This open-label Phase II pilot study (n=20), registered on ANZCTR with the trial acronym MASKOT, investigates the safety and tolerability of sub-anaesthetic ketamine in young people with methamphetamine use disorder seeking treatment to reduce their methamphetamine use.
Open-label, single-group Phase II pilot (n=20) assessing safety and tolerability of sub-anaesthetic ketamine administered subcutaneously once weekly for two sessions in young people (15–35 years) with methamphetamine use disorder. Dose starts at 0.75 mg/kg (Level 1) with escalation to 0.9 mg/kg (Level 2) after ≥7 days if tolerated; dose may be reduced to 0.6 mg/kg (Level 0) for the second dose if initial dose not tolerated.
Primary outcome is safety, indexed by change from baseline in average past-month occasions of ketamine use (Timeline Follow Back). Secondary outcomes include change in ketamine craving (Brief Substance Craving Scale) with assessments at baseline and Weeks 1, 2, 3, 4 and 6 post-intervention.
Subcutaneous low-dose ketamine once weekly for two sessions with possible escalation or reduction based on tolerability.
Level 1 0.75 mg/kg; Level 2 0.9 mg/kg if tolerated after ≥7 days; Level 0 0.6 mg/kg if Level 1 not tolerated; administered subcutaneously by clinician.