BUPrenorphine Facilitated Access and Supportive Treatment --AIM 3 (BUPFAST)
Primary Purpose
Opioid-related Disorders
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
BUP_FAST
Referral to treatment
Sponsored by
About this trial
This is an interventional treatment trial for Opioid-related Disorders focused on measuring Buprenorphine treatment, Incarceration, Linkage Intervention, Opioid use disorder
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Current buprenorphine or methadone maintenance treatment
- Pregnancy
Sites / Locations
- Montefiore Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Referral to treatment (Control)
BUP-FAST Intervention
Arm Description
The control group will receive a referral to buprenorphine treatment by the research staff.
Thirty-six participants will each be paired with a trained peer mentor who will provide the BUP-FAST intervention.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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).
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).
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).
Full Information
NCT ID
NCT02902835
First Posted
August 12, 2016
Last Updated
September 11, 2018
Sponsor
Montefiore Medical Center
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT02902835
Brief Title
BUPrenorphine Facilitated Access and Supportive Treatment --AIM 3
Acronym
BUPFAST
Official Title
BUPrenorphine Facilitated Access and Supportive Treatment--AIM 3
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Terminated
Why Stopped
Grant Funding Ended
Study Start Date
September 1, 2016 (Actual)
Primary Completion Date
June 30, 2018 (Actual)
Study Completion Date
June 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Montefiore Medical Center
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-related Disorders
Keywords
Buprenorphine treatment, Incarceration, Linkage Intervention, Opioid use disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Referral to treatment (Control)
Arm Type
Active Comparator
Arm Description
The control group will receive a referral to buprenorphine treatment by the research staff.
Arm Title
BUP-FAST Intervention
Arm Type
Experimental
Arm Description
Thirty-six participants will each be paired with a trained peer mentor who will provide the BUP-FAST intervention.
Intervention Type
Behavioral
Intervention Name(s)
BUP_FAST
Intervention Description
Peer mentorship including: buprenorphine education, identifying buprenorphine providers, accompaniment at appointments, and psychosocial support (via outreach phone calls)
Intervention Type
Behavioral
Intervention Name(s)
Referral to treatment
Intervention Description
Participants will receive a pamphlet describing the buprenorphine treatment program at a Montefiore community health center.
Primary Outcome Measure Information:
Title
Initiation of buprenorphine treatment
Description
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.
Time Frame
At 180 days post enrollment
Secondary Outcome Measure Information:
Title
Opioid use (self-reported)
Description
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).
Time Frame
At 45 days post enrollment
Title
Opioid use (urine drug testing)
Description
Participants will complete urine drug testing at study enrollment and at 45 days follow-up, assessing for any opioid use (opiates, oxycodone, methadone, buprenorphine).
Time Frame
At 45 days post enrollment
Title
Criminal activity
Description
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).
Time Frame
At 45 days post enrollment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Current buprenorphine or methadone maintenance treatment
Pregnancy
Facility Information:
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
BUPrenorphine Facilitated Access and Supportive Treatment --AIM 3
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