Ketamine-assisted psychotherapy for methamphetamine use disorder

This open-label safety and feasibility pilot trial (n=20) will study ketamine-assisted psychotherapy for methamphetamine use disorder in adults.

The study, titled KAPPA, aims to determine if combining ketamine with cognitive behavioural therapy (CBT) is a safe and feasible treatment approach for methamphetamine use disorder.

Conducted by St Vincent’s Hospital Sydney and funded by the Australian Government Department of Health and Aged Care, the trial involves four weekly CBT sessions, with ketamine administered subcutaneously before the second, third, and fourth sessions. Participants’ safety will be monitored through adverse event reporting and various health assessments.

Feasibility will be evaluated based on recruitment time, session attendance, and participant retention. The trial will commence in September 2024.

Topic Addiction Opioid Use Disorder Alcohol Use Disorder
Compound Ketamine
Country Australia
Visit trial
Status Not yet recruiting
Results Published No
Start date 02 September 2024
End date 30 December 2025
Phase Phase IV
Design Open
Type Interventional
Generation First
Participants 20
Sex All
Age 18- 98
Therapy Yes

Trial Details

This study aims to determine the safety and feasibility of a combination of ketamine and cognitive behavioural therapy (ketamine-assisted therapy) for people with methamphetamine use disorder in an outpatient drug and alcohol treatment setting. There are currently no approved medications in Australia to help people manage, reduce, or stop their methamphetamine use; and psychotherapy is moderately effective. It is hoped that this study will help find out if ketamine-assisted psychotherapy (four sessions of cognitive behavioural therapy with three doses of ketamine, over a four-week period) is a safe and feasible treatment approach for methamphetamine use disorder.

NCT Number ACTRN12624000895583

Sponsors & Collaborators

St Vincent's Hospital Melbourne


Data attribution

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