BUPrenorphine Facilitated Access and Supportive Treatment --AIM 3

NCT ID: NCT02902835

Last Updated: 2018-09-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-01
• Study Completion Date: 2018-06-30

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.

Conditions

Opioid-related Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Referral to treatment (Control)

The control group will receive a referral to buprenorphine treatment by the research staff.

Group Type: ACTIVE_COMPARATOR

Referral to treatment

Intervention Type: BEHAVIORAL

Participants will receive a pamphlet describing the buprenorphine treatment program at a Montefiore community health center.

BUP-FAST Intervention

Thirty-six participants will each be paired with a trained peer mentor who will provide the BUP-FAST intervention.

Group Type: EXPERIMENTAL

BUP_FAST

Intervention Type: BEHAVIORAL

Peer mentorship including: buprenorphine education, identifying buprenorphine providers, accompaniment at appointments, and psychosocial support (via outreach phone calls)

Interventions

BUP_FAST

Peer mentorship including: buprenorphine education, identifying buprenorphine providers, accompaniment at appointments, and psychosocial support (via outreach phone calls)

Intervention Type: BEHAVIORAL

Referral to treatment

Participants will receive a pamphlet describing the buprenorphine treatment program at a Montefiore community health center.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Montefiore Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Aaron D. Fox

Assistant Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Montefiore Medical Center

The Bronx, New York, United States

Countries

United States

Other Identifiers

K23DA034541

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2016-6559

Identifier Type: -

Identifier Source: org_study_id