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

StatusRecruiting
PhasePhase 2
Started2023-12-05
View on ClinicalTrials.gov ↗

Amendment history

2026-02-03
minor
Study Status, Contacts/Locations v11
Study sitescontacts updated at 1 of 4 sites
2025-12-17
minor
Study Status v10
Primary completion date2025-11→2027-12
Completion date2025-11→2028-04
2025-07-02
minor
Study Status, Contacts/Locations v9
Study sitescontacts updated at 1 of 4 sites
2025-04-04
minor
Study Status, Contacts/Locations v8
Study sitescontacts updated at 1 of 4 sites
2025-02-14
minor
Study Identification, Study Status, Contacts/Locations v7
Study sitesdetails revised at 1 of 4 sites
Show 6 earlier versions
2024-11-07
minor
Study Status, Contacts/Locations v6
Study sitesdetails revised at 2 of 4 sites
2024-06-19
minor
Study Status, Contacts/Locations v5
Study sitesdetails revised at 1 of 4 sites
2024-04-10
minor
Study Status, Contacts/Locations v4
Study sitesdetails revised at 1 of 4 sites
2024-02-15
minor
Study Status, Contacts/Locations v3
Study sitescontacts updated at 3 of 4 sites
2023-12-07
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2023-12→confirmed 2023-12-05
Study sitesdetails revised at 4 of 4 sites
2023-10-18
minor
Study Status v1
Start date2023-06→2023-12
2023-05-02
minor
Original filing
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.
Trial Details
NCT Number NCT05854667
Lead Sponsor Centre hospitalier de l'Université de Montréal (CHUM)
Collaborators: Canadian Institutes of Health Research (CIHR)
Conditions Methamphetamine Abuse, Methamphetamine-dependence, Addiction, Substance, Addiction
Enrollment 440 participants
Start Date 2023-12-05
Primary Completion 2027-12 (estimated)
Study Completion 2028-04 (estimated)
Updated on ClinicalTrials.gov 2026-02-05