MethAmphetamine use in young people: safety and tolerability of Sub-anaesthetic Ketamine, An Open-label Trial

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.

Topic Addiction
Compound Ketamine
Country Australia
Visit trial
Status Recruiting
Results Published No
Start date 10 March 2022
End date 28 February 2023
Phase Phase II
Design Open
Type Interventional
Generation First
Participants 20
Sex All
Age 15- 25
Therapy No

Trial Details

This is an open-label Phase II pilot study to investigate the safety and tolerability of two doses of ketamine in young people with stimulant use disorder, methamphetamine-type seeking treatment to reduce their methamphetamine use. The study treatments will be provided in addition to treatment-as-usual received by participants during their regular clinical care. All participants will be engaged with a GP or psychiatrist, either through headspace, Orygen, or in the community, and they will be offered referral into outpatient alcohol and other drug treatment at headspace or in the community. They will receive psychiatric and medical review by the study doctor during screening and at weeks 1 and 2. Participants will complete comprehensive screening and baseline testing. They will then undergo two ketamine administration sessions (subcutaneous; initial dose 0.75 mg/kg) separated by at least 7 days. Assessments will occur at baseline and weeks 2, 3, 4, and 6.

NCT Number ACTRN12621000528853

Data attribution

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