Feasibility of Long-term, High-dose Stimulant for Methamphetamine Use Disorder

PHASE2RecruitingINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

July 18, 2025

Primary Completion Date

August 31, 2027

Study Completion Date

December 31, 2027

Conditions
Methamphetamine AbuseMethamphetamine-dependenceAddictionSubstance AbuseMethamphetamine Use Disorder
Interventions
DRUG

LDX-01 plus TAU

"Participants receive once daily LDX-01 for 25 weeks, as well as TAU at a clinical site. Medication is provided in 3 phases:~Week 1 (Induction Phase): 100 mg (Days 1 and 2), 150 mg (Days 3 and 4), 200 mg (Days 5, 6 and 7); Weeks 2-21 (Maintenance Phase): 250 mg (or the maximum tolerated for each individual) ; Weeks 22-25 (Taper Phase): 200 mg (Week 22), 150 mg (Week 23), 100 mg (Week 24) and 50 mg (Week 25)."

DRUG

Placebo plus TAU

"Participants receive once daily LDX-01-matched placebo for 25 weeks, as well as TAU at a clinical site. Medication is provided in 3 phases:~Week 1 (Induction Phase): 100 mg (Days 1 and 2), 150 mg (Days 3 and 4), 200 mg (Days 5, 6 and 7); Weeks 2-21 (Maintenance Phase): 250 mg (or the maximum tolerated for each individual) ; Weeks 22-25 (Taper Phase): 200 mg (Week 22), 150 mg (Week 23), 100 mg (Week 24) and 50 mg (Week 25)."

Trial Locations (1)

H2X 0A9

RECRUITING

Centre hospitalier de l'Université de Montréal (CHUM), Montreal

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Ministere de la Sante et des Services Sociaux

OTHER

collaborator

Health Canada

OTHER_GOV

lead

Centre hospitalier de l'Université de Montréal (CHUM)

OTHER

NCT06788587 - Feasibility of Long-term, High-dose Stimulant for Methamphetamine Use Disorder | Biotech Hunter | Biotech Hunter