Clinical trial NCT02902835: BUPrenorphine Facilitated Access and Supportive Treatment --AIM 3
Official title: BUPrenorphine Facilitated Access and Supportive Treatment--AIM 3
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Opioid-related Disorders
Keywords: Buprenorphine treatment
Incarceration
Linkage Intervention
Opioid use disorder
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2016-09-16
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this study is to test whether peer mentors (i.e., individuals with past opioid addiction and prior incarceration) can facilitate entrance into buprenorphine (Suboxone) treatment for individuals with opioid use disorder who were recently released from jail or prison. In order to test whether it is helpful to have peer mentors paired with recently released individuals, the investigators will conduct an 18 month study, recruiting 72 formerly incarcerated individuals and assigning them by chance selection (like flipping a coin) to either a group that will receive peer mentorship or a group that will receive a referral to a community clinic.

Detailed description: BUPrenorphine Facilitated Access and Supportive Treatment (BUP-FAST) is a peer mentorship intervention in which trained peer mentors will link formerly incarcerated individuals with opioid use disorder to addiction treatment (i.e. buprenorphine maintenance treatment) following release from incarceration. The current study is a pilot randomized control trial evaluating the effectiveness and feasibility of the peer mentorship intervention.

The investigators are conducting this study due to the high rates of relapse to opioid use following release from prison (up to 75% within 3 months) and difficulty that some formerly incarcerated individuals report in accessing effective treatments for opioid use disorder. The investigators hypothesize that having peer mentors - who themselves have experienced incarceration and have had success with buprenorphine treatment for opioid use disorder - assisting formerly incarcerated individuals in seeking treatment will result in higher rates of linkage to care in comparison to referral to a community health center for buprenorphine treatment.

In this 18-month randomized control trial of the BUP-FAST intervention, the investigators will recruit 72 formerly incarcerated individuals with opioid use disorder; half will then be randomized to receive the BUP-FAST intervention (peer mentorship); and the other half (control) will receive referral to a community health center for assessment for buprenorphine treatment. Medication will not be provided as part of this study. Participants will only receive buprenorphine treatment if they meet appropriate medical criteria after assessment at the community health center.

Eligibility criteria: Inclusion Criteria:

1. Current or prior (at the time of incarceration) opioid use disorder by DSM-V criteria
2. ≥ 18 years old
3. Fluent in English or Spanish
4. Released from incarceration in the last 4 weeks

Exclusion Criteria:

1. Current buprenorphine or methadone maintenance treatment
2. Pregnancy

Primary outcomes:
measure: Initiation of buprenorphine treatment
timeFrame: At 180 days post enrollment
Secondary outcomes:
measure: Opioid use (self-reported)
timeFrame: At 45 days post enrollment
measure: Opioid use (urine drug testing)
timeFrame: At 45 days post enrollment
measure: Criminal activity
timeFrame: At 45 days post enrollment
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
References: