440
Participants
Start Date
December 5, 2023
Primary Completion Date
November 30, 2025
Study Completion Date
November 30, 2025
Treatment as Usual plus Placebo
Participants receive once daily Lisdexamfetamine matched placebo for 15 weeks, as well as treatment as usual at clinical site.
Treatment as Usual plus Placebo plus Contingency Management
Participants receive once daily Lisdexamfetamine matched placebo for 15 weeks, as well as treatment as usual at clinical site, and engagement-focused contingency management for 12 weeks, week 2-13.
Treatment as Usual plus lisdexamfetamine (LDX-01)
"Participants receive once daily Lisdexamfetamine for 15 weeks, as well as treatment as usual at clinical site. Medication is provided in 3 phases:~Week 1 (Induction Phase): 100 mg (Day 1 and 2), 150 mg (Day 3 and 4), 200 mg (Day 5, 6 and 7) Weeks 2-13 (Maintenance Phase): 250 mg per day (or the maximum tolerated for each individual) and then will continue on the same daily dose Weeks 14-15 (Taper Phase): 150 mg (Week 14) and 50 mg (Week 15)."
Treatment as Usual plus lisdexamfetamine (LDX-01) plus Contingency Management
"Participants receive once daily Lisdexamfetamine for 15 weeks, as well as treatment as usual at clinical site. Medication is provided in 3 phases:~Week 1 (Induction Phase): 100 mg (Day 1 and 2), 150 mg (Day 3 and 4), 200 mg (Day 5, 6 and 7) Weeks 2-13 (Maintenance Phase): 250 mg per day (or the maximum tolerated for each individual) and then will continue on the same daily dose Weeks 14-15 (Taper Phase): 150 mg (Week 14) and 50 mg (Week 15). Engagement-focused contingency management will be provided for 12 weeks, Week 2-13."
RECRUITING
Rapid Access Addiction Medicine Clinic, St. Paul's Hospital, Vancouver
SUSPENDED
River Stone Recovery Centre, Fredericton
RECRUITING
Center for Addiction and Mental Health, Toronto
RECRUITING
University of Montreal Hospital Research Center, Montreal
Canadian Institutes of Health Research (CIHR)
OTHER_GOV
Centre hospitalier de l'Université de Montréal (CHUM)
OTHER