Clinical Trial: BUPrenorphine Facilitated Access and Supportive Treatment --AIM 3

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: BUPrenorphine Facilitated Access and Supportive Treatment--AIM 3

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 Summary:

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.

Current Primary Outcome: Initiation of buprenorphine treatment [ Time Frame: At 180 days post enrollment ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Opioid use (self-reported) [ Time Frame: At 45 days post enrollment ]
  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).
• Opioid use (urine drug testing) [ Time Frame: At 45 days post enrollment ]
  Participants will complete urine drug testing at study enrollment and at 45 days follow-up, assessing for any opioid use (opiates, oxycodone, methadone, buprenorphine).
• Criminal activity [ Time Frame: At 45 days post enrollment ]
  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).

Original Secondary Outcome: Same as current

Information By: Montefiore Medical Center

Dates:
Date Received: August 12, 2016
Date Started: September 2016
Date Completion: August 2017
Last Updated: September 12, 2016
Last Verified: September 2016