OPTIMIZING PATIENT CENTERED-CARE: A PRAGMATIC RANDOMIZED CONTROL TRIAL COMPARING MODELS OF CARE IN THE MANAGEMENT OF PRESCRIPTION OPIOID MISUSE (OPTIMA)
The use of prescription opioid medications has dramatically increased in recent years in Canada, leading to a rise in opioid misuse and related harms such as hospitalization and deaths due to overdose. The prevention and treatment of opioid use disorders has become an urgent public health priority which requires an evidence-based response that best reflects the needs of individuals with opioid use disorders and the community.
The Canadian Institutes of Health Research – Institute of Neurosciences, Mental Health, and Addiction recently launched Phase I of the Canadian Research Initiative in Substance Misuse (CRISM), a national research consortium in substance misuse modeled after the National Institute on Drug Abuse’s Clinical Trial Network. This consortium spans four regional nodes: British Columbia, the Prairies, Ontario, and Québec-Maritimes.
The OPTIMA study is the first national clinical trial through CRISM. This trial aims to evaluate two opioid agonist treatment models of care for the treatment of prescription opioid use disorders: methadone, the current standard of care in Canada; and buprenorphine/naloxone, the therapy of choice in the United States and other jurisdictions internationally. In order to improve patient care the study will address real-world treatment conditions, including strict regulations for methadone dosing (i.e., dispensed daily at a pharmacy) vs. flexible take-home dosing for buprenorphine/naloxone.
- The primary objective is to study the overall use of opioids over the 24-week study.
- Secondary objectives include studying retention in treatment, medication adherence, safety, treatment satisfaction, and patient engagement.
The OPTIMA study is designed with the intention to support patient-provider decision-making and evaluate health related outcomes with the overall goal of improving treatment outcomes through enhancing patient-centered approaches in clinical care.
- Canadian Institutes of Health Research (CIHR)
INTERESTED IN FINDING OUT MORE ABOUT OPTIMA?
To learn more about OPTIMA, please contact us.
Jill Fikowski, Clinical Trials Coordinator