A Pragmatic Randomized Control Trial Comparing Models of Care in the Management of Prescription Opioid Misuse

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.

Conditions

• Opioid Use Disorder

Interventions

DRUG

Methadone

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.

DRUG

Buprenorphine-Naloxone

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.

Sponsors & Collaborators

• Canadian Institutes of Health Research (CIHR)

  collaborator OTHER_GOV

• Didier Jutras Aswad

  lead OTHER

Principal Investigators

• Didier Jutras Aswad, MD · Canadian Research Initiative in Substance Misuse

• Maria E Socias, MD · British Columbia Centre on Substance Use

• Keith Ahamad, MD · British Columbia Centre on Substance use

• Bernard LeFoll, PhD · Centre for Addiction and Mental Health

• Ron Lim, MD · University of Calgary

• Julie Bruneau, MD · Centre hospitalier de l'Université de Montréal (CHUM)

• Evan Wood, MD · British Columbia Centre on Substance Use

• Cameron Wild, PhD · University of Alberta

• Jurgen Rehm, PhD · Centre for Addiction and Mental Health

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

64 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-10-02

Primary Completion

2020-03-31

Completion

2020-12-31

Countries

• Canada

Study Locations