Methamphetamine use disorder (MUD) is becoming an increasing public health concern in Canada. While the evidence on the efficacy and safety of prescription psychostimulants for the treatment of MUD is promising, the knowledge on the maintenance therapy using stimulant agonist therapy is scarce and needs further investigation, especially in terms of long-term retention in treatment.
The goal of this clinical trial is to evaluate the feasibility of a long-term (25 weeks) administration of high-dose stimulant agonist therapy, using Lisdexamfetamine (LDX-01) on top of treatment-as-usual (TAU), in a population of people with moderate to severe MUD, as measured by study retention, treatment retention, treatment adherence and satisfaction compared against a placebo group.
Participants will be placed randomly into one of two groups:
1. TAU and high-dose LDX-01 2. TAU and placebo
Between 18 and 55 years of age at enrollment in the parent ASCME trial;
Diagnosed with a moderate to severe MUD as defined by the DSM-5 criteria;
Enrolled in the parent ASCME trial and completed the study up to and including the end of study visit at Week 20, Day 1;
Interested in avoiding relapse, decreasing methamphetamine use, or abstaining from methamphetamine use;
Symptomatic or advanced cardiovascular disease (e.g., advanced arteriosclerosis), moderate hypertension; confirmed current hyperthyroidism; known hypersensitivity or idiosyncrasy to the sympathomimetic amines or glaucoma or any disabling, severe, or unstable medical condition (including electrolyte disturbances) that, in the opinion of the study physician, precludes safe participation or the ability to provide fully informed consent;
Any severe or unstable co-morbid substance use disorder that, in the opinion of the study physician, precludes safe participation in the study;
Participants with Opioid Use Disorder (OUD) who have been on Opioid Agonist Treatment (OAT) for <12 weeks, and not yet at stabilization dose, or at stabilization dose <4 weeks;
Current or a history of any serious psychiatric disorder (e.g., bipolar disorder, pre-existing psychosis, schizophrenia) that, in the opinion of the study physician, precludes safe participation in the study;
Centre hospitalier de l'Université de Montréal (CHUM)
Lead sponsor
Ministere de la Sante et des Services Sociaux
Collaborator
Health Canada
Collaborator