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

image - TINA Trial
Date Commenced:
June 1 2021
Expected Date of Completion:
May 31 2025
Project Supporters:

 

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

 

Drug Type:
Project Members: 
image - Rebecca McKetin   Lo Rez Uncropped Linkedin
Associate Professor
Ph 02 93850331 (Ext x 50294)
image - Michael Farrell 0
Director
Ph EA Tori Barnes: 02 9385 0292 / t.barnes@unsw.edu.au
Project Main Description: 

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.

 

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

Rationale: 

 

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.

 

Aims: 

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 will commence from June 1 2021. Recruitment will start in early 2022.

 

Opportunities (Scholarships, Grants and Research Positions): 

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

Project Research Area: 
Drug Type: 
Project Status: 
Current