Feasibility of Long-term, High-dose Stimulant for Methamphetamine Use Disorder
Status:
RECRUITING
Trial end date:
2027-12-01
Target enrollment:
Participant gender:
Summary
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
Phase:
PHASE2
Details
Lead Sponsor:
Centre hospitalier de l'Universit de Montral (CHUM)
Collaborators:
Health Canada Ministere de la Sante et des Services Sociaux