CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 272 enrolled
Drug / intervention
Methadone +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03033732
NCT03033732Phase 4Completed
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Optimizing Patient Centered-Care: A Pragmatic Randomized Control Trial Comparing Models of Care in the Management of Prescription Opioid Misuse (OPTIMA Trial)

Didier Jutras Aswad·interventional·Posted Jan 27, 2017·Updated Jun 16, 2021

In Brief

A Phase 4 clinical trial evaluating Methadone and Buprenorphine-Naloxone for Opioid Use Disorder. Completed, enrolled 272 participants across 7 sites.

Detailed Summary

This trial evaluates two standard of care treatments for opioid addiction: methadone and buprenorphine/naloxone. In order to improve patient care, the study will address real-world treatment conditions, including strict regulations for methadone dosing (i.e. initially dispensed daily at the pharmacy until stabilisation) vs. flexible take-home dosing for buprenorphine/naloxone. The OPTIMA study is designed with the intention to support patient-provider decision-making and evaluate health related outcomes with the overall aim of improving treatment outcomes through enhancing patient-centered approaches in clinical care.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOpioid Use Disorder
CountriesCanada
CollaboratorsCanadian Institutes of Health Research (CIHR)

Timeline

Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedJan 27, 2017
Enrollment StartOct 2, 2017
Primary CompletionMar 31, 2020
Study CompletionDec 31, 2020
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 9.4 years ago

Interventions

Methadonedrug

Methadone is a synthetic analgesic drug used as a substitute drug in the treatment of opioid use disorder. Methadone is administered via strict daily witnessed ingestion.

Buprenorphine-Naloxonedrug

Buprenorphine/Naloxone is an opioid agonist treatment used to treat opioid use disorder. Buprenorphine/Naloxone is administered via flexible take home dosing once the patient has reached stabilization as per physician discretion.