ASCME Clinical Trial
Addition of high dose Stimulant and engagement-focused Contingency management for the management of MEthamphetamine use disorder (ASCME): a pan-Canadian multisite randomized controlled trial
Overview
Methamphetamine (“meth”; MA) use in Canada is on the rise. In the past decade, the number of deaths, hospitalizations, and emergency room visits due to MA and other stimulant use has increased across Canada. MA is highly addictive. Withdrawal symptoms include intense cravings, and long-term use can lead to psychosis (such as paranoia and hallucinations), and increased risk of HIV, Hepatitis C, and cardiovascular events (such as heart attack and stroke). Right now, there are no approved treatments for MA use disorder.
There is some early evidence that using high-dose psychostimulants as substitution therapy can be effective against MA use disorder. Studies show that psychostimulants can reduce cravings and improve mental health, and high doses are safe in this population. Contingency management, a type of treatment where a person is given an incentive for achieving certain behaviour change, has been successful in treating substance use disorders. Our stakeholder consultation showed that people with lived experience and clinicians are more receptive to using contingency management to support behavioural changes other than abstinence.
Our study examines the effects of a high-dose stimulant lisdexamfetamine and contingency management, alone and in combination, on MA use compared with treatment as usual (which includes clinical management and behavioural therapies) in individuals with moderate to severe MA use disorder. For contingency management, we will incentivize attendance at clinic visits. We will recruit a total of 440 participants in British Columbia, Alberta, Ontario, Quebec, and New Brunswick. Our primary outcome will be self-reported MA use; we will also evaluate other key outcomes such as quality of life, craving, mental health, and adherence to treatment.
The Lead Principal Investigator for ASCME is Didier Jutras-Aswad. There is also one Site Principal Investigator at each Node with expertise in substance use research and addiction medicine responsible for the trial sites within their Node (Paxton Bach, Monty Ghosh, Bernard Le Foll, Sara Davisdson). The Trial Steering Committee consists of the Lead Investigating Principal Investigator, two individuals with Indigenous background and/or competencies, two people with lived and living experience, one CRISM nominated Principal Investigator, two independent members with relevant expertise in addiction and clinical trials, and the National Project Coordinator.
This trial will help improve our understanding of substitution therapy and contingency management in MA use disorder, which will in turn improve care and support for individuals who use MA.
Objectives
To measure the effectiveness of lisdexamfetamine and engagement-focused contingency management, both alone and in combination, in addition to treatment as usual on outcomes such as reduced methamphetamine use, retention in treatment, participant satisfaction, and quality of life.
Partners
- Centre d’intégration et d’analyse des données médicales (CITADEL)
- Centre hospitalier universitaire de l’Université de Montréal (CHUM)
- Centre for Addiction and Mental Health (CAMH)
- University of Calgary
- University of British Columbia
- BC Centre on Substance Use
Funders
- Canadian Institutes of Health Research
Investigator
Didier Jutras-Aswad is Principal Scientist at CHUM and clinical researcher in addiction psychiatry, who has conducted RCTs on novel pharmacotherapies and models of care for substance use disorders (including stimulant) and mental health comorbidities. He led the OPTIMA trial (the first Canadian Research Initiative in Substance Matters multisite trial), and is currently the lead Principal Investigator on the parent ASCME trial.
Related Content
- "ASCME Trial" (River Stone Recovery Centre)
- "Finding a new intervention for methamphetamine use disorder while tackling social issues and stigma" (CIHR)