Toronto, ON (February 02, 2026) — Collaborative research with the Centre for Addiction and Mental Health (CAMH) has been instrumental in rapidly transforming the delivery of a key opioid use disorder treatment in Canada, significantly enhancing access, adherence, and outcomes for individuals at highest risk of overdose.
Health Canada has updated the product labelling for extended-release injectable buprenorphine (SUBLOCADE)—a once-monthly injection that delivers a steady dose of buprenorphine, a medication proven to reduce opioid cravings, opioid use and overdose risk. The label change reflects new evidence that allows patients, particularly those who use fentanyl, to transition more quickly and safely onto long-acting treatment. This represents an unusually fast translation of research into practice and will help save lives by keeping people engaged in treatment during the most vulnerable period of care.
“Canada remains in the midst of an unprecedented opioid crisis, driven largely by the toxicity and unpredictability of fentanyl,” said Dr. Bernard Le Foll, clinician-scientist at CAMH and co-author on the research. “About 7,000 Canadians continue to die each year from opioid-related overdoses, and many more struggle to stay connected to care. Making it easier for people at highest risk to start and remain on effective treatment is not just good medicine, it’s essential to preventing avoidable deaths.”
The first study underpinning the product label change, titled Rapid vs Standard Induction to Injectable Extended-Release Buprenorphine: A Randomized Clinical Trial, published in JAMA Network Open in October 2025 and examined whether people with opioid use disorder, many of whom were using fentanyl, could be safely transitioned more rapidly from daily transmucosal buprenorphine to monthly injectable buprenorphine. The randomized clinical trial found that rapid induction—administration of a single dose of 4-mg transmucosal buprenorphine followed by a same-day SUBLOCADE injection—was just as safe as standard induction—which is at least seven days of transmucosal buprenorphine dose adjustments prior to the first injection of SUBLOCADE—and rapid induction resulted in better early treatment retention.
This study shows shortened, streamlined induction approach may help more people stay in care during the critical early weeks, without increasing withdrawal symptoms or serious adverse events. These findings are especially important in the fentanyl era, where traditional induction methods often lead to early disengagement from care, and they provide strong evidence to support updates to opioid use disorder treatment guidelines.
“This research shows we can safely remove unnecessary barriers to treatment,” said Dr. Rajinder Shiwach, senior author of the first paper. “By getting people onto long-acting buprenorphine faster, we can stabilize patients sooner, reduce overdose risk, and modernize opioid treatment to reflect today’s drug supply—both in the U.S. and internationally.”
An additional publication appeared in JAMA Network Open in December 2025, titled Comparison of Extended-Release Buprenorphine Doses for Treating High-Risk Opioid Use: A Randomized Clinical Trial. Following rapid or standard induction of extended-release injectable buprenorphine, participants received an additional 300 mg dose one week after the first dose and were randomized to 8 additional monthly doses of either 100 mg and 300 mg. This study publication shows that both doses improved opioid abstinence and were well tolerated. In a post hoc analysis, people who used fentanyl daily or ≥14 times weekly achieved better outcomes on the higher maintenance dose. Together, the two studies support a more personalized, fentanyl-responsive approach to treatment—one that prioritizes rapid access and dose optimization for those at greatest risk.
CAMH brings decades of leadership in addiction science and clinical care. Each year, CAMH provides treatment to thousands of people with opioid use disorder through specialized outpatient clinics, hospital-based services, emergency care pathways and community partnerships. CAMH clinicians were among the earliest in Canada to implement injectable opioid agonist therapies and continue to lead national efforts to expand access to evidence-based, life-saving care.
This study was funded by Indivior. Drs. Le Foll and Shiwach were members of the Steering Board for this clinical trial for Indivior.
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About the Centre for Addiction and Mental Health (CAMH)
The Centre for Addiction and Mental Health (CAMH) is Canada's largest mental health and addiction teaching hospital and a world leading research centre in this field. CAMH combines clinical care, research, education, policy development and health promotion to help transform the lives of people affected by mental illness and addiction. CAMH is fully affiliated with the University of Toronto and is a Pan American Health Organization/World Health Organization Collaborating Centre. For more information, please visit camh.ca or follow @CAMHnews on Bluesky and LinkedIn.
About SUBLOCADE
For additional SUBLOCADE information from the Product Monograph, please visit Health Canada at https://pdf.hres.ca/dpd_pm/00048406.PDF .
Media Contact: media@camh.ca