Actively Recruiting
Exploring Feasibility and Acceptability of Prolonged High-Dose Lisdexamfetamine Treatment in Methamphetamine Use Disorder: An Extension of a Randomized, Placebo-Controlled Trial
Led by Centre hospitalier de l'Université de Montréal (CHUM) · Updated on 2026-02-23
80
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
Sponsors
C
Centre hospitalier de l'Université de Montréal (CHUM)
Lead Sponsor
M
Ministere de la Sante et des Services Sociaux
Collaborating Sponsor
AI-Summary
What this Trial Is About
Methamphetamine use disorder (MUD) is a growing public health concern. Researchers are evaluating the long-term use of high-dose stimulant agonist therapy with Lisdexamfetamine (LDX-01) alongside standard treatment in people with moderate to severe MUD. This phase 2 trial aims to assess the feasibility of this approach, focusing on treatment retention, adherence, and satisfaction compared to a placebo group. Participants will be randomly assigned to one of two groups: standard treatment plus high-dose LDX-01 or standard treatment plus a matched placebo. The medication is given once daily for 25 weeks in three phases: induction with increasing doses during the first week, maintenance with a target dose from weeks 2 to 21, and tapering doses from weeks 22 to 25. Treatment is provided at a clinical site with weekly visits. During the 30-week participation, participants will attend weekly clinic visits for medication and assessments. Urine samples will be collected every two weeks from weeks 1 to 25, and again at weeks 26 and 30. Questionnaires will also be completed during visits. The main outcomes measured include retention in treatment and study, treatment satisfaction, and adherence throughout the study period.
CONDITIONS
Brief Title
Feasibility of Long-term, High-dose Stimulant for Methamphetamine Use Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Between 18 and 55 years of age at enrollment in the parent ASCME trial
- Diagnosed with moderate to severe methamphetamine use disorder by DSM-5 criteria
- Completed the parent ASCME trial up to Week 20, Day 1
- Interested in avoiding relapse, reducing, or abstaining from methamphetamine use
- Ongoing substance use, craving, or risk of relapse warranting extended treatment
- If female, either non-childbearing or using acceptable birth control with negative pregnancy test
- Willing to be randomized and followed for the trial duration
- Able to start study intervention within 28 days after completing the parent trial
- Able to provide informed consent
- Willing to comply with study procedures
- Able to communicate in English or French
You will not qualify if you...
- Symptomatic or advanced cardiovascular disease or moderate hypertension
- Confirmed current hyperthyroidism
- Known allergy or sensitivity to sympathomimetic amines or glaucoma
- Severe or unstable co-morbid substance use disorder
- Opioid Use Disorder patients on opioid agonist treatment less than 12 weeks or not stabilized for 4 weeks
- Current or history of serious psychiatric disorders like bipolar disorder or schizophrenia
- History of serious adverse events or allergic reactions to LDX-01 or amphetamines
- Pregnant, nursing, or planning pregnancy during the study
- Planned extended absence during study that may prevent completion
- Use of investigational drugs for stimulant use disorder in past 30 days (excluding parent trial medication)
- Use of prescribed stimulant medications or treatments for stimulant use disorder in past 4 weeks
- Need for medications that interact with LDX-01 such as MAO inhibitors
- Prolonged QTc interval on ECG at screening
- Serious adverse events related to study product in parent trial
- Compliance issues during parent trial that preclude safe participation in extension study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 25 weeks
Participants receive once daily medication or placebo along with treatment as usual (TAU) at the clinic for methamphetamine use disorder. Medication dosage is adjusted in phases over the course of the treatment.
Weekly visits for 25 weeks
Duration - 5 weeks
Participants continue to attend clinic visits for monitoring and provide urine samples and questionnaires after treatment ends to assess retention and treatment satisfaction.
Visits during weeks 26 and 30 with urine sample collection
Trial Site Locations
Total: 1 location
1
Centre hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, Canada, H2X 0A9
Actively Recruiting
Research Team
D
Devon Blanchette
A
Amina Sow, Ph.D
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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