Monthly Versus Daily Buprenorphine Formulations for Treatment of Opiate Use Disorder

• Status: Not yet recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Royal Victoria Hospital, Canada
• Treatments: Buprenorphine

Criteria

Inclusion Criteria:

• Ages 18 to 65 years old

• OAT indicated for moderate- to severe-OUD

• Attend a RAAM clinic in the North Simcoe Muskoka Local Health Integrated Network for opiate substitution treatment

• Successfully completed induction and stabilization OAT with Suboxone® tablet or film defined as receiving 8mg/2mg to 24mg/6mg of Suboxone® for ≥7 days with no evidence of allergic reaction to Suboxone®, Clinical Opiate Withdrawal Scale (COWS) score ≤12 (scale:0-48) for ≥24 hours, and Opiate Craving Visual Analog Scale (VAS) score ≤20 (scale:0-100)) for ≥24 hours

• Must have an active Ontario Health Insurance Plan number

• Must have a telephone that can receive calls, text messages or emails

• Must have drug insurance coverage for either medication for duration of study or demonstrate ability to pay for the drug out-of-pocket

Exclusion Criteria:

• Receiving any investigational drug for OUD in previous 4 weeks

• Congenital long QTc syndrome or QTc prolongation at baseline by electrocardiogram (QTc ≥450 milliseconds in men and QTc ≥470 milliseconds in women)

• Pregnant or lactating women

• Women of childbearing potential who are not using an effective and reliable method of contraception