Ketamine-assisted psychotherapy for methamphetamine use disorder
Open-label, non-randomised Phase IV pilot (n=20) evaluating safety and feasibility of manualised 4-session CBT with three adjunctive subcutaneous ketamine doses (weekly, weeks 2–4) for adults with methamphetamine use disorder.
Details
Participants receive a manualised four-session CBT programme over four weeks with integration; three subcutaneous ketamine doses are administered once weekly in Weeks 2–4 with an escalation algorithm based on tolerability.
Ketamine dosing: initial 0.75 mg/kg SC, possible increase to 0.9 mg/kg if well tolerated; subsequent dosing adjusted to tolerability (range 0.5–0.9 mg/kg). Doses given by registered nurse under observation.
Safety is the primary focus: weekly clinic visits collect adverse events (KSET), vitals, dissociative effects, suicidality, and non-medical use liability; DSMB oversight. Outcomes include change in past 28-day methamphetamine use assessed weekly to Week 5 and at Weeks 8, 12 and 24.