A Canadian Clinical Trial Testing High Dose Lisdexamfetamine and Contingency Management to Help Adults Reduce Methamphetamine Use
Led by Centre hospitalier de l'Université de Montréal (CHUM) · Updated on 2026-02-05
440
Participants Needed
4
Research Sites
17 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating whether giving a high dose stimulant combined with Contingency Management helps adults who use methamphetamine reduce their days of use better than usual treatment. This multi-center, randomized, double-blind, placebo-controlled trial includes participants diagnosed with moderate to severe methamphetamine use disorder and aims to answer if the stimulant or the stimulant plus Contingency Management is more effective than placebo and usual care.
Participants are randomly assigned to one of four groups treatment as usual plus placebo, treatment as usual plus placebo with Contingency Management, treatment as usual plus high dose lisdexamfetamine, or treatment as usual plus high dose lisdexamfetamine with Contingency Management. The stimulant is taken orally once daily for 15 weeks with dosing starting lower and increasing in the first week, followed by a maintenance phase and then tapering. Contingency Management is provided for 12 weeks alongside the other treatments.
During the 20-week trial, participants visit the clinic weekly for treatment and biweekly for study assessments lasting about an hour. At these visits, urine samples are collected and questionnaires completed to monitor methamphetamine use and other outcomes. Researchers will track medication adherence, safety events, quality of life changes, and treatment satisfaction. The main measure is the total number of days using methamphetamine during the 12-week maintenance phase.
CONDITIONS
Brief Title
Clinical Trial of High Dose Lisdexamfetamine and Contingency Management in MA Users
Research Team
D
Devon Blanchette
A
Amina Sow
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Centre hospitalier de l'Université de Montréal (CHUM)
Lead Sponsor
Canadian Institutes of Health Research (CIHR)
Collaborating Sponsor
Who Can Participate
Age: 18Years - 55Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
Between 18 and 55 years of age
Diagnosed with moderate to severe methamphetamine use disorder according to DSM-5
Active methamphetamine use with at least 14 days of use in the past 28 days confirmed by urine test
Interested in reducing or stopping methamphetamine use
Females must be either non-childbearing or use birth control throughout the study
Willing to be randomized and followed for the trial duration
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
Current hyperthyroidism or known allergy to sympathomimetic amines
Severe or unstable co-morbid substance use disorder
Opioid Use Disorder on unstable or recent opioid agonist therapy
Serious psychiatric disorders like bipolar disorder or schizophrenia
History of severe adverse reaction to lisdexamfetamine or amphetamines
Pregnant, nursing, or planning pregnancy during study
Planned extended absence during study period
Use of investigational stimulant use disorder drugs in last 30 days
Receiving contingency management for stimulant use disorder in last 4 weeks
Use of prescribed amphetamine-type or other stimulant disorder medications in last 4 weeks
Need for medications interacting with lisdexamfetamine currently or within past 14 days that prevent safe participation
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 15 weeks
Participants receive once daily lisdexamfetamine or placebo for 15 weeks along with treatment as usual at the clinical site. Some participants will also receive engagement-focused contingency management during weeks 2 to 13.
Weekly visits for up to 15 weeks
Follow-up
Duration - 5 weeks
Participants are monitored for safety and other outcomes after treatment ends.
1 visit at Week 20
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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Published Research Related To This Trial
A protocol for high-dose lisdexamfetamine and contingency management, alone or in combination, for the treatment of methamphetamine use disorder: The ASCME study.