An observational study in Opioid-Use Disorder and Opioid Overdose, sponsored by BC Centre on Substance Use. Status unknown at 1 site in Canada. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2022-11-17.
Sponsored by BC Centre on Substance Use · Observational
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.
70 studies on the registry are indexed under Opiate Overdose; 11 are open to participants now.
This study's planned enrollment of 40 is below the median of 284 across 16 observational studies indexed under Opiate Overdose.
Browse Opiate Overdose studies →BC Centre on Substance Use is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
Compared within Opiate Overdose, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Opioid-Related Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
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
Plan to share: No
No publications or documents are linked to this record.
Started Oct 2022 (actual). Primary completion is estimated for Oct 2023, 12 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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BC Centre on Substance Use