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Monthly Versus Daily Buprenorphine Formulations for Treatment of Opiate Use Disorder

NCT05594121 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2022-10-26

No results posted yet for this study

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.

Conditions

  • Moderate to Severe Opioid Use Disorder

Interventions

DRUG

Extended Release Subcutaneous Buprenorphine

Monthly subcutaneous injections of long-acting buprenorphine

DRUG

Immediate Release Sublingual Buprenorphine

Daily sublingual fast-acting buprenorphine

Sponsors & Collaborators

  • Royal Victoria Hospital, Canada

    lead OTHER

Principal Investigators

  • Philip Wong, MN · Royal Victoria Regional Health Centre

  • Giulio DiDiodato, PhD · Royal Victoria Regional Health Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-31
Primary Completion
2023-12-31
Completion
2024-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05594121 on ClinicalTrials.gov