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 for overdose (OD).
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 participants with moderate to severe OUD starting treatment with XR-BUP as part of standard of care will be followed.
Study Type
OBSERVATIONAL
Enrollment
40
Rapid Access Addiction Clinic (RAAC), St. Paul's Hospital
Vancouver, British Columbia, Canada
RECRUITINGNumber of XR-BUP injections received
The primary outcome for this study will be retention in treatment, defined as having received the six scheduled XR-BUP injections and completed the EOS/Early Termination visit.
Time frame: 24 weeks
Proportion of treatment-engaged visits per participant
Proportion of treatment-engaged visits per participant will be calculated as the number of received XR-BUP injections divided by the number of scheduled injections (i.e., six).
Time frame: 24 weeks
Percentage of opioid free weeks
Suppression of illicit opioid use will be measured as the percentage of opioid-free weeks during the active treatment period (Visit 2 to Visit 8), using a combination of Urine Drug Test (UDT) results and self-reported illicit opioid use.
Time frame: 24 weeks
Safety monitoring
Descriptive statistics will be used for all safety analysis variables. No formal inferential tests will be performed on safety data. The incidence of all AEs will be summarized by body system, severity, seriousness, and relationship to the study drug using MedDRA. SAEs will be tabulated by patient. Descriptive statistics will be reported for injection site grading.
Time frame: 24 weeks
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