NCT06788587

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

Exploring Feasibility and Acceptability of Prolonged Administration of High-Dose Stimulants in People With Methamphetamine Use Disorder: An Extension of a Randomized, Placebo-Controlled Trial

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM) · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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

Detailed description

This trial is a single-centre, randomized double-blind (LDX-01), dose-ascending, placebo-controlled trial. This study is an extension to a parent trial, Addition of high-dose stimulant and engagement-focused contingency management, alone and in combination, to treatment as usual for the management of methamphetamine use disorder (ASCME): a pan-Canadian multi-centre, randomized, controlled trial (NCT05854667). Participants will be enrolled in one of the 2 treatment arms: Arm 1 : TAU plus high-dose LDX-01 Arm 2 : TAU plus placebo The trial will enroll 62-80 participants who have completed the parent trial in the Quebec site. The participants will be enrolled in the trial for 30 weeks. Participation includes the following: 1. Participants will receive medication or placebo weekly for 25 weeks 2. Participants will attend the clinic for weekly treatment 3. Participants will attend the clinic once every week for study visits. At these visits, participants will be asked to provide a urine sample (Weeks 1-25: every two weeks, week 26 and week 30) and/or complete questionnaires

Conditions

• Methamphetamine Abuse
• Methamphetamine-dependence
• Addiction
• Substance Abuse
• Methamphetamine Use Disorder

Interventions

Type	Name	Description
DRUG	LDX-01 plus TAU	Participants receive once daily LDX-01 for 25 weeks, as well as TAU at a clinical site. Medication is provided in 3 phases: Week 1 (Induction Phase): 100 mg (Days 1 and 2), 150 mg (Days 3 and 4), 200 mg (Days 5, 6 and 7); Weeks 2-21 (Maintenance Phase): 250 mg (or the maximum tolerated for each individual) ; Weeks 22-25 (Taper Phase): 200 mg (Week 22), 150 mg (Week 23), 100 mg (Week 24) and 50 mg (Week 25).
DRUG	Placebo plus TAU	Participants receive once daily LDX-01-matched placebo for 25 weeks, as well as TAU at a clinical site. Medication is provided in 3 phases: Week 1 (Induction Phase): 100 mg (Days 1 and 2), 150 mg (Days 3 and 4), 200 mg (Days 5, 6 and 7); Weeks 2-21 (Maintenance Phase): 250 mg (or the maximum tolerated for each individual) ; Weeks 22-25 (Taper Phase): 200 mg (Week 22), 150 mg (Week 23), 100 mg (Week 24) and 50 mg (Week 25).

Timeline

• Start date: 2025-07-18
• Primary completion: 2027-08-01
• Completion: 2027-12-01
• First posted: 2025-01-23
• Last updated: 2026-02-23

Locations

1 site across 1 country: Canada