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

StatusRecruiting
PhasePhase 2
Started2025-07-18
View on ClinicalTrials.gov ↗

Amendment history

2026-02-19
minor
Study Status, Outcome Measures, Contacts/Locations v4
Study sitescontacts updated at 1 of 1 site
2025-09-11
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-07→confirmed 2025-07-18
Study sitesdetails revised at 1 of 1 site
2025-07-02
minor
Study Status v2
Start date2025-05→2025-07
2025-04-04
minor
Study Status, Contacts/Locations v1
Primary completion date2027-06→2027-08
Start date2025-03→2025-05
Study sites2→1
2025-01-16
minor
Original filing
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
Trial Details
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