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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
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, Volume 20, No. 1, Article 325, Year 2019
Notification
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Description
Background: There are currently no approved pharmacotherapies for managing methamphetamine dependence. N-acetylcysteine (NAC) has been found to reduce the craving for methamphetamine and other drugs, but its effect on methamphetamine use and other clinically related endpoints are uncertain. The N-ICE trial is evaluating the safety and efficacy of NAC as a take-home pharmacotherapy for methamphetamine dependence. Methods/design: This is a two-arm parallel double-blind placebo-controlled three-site randomised trial (ratio 1:1) using permuted block randomisation, with variable block sizes. It is stratified by site, sex and whether the methamphetamine is injected or not. 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 2400 mg oral NAC or a matched placebo, delivered as a take-home medication for 12 weeks. Two 600 mg capsules are self-administered in the morning and two more in the evening. Adherence is being monitored using eCAP™ medication bottle lids, which record the date and time of each occasion the bottle is opened. The primary outcome 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. Discussion: The N-ICE trial is the first clinical trial to assess whether NAC can reduce methamphetamine use. This trial will improve our understanding of the potential utility of NAC in managing methamphetamine dependence and clinically related outcomes. If found to be effective, take-home NAC could be a potentially scalable and affordable pharmacotherapy option for treating methamphetamine dependence. Trial registration: Australian and New Zealand Clinical Trials Registry, ACTRN12618000366257. Registered on 29 May 2018. © 2019 The Author(s).
Authors & Co-Authors
McKetin, Rebecca
Australia, Perth
Curtin University
Dean, Olívia May
Australia, Geelong
Barwon Health
Australia, Melbourne
The Florey
Australia, Melbourne
University of Melbourne
Turner, Alyna
Australia, Geelong
Barwon Health
Australia, Melbourne
University of Melbourne
Australia, Callaghan
The University of Newcastle, Australia
Dietze, Paul M.
Australia, Melbourne
Burnet Institute
Carter, Gregory Leigh
Australia, Callaghan
The University of Newcastle, Australia
Manning, Victoria C.
Australia, Clayton
Monash University
Australia
Eastern Health
Arunogiri, Shalini
Australia, Clayton
Monash University
Australia
Eastern Health
Berk, Michael
Australia, Geelong
Barwon Health
Australia, Melbourne
The Florey
Australia, Melbourne
University of Melbourne
Australia, Melbourne
Orygen Youth Health
Statistics
Citations: 16
Authors: 8
Affiliations: 11
Identifiers
Doi:
10.1186/s13063-019-3450-0
ISSN:
17456215
Research Areas
Disability
Health System And Policy
Mental Health
Substance Abuse