ASCME
Addition of high dose stimulant and engagement-focused contingency management, alone and in combination, to treatment as usual for the management of methamphetamine use disorder (ASCME): a pan-Canadian multi-centre, randomized, controlled trial
About
Didier Jutras-Aswad, MD, MS, FRCPC
Adults between ages 18 and 55 years, diagnosed with moderate to severe Methamphetamine (MA) use disorders.
Multi-centre, 4-arm, randomized, double blind (LDX-01 component), open label (CM component), dose-ascending, placebo-controlled trial.
Co-Investigators & Participating Sites
Objectives
Primary Objective :
- Determine if adding high-dose lisdexamfetamine (LDX) and engagement focused CM, alone and in combination, to TAU, reduces days of MA use in individuals with moderate to severe MA use disorder within a 12-week maintenance treatment period.
Secondary Objective :
- Measure the effect of the interventions between study arms on clinically relevant outcomes including quality of life, retention, other indicators of MA and other substance use, mental health, treatment satisfaction and engagement, cravings, safety, and cost-effectiveness.
- Evaluate employment, interaction with the criminal justice system, risk behaviours, self-reported use of other substances and related problems, and other health-related outcomes, and explore predictors of treatment success.
Context
Globally, methamphetamine (MA) and other stimulant drugs are the second most widely used illicit substance after cannabis, which is now legal in some jurisdictions (United-Nations, 2018). While the overall prevalence of MA use in Canada is low—3.7% of Canadians aged 15 and older report using MA at least once (United-Nations, 2019)— MA use is becoming an increasing public health concern.
The increase in MA use in Canada coincides with its growing presence in the illicit drug market. MA possession rates increased by 590% from 2010-2017, and the amount of MA seized by law enforcement increased by 200% from 2014-2016.(Canadian-Centre-on-Substance-Abuse, 2018) MA has high abuse potential with symptoms of substance use disorder that can manifest within one week of initial exposure.(American-Psychiatric-Association, 2013) Withdrawal symptoms include fatigue, depression, suicidality, anxiety, and intense cravings.(Canadian-Centre-on-Substance-Abuse, 2018) Long-term use is associated with psychotic symptoms (e.g. paranoia, hallucinations), violent behaviour, self-mutilation, depressive symptoms, and suicidal thoughts, as well as increased risk of HIV and Hepatitis C transmission (mainly due to high-risk behaviours) and cardiovascular events.(Canadian-Centre-on-Substance-Abuse, 2018; Siefried et al., 2020; Vearrier et al., 2012)
There are no pharmaceutical treatments for MA use disorder currently approved by Health Canada or other regulatory agencies. Standard clinical management is commonly used, incorporating cognitive behavioural and motivational therapy components, but there are few evidence-based interventions that are widely available for MA use disorder treatment. As MA use increases in Canada, there is an urgent need for a comprehensive therapeutic approach to MA use disorder, which includes both pharmacological and psychosocial treatment options. (Hill, 2015)
Ancillary Study
- Advancing understandings of randomized clinical trials in substance use research (AURA): Qualitative Evaluation of Methamphetamine Use Disorder Research Participation.
- PIs: Lindsey Richardson (PhD), Kate Jaffe | Co-I: Dr. Didier Jutras-Aswad (MD, MS, FRCPC)
- Financing: Substance Use and Dependence Program (SUAP)
- Exploring Feasibility and Acceptability of Prolonged Administration of High-Dose Stimulants in People with Methamphetamine Use Disorder: An Extension of a Randomized, Placebo-Controlled Trial (ASCME-EXT)
- PI: Dr. Didier Jutras-Aswad (MD, MS, FRCPC)| Co-Is: Dr. Paxton Bach (MD, PHD), Dr. Louis-Christophe (MS, MSc), Bernard Le Foll (MD), Davidson, Sara (MD), Poulin, Ginette (MD)
- Financing: Ministère de la Santé et des Services sociaux (MSSS) & Health Canada – Substance Use and Dependence Program (SUAP)
Publications
- Bach, P., Le Foll, B., Davidson, S., de Kiewit, A., Bakouni, H., Poulin, G., Ghosh, M., & Jutras-Aswad, D. (2025). A protocol for high-dose lisdexamfetamine and contingency management, alone or in combination, for the treatment of methamphetamine use disorder: The ASCME study. Contemporary Clinical Trials, 153, Article 107502.
