Findings from 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
Presenter: Rebecca McKetin
Author names: Rebecca McKetin1, Olivia M. Dean2,3,4, Alyna Turner2,4,5, Peter J. Kelly6 , Brendan Quinn7, Dan I. Lubman8,9, Paul Dietze7, Gregory Carter5, Peter Higgs10, Amanda L. Baker5, Barbara Sinclair11, David Reid11, Victoria Manning8,9, Tamsin Thomas6, Ramez Bathish8,9, Dayle Raftery6, Anna Wrobel2, Shalini Arunogiri8,9, Frank Cordaro11, Harry Hill12, Mohammadreza Mohebbi2,, Michael Berk2,3,4,13
Author affiliation: 1 National Drug and Alcohol Research Centre, University of New South Wales 2 Deakin University, IMPACT Strategic Research Centre, School of Medicine; 3 Florey Institute for Neuroscience and Mental Health, University of Melbourne; 4 Department of Psychiatry, University of Melbourne; 5 School of Medicine and Public Health, University of Newcastle; 6 Illawarra Health and Medical Research Institute and School of Psychology, University of Wollongong 7 Behaviours and Health Risks Program, Burnet Institute 8 Eastern Health Clinical School, Faculty of Medicine, Nursing & Health Sciences, Monash University 9 Turning Point, Eastern Health, Richmond; 10 School of Psychology and Public Health, La Trobe University; 11 Drug and Alcohol Services, Illawarra Shoalhaven; 12 Barwon Health Drug and Alcohol Services; 13 Orygen, The National Centre of Excellence in Youth Mental Health, University of Melbourne
Introduction: There are currently no approved pharmacotherapies to manage methamphetamine dependence. N-Acetyl Cysteine (NAC) has been found to reduce craving for methamphetamine, but effects on methamphetamine use or clinically related endpoints have not been tested.
Aims: We evaluate the safety and efficacy of NAC as a take-home pharmacotherapy for methamphetamine dependence.
Background: There are currently no approved pharmacotherapies to manage methamphetamine dependence. N-Acetyl Cysteine (NAC) has been found to reduce craving for methamphetamine, but effects on methamphetamine use or clinically related endpoints have not been tested. We evaluate the safety and efficacy of NAC as a take-home pharmacotherapy for methamphetamine dependence.
MethodS: A parallel, double-blind, randomised placebo-controlled trial conducted in Wollongong, Melbourne and Geelong, Australia. Participants (N = 153) were dependent on methamphetamine, interested in reducing their methamphetamine use, and not currently receiving treatment for substance use disorders. Participants were randomized (1:1) to 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 was monitored using eCAP™ medication bottle lids. The primary outcome was 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 included methamphetamine craving, severity of methamphetamine dependence, methamphetamine withdrawal symptoms, and psychiatric symptoms. Tolerability was assessed using the Treatment Satisfaction Questionnaire for Medication version II.
Results: To be confirmed (will be available mid-2020)
Implications for policy and practice: 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. Trial Registration: Version 3.0 of the protocol (dated 29 May, 2018) is registered with the Australian and New Zealand Clinical Trials Registry (ACTRN12618000366257).