- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04815590
Extended-release Injectable Buprenorphine for Individuals at High Risk of Overdose (FASTER-BUP)
Pilot Study to Assess the Feasibility, Efficacy and Safety of Extended-release Injectable Buprenorphine for the Treatment of Opioid Use Disorder Among Individuals at High Risk of Overdose
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Piper Dickhout, BSc
- Phone Number: 604-364-7006
- Email: piper.dickhout@bccsu.ubc.ca
Study Locations
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British Columbia
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Vancouver, British Columbia, Canada, V6Z 1Y6
- Recruiting
- Rapid Access Addiction Clinic (RAAC), St. Paul's Hospital
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Contact:
- Piper Dickhout, BSc
- Phone Number: 604-364-7006
- Email: piper.dickhout@bccsu.ubc.ca
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Sub-Investigator:
- Seonaid Nolan, MD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
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 Criteria:
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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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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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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of XR-BUP injections received
Time Frame: 24 weeks
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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.
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24 weeks
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Proportion of treatment-engaged visits per participant
Time Frame: 24 weeks
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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).
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24 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of opioid free weeks
Time Frame: 24 weeks
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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.
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24 weeks
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Safety monitoring
Time Frame: 24 weeks
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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
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: M. Eugenia Socias, MD, MSc., Assistant Professor, Department of Medicine, University of British Columbia
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BCCSU-004
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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