ASCME Clinical Trial

The primary objective of this trial is to determine if adding high-dose lisdexamfetamine (LDX-01) (a psychostimulant) and engagement-focused CM, alone and in combination, to treatment as usual (TAU) reduces MA use in individuals with moderate to severe MA use disorder within a 12-week treatment period.

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About the study

Principal investigator

Dr. Paxton Bach

MD, MSc, FRCPC

Area(s) of medical focus

Substance Use & Addictions

Condition(s)

Substance use

Period of enrollment

2024-07-18 - 2026-06-30

Participating sites

St. Paul's Hospital

Purpose of trial

In Canada, the use of methamphetamine has increased drastically over the past decade, which has led to increased overdose, hospitalizations, and deaths. Unfortunately, there are no current medications approved for the treatment of this disorder. The ASCME trial is being conducted to determine if high doses of the prescribed psychostimulant lisdexamfetamine (Vyvanse) and contingency management focused on client engagement can reduce days of methamphetamine use in people with methamphetamine use disorder over a 12-week treatment period. The results of this trial will help inform clinicians, frontline workers, and policy makers about approaches to the treatment of methamphetamine use disorder.

Eligibility

  1. The participant is between 18 and 55 years of age, inclusively.
  2. The participant has active MA use at screening measured via self-reported MA use ≥14 days in the past 28 days.
  3. The participant is interested in reducing/stopping MA use.
  4. The participant is willing to be randomized to one of the 4 study arms and followed for the 
    duration of the trial.
  5. The participant is able to provide informed consent.
  6. The participant is willing to comply with study procedures.
  7. The participant is able to communicate in English. 

Associated resources

Contact information

Co-Investigators

Dr. Sukhpreet Klaire

Additional Information

Study Phase

Phase 2

Relevant Links

Clinical Trials