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| Name | Class |
|---|---|
| Indivior Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sublocade | The only group consists of participants with moderate to severe OUD who will be starting treatment with extended-release injectable buprenorphine as part of standard of care. While individual treatment regimens may vary, these will often consist of 2 once-monthly 300 mg subcutaneous injections followed by 4 once-monthly 100 mg subcutaneous injections. However, participants may receive once-monthly 300 mg subcutaneous injections in place of 100 mg subcutaneous injections for as many months as is deemed necessary by their prescribing physician. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number 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. | 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). | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 weeks |
| Safety monitoring |
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Inclusion Criteria:
Participants must meet ALL the following criteria to be eligible to participate for the study:
Exclusion Criteria:
Participants will be excluded from the study if ANY of the following criteria are met:
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Approximately 40 eligible participants are planned to be enrolled into the study. Interested individuals must meet all of the inclusion criteria and none of the exclusion criteria to be eligible for the study.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Piper Dickhout, BSc | Contact | 604-364-7006 | piper.dickhout@bccsu.ubc.ca |
| Name | Affiliation | Role |
|---|---|---|
| M. Eugenia Socias, MD, MSc. | Assistant Professor, Department of Medicine, University of British Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rapid Access Addiction Clinic (RAAC), St. Paul's Hospital | Recruiting | Vancouver | British Columbia | V6Z 1Y6 | Canada |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| D000083682 | Opiate Overdose |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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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. |
| 24 weeks |
| D062787 | Drug Overdose |
| D063487 | Prescription Drug Misuse |
| D000076064 | Drug Misuse |