Crystalline methamphetamine (“ice”) is a growing concern in Australia. There are no approved medications that can be used to treat dependence on this drug. This clinical trial will examine whether mirtazapine, a newly identified treatment agent for methamphetamine use, can be used safely and effectively in routine clinical care to manage methamphetamine dependence in Australia.
Professor Gregory Dore, Kirby Institute UNSW
Professor Steven Shoptaw, University of California Los Angeles (UCLA)
Associate Professor Peter Kelly, University of Wollongong
Dr Alyna Turner, Deakin University
Dr Philip Clare, University of Sydney
Dr Shalini Arunogiri, Monash University
Professor Michael Berk, Deakin University
Associate Professor Olivia Dean, Deakin University
Dr Barbara Sinclair, Illawarra Shoalhaven Local Health District
David Reid, Illawarra Shoalhaven Local Health District
Dr Jeremy Hayllar, Metro North Hospital and Health Service
Dr David Goodman, University of California Los Angeles (UCLA)
Dr Michael Christmass, Mental Health Commission, WA
Juanita Koeijers, National Mental Health Consumer and Carer Forum
There are currently no approved pharmacotherapies that can be delivered as scalable and cost-effective treatment options for methamphetamine dependence. Mirtazapine has recently been identified as a promising medication based on two Phase II clinical trials. Mirtazapine is currently an approved generic antidepressant medication that can be delivered as a prescribed take-home medication, making it a potentially scalable and cost-effective treatment option.
To assess the effectiveness, safety, tolerability of mirtazapine for methamphetamine dependence in routine clinical care.
A Phase III double-blind placebo-controlled randomised trial (N = 340). Participants will be assigned to receive either 12 weeks of mirtazapine or equivalent placebo. Trial sites will include Geelong, Wollongong, Brisbane and Perth. Further trial sites to be confirmed.
The project will commence from June 1 2021. Recruitment will start in early 2022.
Opportunities exist to undertake PhD research in conjunction with this project. Contact project investigators for details.