drugset / Trial / NCT05594121
Monthly Versus Daily Buprenorphine Formulations for Treatment of Opiate Use Disorder
RandomizedParallel-groupSingle-blindTreatment
Summary
Opioid use disorder and opioid-related deaths are increasing across Canada. The mainstay of medical treatment includes either full (methadone) or partial (buprenorphine) opioid agonist therapy. In Canada, there are 2 buprenorphine formulations, an immediate-release (Suboxone) and extended-release(Sublocade). These treatments have been shown to be equivalent for medication adherence and treatment retention. However, Sublocade costs 8-times more, and 50% of patients must pay out-of-pocket if they prefer this treatment option. This study is needed to demonstrate the superior benefits of Sublocade on important clinical outcomes to demonstrate its cost-effectiveness and justify expanded insured access across Canada.
Timeline
- Start
- 2022-12
- Primary completion
- 2023-12
- Completion
- 2024-12
Publications
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Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Buprenorphine | Other / unclassified | 100 mg | Subcutaneous |
| Comparator | Buprenorphine | Other / unclassified | — | Other |
| Comparator | Naloxone | Small molecule | — | Other |