drugset / Trial / NCT05594121

Monthly Versus Daily Buprenorphine Formulations for Treatment of Opiate Use Disorder

NCT05594121

Phase 4 Unknown 90 enrolled Royal Victoria Hospital, Canada
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

Drugs

EvaluationDrugModalityDoseRoute
Comparator Buprenorphine Other / unclassified 100 mg Subcutaneous
Comparator Buprenorphine Other / unclassified Other
Comparator Naloxone Small molecule Other

Indications