
measure: re-incarceration
timeFrame: 12 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Division of Parole & Probation
state: Maryland
Study officials:
References: