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

PHASE2RecruitingINTERVENTIONAL
Enrollment

440

Participants

Timeline

Start Date

December 5, 2023

Primary Completion Date

November 30, 2025

Study Completion Date

November 30, 2025

Conditions
Methamphetamine AbuseMethamphetamine-dependenceAddiction, SubstanceAddiction
Interventions
DRUG

Treatment as Usual plus Placebo

Participants receive once daily Lisdexamfetamine matched placebo for 15 weeks, as well as treatment as usual at clinical site.

DRUG

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.

DRUG

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)."

DRUG

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."

Trial Locations (4)

Unknown

RECRUITING

Rapid Access Addiction Medicine Clinic, St. Paul's Hospital, Vancouver

E3B 1E3

SUSPENDED

River Stone Recovery Centre, Fredericton

M6J 1HN

RECRUITING

Center for Addiction and Mental Health, Toronto

H2X 0A9

RECRUITING

University of Montreal Hospital Research Center, Montreal

All Listed Sponsors
collaborator

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

lead

Centre hospitalier de l'Université de Montréal (CHUM)

OTHER