The Tina Trial: A Phase III randomised placebo-controlled trial of mirtazapine as a pharmacotherapy for methamphetamine “Ice” dependence

For further information about what the trial involves, and participation, please click here.

Project Collaborators External

• 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

Project Supporters

National Health and Medical Research Council (MRFF Efficient Use of existing medicines). Grant No. 2007155

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.

Design and Method

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.

Progress/Update

The project has commenced, and we anticipate recruitment will be open from October 2022. To find out more about recruitment please click here.

Opportunities

We’re looking for someone to work with us on this project! Find out more about the job opportunity here.