The N-ICE trial: A randomised controlled trial of the safety and efficacy of N-Acetyl Cysteine (NAC) as a pharmacotherapy for methamphetamine (‘ice’) dependence
March 2017
Staff:
NDRI:
Associate Professor Rebecca McKetin (Principal Investigator)
Dr Wenbin Liang (Associate Investigator)
Other investigators:
Chief Investigators:
Dr Olivia Dean, Deakin University
Professor Dan Lubman, Monash University
Professor Paul Dietze, Burnet Institute
Dr Peter Higgs, La Trobe University
Dr Peter Kelly, University of Wollongong
Dr Alyna Turner, Deakin University
Dr Brendan Quinn, Burnet Institute
Professor Gregory Carter, Calvary Mater Newcastle Hospital
Associate Investigators:
Professor Amanda Baker, University of Newcastle
Professor Michael Berk, Deakin University
Dr Barbara Sinclair, Wollongong Hospital
Dr David Reid, Drug and Alcohol Services, Wollongong
Dr Ruth Collins, Drug and Alcohol Clinical Services, Barwon Health
Project description:
Crystal methamphetamine (‘ice’) is a significant and growing public health concern in Australia. An estimated 160,000 Australians are now dependent on methamphetamine. Currently, there are no approved medications to treat methamphetamine dependence.
N-acetyl-cysteine (NAC) is a promising pharmacotherapy for methamphetamine dependence. NAC is a glutamatergic agent that helps restore homeostasis to brain systems compromised in addiction. It has shown signs of efficacy in multiple addictions (cocaine, cannabis and tobacco) and has particular potential for methamphetamine dependence because of its multiple actions, which aid in the management of comorbid psychiatric symptoms, and which protect against methamphetamine neurotoxicity.
A recent Phase I trial (N = 23) of NAC for methamphetamine dependence in humans found a large reduction in craving, good adherence to non-supervised dosing, no serious adverse events, and that NAC was well-tolerated, indicating the need for a Phase II trial.
NDRI, in collaboration with Deakin University, Monash University, the University of Wollongong, the University of Newcastle, La Trobe University, the Burnet Institute and Turning Point, will conduct a world-first, Phase IIb, double-blind randomised placebo-controlled trial (N = 180) to assess the safety and efficacy of NAC as a medication for methamphetamine dependence. This multi-site, 12-week trial will be powered to confirm whether NAC has a clinically relevant benefit on methamphetamine use and a range of related clinical outcomes. The trial will use a pragmatic and inclusive design with feasible implementation procedures that will establish realistic treatment effects and facilitate translation into practice.
Oral NAC is cheap, available as an over-the-counter medication in the USA and the European Union, and can be provided as a PBS schedule 4 medication in Australia, allowing it to be delivered as a prescribed medication with minimal clinical supervision in an out-patient setting. If found to be effective, translation of this medication into practice will have far reaching clinical and public health implications, potentially leading to a cost-effective treatment option for methamphetamine dependence.
NDRI is seeking PhD scholars and post-doctoral fellows to research methamphetamine (“ice”) use in Australia, including the N-ICE trial. Curtin University offers post-graduate scholarships and Early Career Researcher Fellowships. For further information contact Associate Professor Rebecca McKetin on 08 9266 1602 or email rebecca.mcketin@curtin.edu.au.
