Actively Recruiting

Phase 2
Age: 18Years - 55Years
All Genders
Healthy Volunteers
NCT05854667

Clinical Trial of High Dose Lisdexamfetamine and Contingency Management in MA Users

Led by Centre hospitalier de l'Université de Montréal (CHUM) · Updated on 2026-02-05

440

Participants Needed

4

Research Sites

225 weeks

Total Duration

On this page

Sponsors

C

Centre hospitalier de l'Université de Montréal (CHUM)

Lead Sponsor

C

Canadian Institutes of Health Research (CIHR)

Collaborating Sponsor

AI-Summary

What this Trial Is About

The goal of this clinical trial is to learn if administering a high dose stimulant with Contingency Management reduces days of use in adults who use methamphetamine better than the usual treatment provided by the clinic. The main questions the trial aims to answer are: Is a high dose stimulant better than a placebo and usual treatment at helping reduce the number of days they use methamphetamine? Is a high dose stimulant with contingency management better than placebo and usual treatment at helping people reduce the number of days they use methamphetamine? Participants will be placed randomly into one of four groups: 1. Usual treatment and placebo 2. Usual treatment, placebo and contingency management 3. Usual treatment and high dose stimulant 4. Usual treatment, high dose stimulant and contingency management Participation includes the following: 1. Participants will receive medication or placebo weekly for 15 weeks. 2. Participants will attend the clinic for weekly treatment 3. Participants will attend the clinic once every 2 weeks for study visits. Each visit will take about an hour to complete. At these visits, participants will be asked to provide a urine sample and complete questionnaires.

CONDITIONS

Official Title

Clinical Trial of High Dose Lisdexamfetamine and Contingency Management in MA Users

Who Can Participate

Age: 18Years - 55Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Between 18 and 55 years of age
  • Diagnosed with moderate to severe methamphetamine use disorder according to DSM-5 criteria
  • Active methamphetamine use with self-reported use at least 14 days in the past 28 days verified by urine test
  • Interested in reducing or stopping methamphetamine use
  • For females: either not able to have children (postmenopausal or surgically sterilized) or of childbearing potential with a negative pregnancy test and willing to use birth control during the study
  • Willing to be randomly assigned to one of the four study groups and complete the study
  • Able to give informed consent
  • Able to follow study procedures
  • Able to communicate in English or French
Not Eligible

You will not qualify if you...

  • Having symptomatic or advanced cardiovascular disease, moderate hypertension, or current hyperthyroidism
  • Known allergy or severe reaction to sympathomimetic amines or glaucoma
  • Any severe or unstable substance use disorder that would prevent safe participation
  • Opioid use disorder patients on opioid agonist therapy for less than 12 weeks or not yet stable
  • Current or history of serious psychiatric disorders like bipolar disorder or schizophrenia
  • Previous severe allergic reaction to lisdexamfetamine or similar drugs
  • Pregnant, nursing, or planning pregnancy during the study
  • Planned long absence during the study that may prevent completion
  • Use of investigational drugs for stimulant use disorder within 30 days before screening
  • Receiving contingency management for stimulant use disorder within 4 weeks before screening
  • Use of prescribed amphetamine-type or stimulant disorder medications within 4 weeks before screening
  • Need for medications that interact with lisdexamfetamine currently or within the past 14 days

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 4 locations

1

Rapid Access Addiction Medicine Clinic, St. Paul's Hospital

Vancouver, British Columbia, Canada

Actively Recruiting

2

River Stone Recovery Centre

Fredericton, New Brunswick, Canada, E3B 1E3

Suspended

3

Center for Addiction and Mental Health

Toronto, Ontario, Canada, M6J 1HN

Actively Recruiting

4

University of Montreal Hospital Research Center

Montreal, Quebec, Canada, H2X 0A9

Actively Recruiting

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Research Team

D

Devon Blanchette

CONTACT

A

Amina Sow

CONTACT

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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