RECRUITMENT FOR THE N-ICE TRIAL HAS NOW CLOSED
For information on services available in your area please contact the National Alcohol and Other Drug Hotline on 1800 250 015
In a world first, the N-ICE Trial will study a much needed new approach to treating crystal methamphetamine - or “ice” - dependence.
The N-ICE Trial will establish if N-Acetyl Cysteine (NAC) can reduce craving for ice and help people stop using ice.
Why NAC for ice addiction?
When someone first takes ice, they experience the seemingly desirable effects from being intoxicated with the drug. Then, as they become addicted, there are changes in the brain that cause cravings and make it hard to stop using it.
NAC targets these brain changes that underpin craving and addiction. It helps restore balance to those brain systems, and in doing this, it helps reduce the craving for ice.
Previous studies have shown that NAC can reduce cravings for various drugs, including ice, cocaine, cannabis and tobacco. This trial will find out whether NAC can help people reduce their use of ice or stop using ice altogether.
We also hope that NAC will help reduce the paranoia and mood changes people experience when they become addicted to ice. Some of these symptoms are related to the toxic effects of ice on the brain, and NAC has been found to protect the brain from this toxicity.
Most importantly, we want to make sure that NAC is safe. NAC has been used safely in various other trials, and is an approved medicine for other purposes. We will be assessing whether it is safe take-home medication for people who use ice.
Where is the N-ICE Trial being conducted?
The N-ICE trial is being conducted in Wollongong, Geelong and Melbourne. See below for further details on our study sites and team, or visit us on Facebook.
How long will the trial run for?
The N-ICE trial started in mid-2018 and we expect recruitment of participants will continue until the end of 2019. This may vary depending on the trial site. Please refer to your local trial site for more specific details.
How do I enrol in the trial?
Recruitment has now closed. If you are a trial participant and have questions about your participation, please contact your local trial site (below). For information on treatment options in your area please contact the National Alcohol and Other Drug Hotline on 1800 250 015
Phone Anna on 0415 313 701 or email email@example.com
Phone Ramez on 0434960033 or email firstname.lastname@example.org
Or visit us on Facebook
What does the trial involve?
The trial will involve taking two capsules of NAC morning and night for 12 weeks. During the trial there will be weekly assessments to monitor drug use and mood. All participants must undergo a comprehensive screening interview and medical assessment prior to receiving NAC. Participants must also agree to attend medical assessments during the trial as requested, and a final medical assessment within one month of completing the trial.
Does it cost anything to participate?
Participation in the trial is free.
What happens at the end of the trial?
At the end of the trial, you must have a final medical assessment. We are unable to provide NAC after the end of the trial. However, we will offer you a referral to other services that are available.
Can I get other treatment while I’m on the trial?
Once you are enrolled in the trial, you are free to access other services and treatments provided that this does not prevent you from taking the trial medication, participating in the trial assessments, or put your health at risk. Your trial doctor will make this decision and stop the medication if he or she sees fit.
What if I have a loved one addicted to ice?
Participation in the trial is completely voluntary and each participant must contact us directly to enrol. We cannot take referrals from family, friends, or other health services.
Where else can I get help for ice use?
A number of free and confidential support services are available for people experiencing problems with ice, as well as their family and friends. Call the National Alcohol and Other Drug Hotline on 1800 250 015 to be automatically directed to the Alcohol and Drug Information Service in your state or territory.
For emergency support, call Lifeline on 131 114 or dial '000' for an ambulance or police.
The N-ICE team and trial sites
Our team are an internationally recognised team of researchers who have experience trialling treatments for ice and other drugs, and we have conducted several of the largest trials of NAC in the world. Further details about the trial investigators and their institutions are below.
Dr Olivia Dean, Dr Alyna Turner and Professor Michael Berk , IMPACT Strategic Research Centre, Deakin University and Barwon Health
Dr Peter Higgs, La Trobe University
Olivia Dean, Alyna Turner and Michael Berk
Dan Lubman, Shalini Arunogiri and Victoria Manning
University of Wollongong
Barbara Sinclair and David Reid
Illawarra Drug and Alcohol Service
Greg Carter and Amanda Baker
University of Newcastle
Brendan Quinn and Paul Dietze
La Trobe University
This is a two-arm, parallel, double-blind, placebo-controlled, three-site, randomised (ratio 1:1) trial using permuted block randomisation, with variable block sizes, stratified by site, sex and injecting (vs. non-injecting) methamphetamine use. Participants (N = 180; 60 per site) need to be dependent on methamphetamine, interested in reducing their methamphetamine use, and not currently receiving treatment for substance use disorders. The trial is being conducted in outpatient settings in Melbourne, Geelong and Wollongong, Australia. Participants will receive either 2,400 mg oral NAC or matched placebo, delivered as a take-home medication for 12 weeks (2 x 600 mg capsules, self-administered morning and evening). Adherence is being monitored using eCAP™ medication bottle lids which record the date and time of bottle opening. The primary outcome measure is methamphetamine use during the 12-week trial medication period measured as (a) days of use, assessed using the Timeline Followback, and (b) methamphetamine-positive saliva tests, taken weekly. Secondary measures include weekly assessment of methamphetamine craving, severity of methamphetamine dependence, methamphetamine withdrawal symptoms, and psychiatric symptoms (depression, suicidality, psychotic symptoms and hostility). Adverse events are monitored at each weekly assessment. Tolerability is assessed using the Treatment Satisfaction Questionnaire for Medication.
Ongoing. Please refer to the Australian and New Zealand Clinical Trials Registry (ACTRN12618000366257).
Expected to be available mid-2020
McKetin R, Dean OM, Turner A, Kelly PJ, Quinn B, Lubman DI, Dietze P, Carter G, Higgs P, Baker AL, Sinclair B, Reid D, Manning V, te Pas N, Liang W, Thomas T, Bathish R, Kent M, Raftery D, Arunogiri S, Cordaro F, Hill H, Berk M. A study protocol for the N-ICE trial: A randomised double-blind placebo-controlled study of the safety and efficacy of N-acetyl-cysteine (NAC) as a pharmacotherapy for methamphetamine (“ice”) dependence. Trials. 2019 4;20(1):325
Data can be made available from the project to support PhD and post-doctoral research projects.
The N-ICE trial is the first clinical trial to assess whether NAC can reduce methamphetamine use. This trial will provide a platform for understanding the potential utility of NAC in managing methamphetamine dependence and clinically related outcomes. If found to be effective, take-home NAC could provide a potentially scalable and affordable pharmacotherapy option for methamphetamine dependence.