Monthly Versus Daily Buprenorphine Formulations for Treatment of Opiate Use Disorder (NCT05594121) | Clinical Trial Compass
UnknownPhase 4
Monthly Versus Daily Buprenorphine Formulations for Treatment of Opiate Use Disorder
Canada90 participantsStarted 2022-12
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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