BUPrenorphine Facilitated Access and Supportive Treatment --AIM 3

NCT02902835 | Terminated

• 2 other identifiers: 2016-6559K23DA034541
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid-related Disorders

Keywords

Buprenorphine treatment; Incarceration; Linkage Intervention; Opioid use disorder

Outcome Measures

Primary Outcomes (1)

• Initiation of buprenorphine treatment

  Initiation of buprenorphine treatment within 180 days of study enrollment will be confirmed by reviewing the patient's medical records. Participants will sign a release for protected health information in order to confirm buprenorphine induction and visits. Initiation of buprenorphine treatment will be defined as receiving one or more prescription for buprenorphine or buprenorphine-naloxone.

  At 180 days post enrollment

Secondary Outcomes (3)

• Opioid use (self-reported)

  At 45 days post enrollment

• Opioid use (urine drug testing)

  At 45 days post enrollment

• Criminal activity

  At 45 days post enrollment

Study Arms (2)

Referral to treatment (Control)

ACTIVE COMPARATOR

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

Behavioral: Referral to treatment

BUP-FAST Intervention

EXPERIMENTAL

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

Behavioral: BUP_FAST

Interventions

BUP_FAST BEHAVIORAL

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

BUP-FAST Intervention

Referral to treatment BEHAVIORAL

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

Referral to treatment (Control)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Current buprenorphine or methadone maintenance treatment
• Pregnancy

Sponsors & Collaborators

• Montefiore Medical Center: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: August 12, 2016
• First Posted: September 16, 2016
• Study Start: September 1, 2016
• Primary Completion: June 30, 2018
• Study Completion: June 30, 2018
• Last Updated: September 13, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)