BUPrenorphine Facilitated Access and Supportive Treatment --AIM 3

Opioid-related Disorders Clinical Trial

— BUPFAST  

Official title:

BUPrenorphine Facilitated Access and Supportive Treatment--AIM 3

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02902835
• Other study ID #: 2016-6559
• Secondary ID: K23DA034541
• Status: Terminated
• Phase: N/A
• Start date: September 1, 2016
• Est. completion date: June 30, 2018

Study information

• Verified date: September 2018
• Source: Montefiore Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: June 30, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Opioid-related Disorders

Intervention

Behavioral:
• BUP_FAST
Peer mentorship including: buprenorphine education, identifying buprenorphine providers, accompaniment at appointments, and psychosocial support (via outreach phone calls)
• Referral to treatment
Participants will receive a pamphlet describing the buprenorphine treatment program at a Montefiore community health center.

Locations

Country	Name	City	State
United States	Montefiore Medical Center	Bronx	New York

Sponsors (2)

Lead Sponsor	Collaborator
Montefiore Medical Center	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Opioid use (self-reported)	Participants will complete interviews (adapted Addiction Severity Index) at study enrollment and at 45 days follow-up, self-reporting opioid use (heroin, opioid analgesics, methadone, illicit buprenorphine).	At 45 days post enrollment
Secondary	Opioid use (urine drug testing)	Participants will complete urine drug testing at study enrollment and at 45 days follow-up, assessing for any opioid use (opiates, oxycodone, methadone, buprenorphine).	At 45 days post enrollment
Secondary	Criminal activity	Participants will complete interviews (Addiction Severity Index) at study enrollment and 45 days follow-up, self-reporting involvement in criminal activities in the previous 30 days (# days with involvement).	At 45 days post enrollment