Your session is about to expire
← Back to Search
Stimulant
Lisdexamfetamine + Contingency Management for Methamphetamine Addiction
Phase 2
Recruiting
Led By Didier Jutras-Aswad
Research Sponsored by Centre hospitalier de l'Université de Montréal (CHUM)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up administered at baseline, week 8, 14 and 20
Summary
This trial aims to see if high dose stimulant plus contingency management can help adults reduce their days of using methamphetamine better than usual treatment.
Who is the study for?
Adults aged 18-55 with moderate to severe methamphetamine (MA) addiction, actively using MA, and interested in reducing or stopping use. Women must be non-pregnant, non-nursing, and if of childbearing potential, agree to use birth control. Excludes those with serious heart disease, hypertension, hyperthyroidism; severe psychiatric disorders; recent other substance abuse treatments; or on certain medications.
What is being tested?
The trial tests whether high dose lisdexamfetamine (LDX), a stimulant medication combined with Contingency Management (rewards for meeting treatment goals), is more effective than placebo at reducing MA use when added to usual treatment. Participants are randomly assigned to one of four groups: usual treatment plus placebo, with or without Contingency Management; or usual treatment plus LDX-01, with or without Contingency Management.
What are the potential side effects?
Lisdexamfetamine may cause side effects such as rapid heartbeat, anxiety, insomnia, loss of appetite and weight loss. It can also increase blood pressure and has the potential for misuse.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ administered at baseline, week 8, 14 and 20
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~administered at baseline, week 8, 14 and 20
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Total number of days of methamphetamine use during maintenance phase
Secondary study objectives
Changes in Quality of Life
Indigenous wellness perspective
Medication Adherence
+4 moreTrial Design
4Treatment groups
Active Control
Placebo Group
Group I: Treatment as Usual plus lisdexamfetamine (LDX-01)Active Control1 Intervention
Participants will receive treatment as usual at the clinic as well as once daily over-encapsulated lisdexamfetamine (LDX-01) orally for 15 weeks.
Group II: Treatment as Usual plus lisdexamfetamine (LDX-01) plus Contingency ManagementActive Control1 Intervention
Participants will receive treatment as usual at the clinic, once daily over-encapsulated lisdexamfetamine (LDX-01) orally for 15 weeks, as well as engagement-focused contingency management.
Group III: Treatment as Usual plus PlaceboPlacebo Group1 Intervention
Participants will receive treatment as usual at the clinic as well as once daily lisdexamfetamine matched Placebo orally for 15 weeks.
Group IV: Treatment as Usual plus Placebo plus Contingency ManagementPlacebo Group1 Intervention
Participants will receive treatment as usual at the clinic, once daily lisdexamfetamine matched placebo medication orally for 15 weeks, as well as engagement-focused contingency management.
Find a Location
Who is running the clinical trial?
Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor
377 Previous Clinical Trials
130,940 Total Patients Enrolled
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,383 Previous Clinical Trials
26,515,159 Total Patients Enrolled
Didier Jutras-AswadPrincipal InvestigatorUniversity of Montreal Hospital Research Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You want to reduce or stop using medication for migraines.I am following the required birth control guidelines due to my childbearing potential.I do not have severe or unstable heart, thyroid, eye conditions, or allergies that would make it unsafe for me to participate.I am between 18 and 55 years old.I want to reduce or stop using methamphetamine.I have used methamphetamine on 14 or more days in the last month, confirmed by a urine test.I can communicate in English or French.You have been diagnosed with a serious problem with using methamphetamine, as determined by the DSM-5 guidelines.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment as Usual plus Placebo
- Group 2: Treatment as Usual plus Placebo plus Contingency Management
- Group 3: Treatment as Usual plus lisdexamfetamine (LDX-01)
- Group 4: Treatment as Usual plus lisdexamfetamine (LDX-01) plus Contingency Management
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Share this study with friends
Copy Link
Messenger