NCT06788587 Feasibility of Long-term, High-dose Stimulant for Methamphetamine Use Disorder
| NCT ID | NCT06788587 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Centre hospitalier de l'Université de Montréal (CHUM) |
| Condition | Methamphetamine Abuse |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2025-07-18 |
| Primary Completion | 2027-08 |
Trial Parameters
Eligibility Fast-Check
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Brief 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
Eligibility Criteria
Inclusion Criteria: 1. Between 18 and 55 years of age at enrollment in the parent ASCME trial; 2. Diagnosed with a moderate to severe MUD as defined by the DSM-5 criteria; 3. Enrolled in the parent ASCME trial and completed the study up to and including the end of study visit at Week 20, Day 1; 4. Interested in avoiding relapse, decreasing methamphetamine use, or abstaining from methamphetamine use; 5. Presence of ongoing substance use, craving, or significant risk of relapse that according to the study physician, warrants extended treatment for MUD; 6. If female: * Be of non-childbearing potential, defined as (i) postmenopausal (12 months of spontaneous amenorrhea and ≥ 45 years of age); or (ii) documented surgically sterilized (i.e., tubal ligation, hysterectomy, or bilateral oophorectomy); or * Be of childbearing potential, have a negative pregnancy test at screening, and agree to use an acceptable method of birth control throughout the study; 7. Willing to be randomized to one of 2