Actively Recruiting
Feasibility of Long-term, High-dose Stimulant for Methamphetamine Use Disorder
Led by Centre hospitalier de l'Université de Montréal (CHUM) · Updated on 2026-02-23
80
Participants Needed
1
Research Sites
123 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 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
CONDITIONS
Official 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 as defined by DSM-5 criteria
- Completed the parent ASCME trial up to and including the end of study visit at Week 20, Day 1
- Interested in avoiding relapse, decreasing methamphetamine use, or abstaining from methamphetamine use
- Presence of ongoing substance use, craving, or significant risk of relapse warranting extended treatment for MUD
- If female, be either of non-childbearing potential (postmenopausal or surgically sterilized) or of childbearing potential with a negative pregnancy test at screening and agreement to use birth control throughout the study
- Willing to be randomized to one of two study arms and followed for the trial duration
- Able to start the study intervention within 28 days after completing the ASCME main 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, moderate hypertension, confirmed current hyperthyroidism, or hypersensitivity to sympathomimetic amines or glaucoma
- Any disabling, severe, or unstable medical condition that precludes safe participation or informed consent
- Severe or unstable co-morbid substance use disorder preventing safe participation
- Opioid use disorder patients on opioid agonist treatment for less than 12 weeks or not stabilized for at least 4 weeks
- Current or history of serious psychiatric disorder (e.g., bipolar disorder, psychosis, schizophrenia) prohibiting safe participation
- History of serious allergic reaction to LDX-01 or amphetamines
- Pregnant, nursing, or planning pregnancy during the study
- Planned extended absence during the study (e.g., legal issues, surgery, incarceration, inpatient program)
- Use of investigational drugs for stimulant use disorder within 30 days before screening, except parent trial medication
- Use of prescribed amphetamine-type or stimulant use disorder medications within 4 weeks before screening
- Current or expected need for medications interacting with LDX-01 (e.g., MAOIs) within 14 days
- Prolonged QTc interval on ECG at screening (≥460 ms females, ≥450 ms males)
- Serious adverse events related to the study product in parent trial
- Compliance issues with study product or procedures during the parent trial
AI-Screening
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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
CONTACT
A
Amina Sow, Ph.D
CONTACT
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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