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

McKetin, Rebecca, Dean, Olivia M, Turner, Alyna, Kelly, Peter J, Quinn, Brendan, Lubman, Dan I, Dietze, Paul, Carter, Gregory, Higgs, Peter, Baker, Amanda L, Sinclair, Barbara, Reid, David, Manning, Victoria, Te Pas, Nina, Liang, Wenbin, Thomas, Tamsin, Bathish, Ramez, Kent, Margaret, Raftery, Dayle, Arunogiri, Shalini, Cordaro, Frank, Hill, Harry and Berk, Michael 2019, 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, vol. 20, pp. 1-11, doi: 10.1186/s13063-019-3450-0.

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Title 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
Author(s) McKetin, Rebecca
Dean, Olivia MORCID iD for Dean, Olivia M orcid.org/0000-0002-2776-3935
Turner, AlynaORCID iD for Turner, Alyna orcid.org/0000-0001-7389-2546
Kelly, Peter J
Quinn, Brendan
Lubman, Dan I
Dietze, Paul
Carter, Gregory
Higgs, Peter
Baker, Amanda L
Sinclair, Barbara
Reid, David
Manning, Victoria
Te Pas, Nina
Liang, Wenbin
Thomas, Tamsin
Bathish, Ramez
Kent, Margaret
Raftery, Dayle
Arunogiri, Shalini
Cordaro, Frank
Hill, Harry
Berk, MichaelORCID iD for Berk, Michael orcid.org/0000-0002-5554-6946
Journal name Trials
Volume number 20
Article ID 325
Start page 1
End page 11
Total pages 11
Publisher BioMed Central
Place of publication London, Eng.
Publication date 2019-06-04
ISSN 1745-6215
Keyword(s) N-acetylcysteine
aggression
clinical trial
craving
depression
methamphetamine
psychosis
substance use disorders
suicide
withdrawal
Science & Technology
Life Sciences & Biomedicine
Medicine, Research & Experimental
Research & Experimental Medicine
Summary 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.
Language eng
DOI 10.1186/s13063-019-3450-0
Indigenous content off
Field of Research 1102 Cardiorespiratory Medicine and Haematology
1103 Clinical Sciences
HERDC Research category C1 Refereed article in a scholarly journal
Copyright notice ©2019, The Author(s)
Persistent URL http://hdl.handle.net/10536/DRO/DU:30122602

Document type: Journal Article
Collections: Faculty of Health
School of Medicine
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