This randomised, double-blind, placebo-controlled trial (n=120) will study the efficacy of intravenous (IV) ketamine versus IV midazolam in treating adults with moderate to severe methamphetamine use disorder (MUD).
This is a 12-week randomised, triple-blind, parallel-group trial comparing IV ketamine (0.50 mg/kg) to IV midazolam (0.02 mg/kg) delivered as eight infusions over six weeks in adults with moderate to severe methamphetamine use disorder.
All participants receive weekly medical management during weeks 1–6 and weekly cognitive behavioural therapy on non-infusion days for 12 weeks; outcomes include feasibility, safety, and efficacy to inform larger multi-site trials.
IV ketamine infusions (0.50 mg/kg) administered 8 times over 6 weeks.
Infusions administered over ~45 minutes in 100 mL 0.9% sodium chloride; duration may be extended by clinician.
IV midazolam infusions (0.02 mg/kg) administered 8 times over 6 weeks as active comparator.
Midazolam (Versed) 0.02 mg/kg dissolved in 0.9% sodium chloride; encoded as active comparator (compound set to placebo reference)