Multi-centre Trial for the Treatment of Methamphetamine use Disorder
Canadian Research Initiative in Substance Matters (CRISM)
Clinical Trial
The Canadian Research Initiative in Substance Matters (CRISM) is a national research consortium funded by the Canadian Institutes of Health Research (CIHR).
With over 1,400 members across five regional nodes—British Columbia, the Prairies, Ontario, Québec, and Atlantic Canada—CRISM accelerates evidence generation and translates research into clinical practice and policy to improve care for people living with substance use disorders.
Modelled in part after the U.S. National Institute on Drug Abuse’s Clinical Trials Network, CRISM supports large-scale, multi-site studies that connect scientific innovation with community-based implementation.
Challenge
Methamphetamine use has surged across Canada, contributing to rising hospitalizations, emergency visits, and overdose deaths. Despite this growing crisis, no approved pharmacological treatments currently exist for methamphetamine use disorder (MUD).
To address this gap, CRISM launched the ASCME Trial: Addition of high-dose Stimulant and engagement-focused Contingency Management for the management of Methamphetamine use disorder. This Phase II, multi-centre randomized controlled trial (RCT) evaluates whether high-dose stimulant therapy and contingency management can improve outcomes for individuals with moderate to severe MUD.
The trial presented complex challenges: managing a controlled substance (lisdexamfetamine) across multiple jurisdictions, coordinating multi-site ethics and regulatory submissions, and engaging a highly stigmatized and hard-to-reach patient population. CRISM required a partner experienced in substance use research, controlled drug regulations, and community-engaged clinical trials to guide operational and regulatory delivery at a national scale.
Solution
Changemark partnered with CRISM to provide comprehensive project management and regulatory affairs support for the ASCME Trial, ensuring consistency, compliance, and coordination across all participating sites.
By integrating regulatory precision with operational leadership, Changemark supports consistent, high-quality trial delivery across CRISM’s network—bridging scientific rigor with practical coordination on the ground.
The project includes:
Project Management
Oversight from trial start-up through active study period
Operational management across five clinical sites (BC, Alberta, Ontario, Québec, and New Brunswick)
Training and oversight for over 40 physicians and site staff
Progress reporting, milestone tracking, and cross-site communications
Regulatory Affairs
Submission and maintenance of Health Canada applications
Safety reporting and documentation oversight across all sites
Alignment with Health Canada regulations and sponsor governance structures
Results
The ASCME Trial launched successfully and is now actively enrolling participants, with completion anticipated in 2026.
Impact to date:
Five clinical sites initiated with full regulatory and ethics approvals
40+ physicians and site staff trained nationwide
Complex regulatory submissions, approvals and manufacturer coordination completed
Ongoing national trial coordination among CRISM partners, including four post-secondary institutions and research centres across the country.
As one of Canada’s first large-scale efforts to evaluate both pharmacological and behavioral treatments for MUD, the ASCME Trial represents a pivotal step toward expanding treatment options and improving care for people living with stimulant use disorder.
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