Status:
UNKNOWN
Extended-release Injectable Buprenorphine for Individuals at High Risk of Overdose
Lead Sponsor:
BC Centre on Substance Use
Collaborating Sponsors:
Indivior Inc.
Conditions:
Opioid-Use Disorder
Opioid Overdose
Eligibility:
All Genders
19+ years
Brief Summary
This pilot study will evaluate the feasibility and clinical utility of extended-release injectable buprenorphine (XR-BUP) for the treatment of opioid use disorder (OUD) among individuals at high-risk ...
Detailed Description
FASTER-BUP is a 24-week observational pilot study evaluating the feasibility and clinical utility of XR-BUP (brand name: Sublocade) for the treatment of OUD among individuals at high-risk of OD. Forty...
Eligibility Criteria
Inclusion
- Participants must meet ALL the following criteria to be eligible to participate for the study:
- Be above 19 years of age;
- Be diagnosed with moderate or severe OUD as evidenced by their approval for treatment with XR-BUP (Sublocade);
- Be at high-risk for recurrent overdose, defined as having experienced a recent non-fatal overdose within the past 6 months (e.g., admission to the emergency department for an overdose OR self-reported OD that required Naloxone administration OR had an overdose where an ambulance arrived at the scene);
- Have a new prescription for XR-BUP, but have not yet initiated treatment;
- Be able and willing to follow study procedures;
- Be able to provide adequate locator information (e.g., phone number and at least one emergency contact);
- Be able and willing to provide written informed consent;
- Be able to understand, communicate and speak with the research staff. Non-English speaking individuals will require a translator to be present during all study visits and during all study activities. The translator will be independent (e.g., not known to the participant to prevent the risk for coercion or misrepresentation).
Exclusion
- Participants will be excluded from the study if ANY of the following criteria are met:
- Be on OAT other than buprenorphine/naloxone in the 7 days prior to screening;
- Be on a stable buprenorphine/naloxone dose for more than 27 days prior to screening;
- Use of an investigational drug in the 30 days prior to screening;
- Incarcerated, pending legal action or other reasons that might prevent completion of the study.
Key Trial Info
Start Date :
October 17 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 17 2023
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04815590
Start Date
October 17 2022
End Date
October 17 2023
Last Update
November 17 2022
Active Locations (1)
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1
Rapid Access Addiction Clinic (RAAC), St. Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 1Y6