Feasibility of Long-term, High-dose Stimulant for Methamphetamine Use Disorder

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

NCT Number	NCT06788587
Lead Sponsor	Centre hospitalier de l'Université de Montréal (CHUM) Collaborators: Ministere de la Sante et des Services Sociaux, Health Canada
Conditions	Methamphetamine Abuse, Methamphetamine-dependence, Addiction, Substance Abuse, Methamphetamine Use Disorder
Enrollment	80 participants
Start Date	2025-07-18
Primary Completion	2027-08 (estimated)
Study Completion	2027-12 (estimated)
Updated on ClinicalTrials.gov	2026-02-23