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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

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 weeks
Treatment ~ Varies
Follow Up ~administered at baseline, week 8, 14 and 20
This trial's timeline: 3 weeks for screening, Varies for treatment, and administered at baseline, week 8, 14 and 20 for reporting.

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 more

Trial 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
370 Previous Clinical Trials
129,375 Total Patients Enrolled
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,354 Previous Clinical Trials
26,460,079 Total Patients Enrolled
Didier Jutras-AswadPrincipal InvestigatorUniversity of Montreal Hospital Research Center

Media Library

Lisdexamfetamine (Stimulant) Clinical Trial Eligibility Overview. Trial Name: NCT05854667 — Phase 2
Methamphetamine Abuse Research Study Groups: Treatment as Usual plus Placebo, Treatment as Usual plus Placebo plus Contingency Management, Treatment as Usual plus lisdexamfetamine (LDX-01), Treatment as Usual plus lisdexamfetamine (LDX-01) plus Contingency Management
Methamphetamine Abuse Clinical Trial 2023: Lisdexamfetamine Highlights & Side Effects. Trial Name: NCT05854667 — Phase 2
Lisdexamfetamine (Stimulant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05854667 — Phase 2
~293 spots leftby Nov 2025