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.
Conducted by A/Prof Gillinder Bedi from Orygen National in Australia, the study aims to assess the effects of two doses of ketamine administered subcutaneously once a week for two weeks, with the initial dose at 0.75 mg/kg and the second dose at 0.9 mg/kg.
Participants, aged between 15 to 25 years old, will undergo comprehensive screening and baseline testing, followed by two ketamine administration sessions separated by at least 7 days. Assessments will occur at baseline and weeks 2, 3, 4, and 6, focusing on intervention safety, liver function, ketamine craving, ketamine use, adverse drug effects, pulse change, abuse liability-related subjective effects, psychotic-like drug effects, consent ability, completion of ketamine sessions, methamphetamine use, depression symptoms, anxiety, distress, functioning, sleep, quality of life, and other substance use. The study, funded by the National Centre for Clinical Research on Emerging Drugs, aims to recruit 20 participants in Victoria, Australia, with anticipated recruitment dates from 17/05/2021 to 30/12/2022.
Trial Details
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