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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
Awards & highlights
Study 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.Check my eligibility
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.See study design
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Total number of days of methamphetamine use during maintenance phase
Secondary outcome measures
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.
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Who is running the clinical trial?
Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor
369 Previous Clinical Trials
129,397 Total Patients Enrolled
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,348 Previous Clinical Trials
26,455,145 Total Patients Enrolled
Didier Jutras-AswadPrincipal InvestigatorUniversity of Montreal Hospital Research Center
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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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment still possible for this clinical experiment?
"The clinical trial posted on June 1st, 2023 is not presently accepting participants according to the information available on clinicaltrials.gov. However, there are an additional 433 medical trials which remain open for enrollment at this time."
Answered by AI
Can people above the age of twenty-five partake in this research?
"This research is seeking participants aged 18 or older, but younger than 55."
Answered by AI
How may I register to participate in this experiment?
"In order to meet the enrollment requirements of this trial, candidates must have a history of methamphetamine abuse and lie between 18-55 years old. The study is hoping to recruit approximately 440 participants in total."
Answered by AI
What risks do individuals face when prescribed a combination of Treatment as Usual and lisdexamfetamine (LDX-01)?
"With the available Phase 2 data in mind, our team at Power assigned a score of 2 to Treatment as Usual plus lisdexamfetamine (LDX-01) for safety."
Answered by AI
Are there any Canadian medical centers executing this clinical research?
"Patients at the River Stone Recovery Centre in Fredericton, New Brunswick; Center for Addiction and Mental health in Toronto, Ontario; and University of Montreal Hospital Research Center in Montréal, Quebec can enrol in this trial. Additionally, there are 4 other sites enrolling participants."
Answered by AI
Who else is applying?
What site did they apply to?
Center for Addiction and Mental Health
University of Montreal Hospital Research Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Why did patients apply to this trial?
Barriers to accessing treatment, no family doctor, no resources or support, interest in rehabilitation.
PatientReceived 2+ prior treatments
I’m I have been addicted to it for a year. I am tired of it. I tried to do detox It hasn’t worked for a while and I did sublucade that works a bit However, the dosages are not high enough. I have had ADHD meds, but they would only give me 60 mg so it’s not working.
PatientReceived 2+ prior treatments
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