About the OPTIMA Study

We know the OPTIMA study was about searching for more flexible and person-centred approaches to OUD care but how did it do this? Learn about the who, what, where, when and why of the trial below. Or, listen to the live stream recording of the Hard Knox Talks podcast where host Daniel Hearn sits down with the Principal Investigator of the trial Didier Jutras-Aswad to chat all things OPTIMA.

The 5 W’s of the Trial

  • The OPTIMA trial compared the effectiveness of flexible Buprenorphine/naloxone models of care (I.e., being able to take doses home sooner) vs. standard methadone at reducing opioid use for individual with POUD in real-life clinical practice settings. OPTIMA was a multi-centre, open-label, 2-arm, non-inferiority, randomized, pragmatic trial.

  • Treatment-seeking adult aged 18-64, diagnosed with an opioid use disorder related to prescription-type opioids (POUD) and requiring Opioid Agonist Treatment (OAT). Participants were excluded if:

    • They had an unstable psychiatric or medical condition that would prevent safe participation

    • Experienced pain requiring opioids

    • Used heroin as the most frequent opioid in the past 30 days

    • Were enrolled in OAT 30 days prior to screening

    • Took medications interacting with study medications

    • Had a history of severe adverse reaction to study medications

    • Had pending legal action preventing study completion

    • Pregnant and breastfeeding women and women planning to conceive

  • The OPTIMA trial was launched in 2017 and recruitment took place up until March 23, 2020. The COVID-19 pandemic led the study team (after consulting the DSMB) to stop recruitment with 272 randomized participants out of the 276 initially planned.

  • The trial was conducted at 7 sites in BC (RAAC, PHS), Alberta (ODP Clinic), Ontario (CAMH) and Quebec (CHUM, CRAN).

  • Up until now, studies comparing the efficacy of Suboxone and Methadone were conducted under strict medical surveillance, deemed essential to ensure the safety and efficacy of the therapies. Those receiving such treatment often find this approach restrictive — and many others simply don’t end up receiving it because the requirement to be under supervision limits easy access to it.

    The flexibility of take-home doses offered by Suboxone helps to simplify and facilitate OAT nationally.

How did the study work?

In a nutshell: Participants were randomly assigned to two groups:

  • Half received methadone under close supervision in a pharmacy

  • The other half received buprenorphine with naloxone, which could most often be taken at home

Participants attended follow up visits with the research team every 2 weeks for a total of 24 weeks. During follow-up visits, participants provided urine samples and updated their demographic, substance use and other medical/social health related information.

To learn more about how the trial worked see:

Study Design & Rationale Paper
Methods Factsheet Here