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.
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.
Manualised 4-session CBT with three adjunctive subcutaneous ketamine doses (weeks 2–4) with dose-escalation based on tolerability.
Manualised CBT (Baker et al. 2003). Sessions ~90 minutes each; session 1 assessment and motivational interviewing; sessions 2–4 include brief integration within 24–48 hours of ketamine dosing; optional 1‑hour booster at week 6.
Subcutaneous ketamine HCl 200 mg/ml administered once weekly in Weeks 2–4. Dose escalation algorithm: Dose1 0.75 mg/kg; Dose2 increase to 0.9 mg/kg if well tolerated (or reduce to 0.75 or 0.6 if less tolerated); Dose3 range 0.5–0.9 mg/kg per tolerability. Direct observation by registered nurse.