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NCCRED Clinical Research Seed Funding

An open-label pilot study of sub-anaesthetic ketamine for methamphetamine abuse in young people

Amount awarded: $99,703.00

Principal Investigator: Dr Gill Bedi, Orygen.

An open-label pilot study of sub-anaesthetic ketamine for methamphetamine abuse in young people

Amount awarded: $99,703.00

Principal Investigator: Dr Gill Bedi, Orygen.

Stimulant use disorder, methamphetamine type (SUD-MA) is a chronic, relapsing condition with adverse health and psychosocial consequences. SUD-MA typically onsets in adolescence/early adulthood, conferring additional impacts on the developmental trajectory. Gold standard treatment for substance use disorders includes both psychotherapeutic and pharmacotherapeutic interventions. While various approaches are being investigated, to date there are no efficacious medications for SUD-MA. There is thus a compelling need for efficacious pharmacological options for this indication. One novel approach is to target glutamatergic neuroplastic alterations believed to occur during the transition from use to abuse of a range of addictive drugs. The widely used dissociative anesthetic ketamine is an N-methyl-D-aspartate receptor (NMDAR) antagonist. Compelling clinical data show that single or repeated sub-anesthetic ketamine doses produce rapid improvements in depression that persist well beyond drug clearance, for up to 7 days. Data also suggest that modulation of the glutamatergic system using ketamine may also reduce drug use in substance use disorder, including in users of other psychostimulants (cocaine).

We will conduct a pilot open-label trial (N=20), testing the safety and tolerability of two sub-cutaneous doses of ketamine (initial dose 0.75 mg/kg) in healthy young people (15-25 years old) with SUD-MA. We focus on youth because early intervention provides maximal return on investment economically and in individual patient outcomes. Participants will undergo comprehensive screening and baseline measurement, followed by 2 doses of ketamine separated by 1 week, with 4 weeks follow-up. Safety will be indexed with change from baseline in ketamine use, and assessment of liver function after ketamine treatment. Tolerability will be assessed as the number of participants withdrawing from the study due to adverse medication effects. These data will be employed as pilot data for larger grant applications, thus providing a critical foundation for comprehensive assessment of this promising new pharmacotherapeutic approach for SUD-MA.

Dr Gill Bedi, Chief Investigator A

The University of Melbourne, Orygen National

Dr Christopher Davey, Chief Investigator B

The University of Melbourne, Orygen National

Dr Eddie Mullen, Chief Investigator C

Orygen National

Dr Enrico Cementon, Chief Investigator D

Orygen National

Dr Aswin Ratheesh, Chief Investigator E

The University of Melbourne, Orygen National

Dr Andrew Chanen, Chief Investigator F

The University of Melbourne, Orygen National

Dr Shalini Arunogiri, Chief Investigator G

Monash University; Eastern Health

Dr Orli Schwartz , Chief Investigator H

The University of Melbourne, Orygen National