Evidence map›Paper›PMID 31164169›Full record

ArticleTrials2019

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.

Rebecca McKetin, Olivia M Dean, Alyna Turner, Peter J Kelly, Brendan Quinn, Dan I Lubman, Paul Dietze, Gregory Carter, Peter Higgs, Amanda L Baker and 13 more

Open access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
2.5field-weighted citation impact, top 11% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 1 synthesis or guideline pooled it, 18 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Article
  5. Review
  6. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

23 authors at 8 institutions in 1 country.

Rebecca McKetinNational Drug Research institute, Curtin University, GPO Box 1987, Perth, WA, 6845, Australia. rebecca.mcketin@curtin.edu.au.ORCID http://orcid.org/0000-0003-2833-4830
Olivia M DeanIMPACT Strategic Research Centre, School of Medicine, Deakin University, Barwon Health, Geelong, Australia.
Alyna TurnerIMPACT Strategic Research Centre, School of Medicine, Deakin University, Barwon Health, Geelong, Australia.
Peter J KellyIllawarra Health and Medical Research Institute and School of Psychology, University of Wollongong, Wollongong, Australia.
Brendan QuinnBehaviours and Health Risks Program, Burnet Institute, Melbourne, Australia.
Dan I LubmanEastern Health Clinical School, Faculty of Medicine, Nursing & Health Sciences, Monash University, Melbourne, Australia.
Paul DietzeBehaviours and Health Risks Program, Burnet Institute, Melbourne, Australia.
Gregory CarterSchool of Medicine and Public Health, University of Newcastle, Callaghan, Australia.
Peter HiggsSchool of Psychology and Public Health, La Trobe University, Melbourne, Australia.
Amanda L BakerSchool of Medicine and Public Health, University of Newcastle, Callaghan, Australia.
Barbara SinclairDrug and Alcohol Services, Illawarra Shoalhaven Local Health District, Wollongong, Australia.
David ReidDrug and Alcohol Services, Illawarra Shoalhaven Local Health District, Wollongong, Australia.
Victoria ManningEastern Health Clinical School, Faculty of Medicine, Nursing & Health Sciences, Monash University, Melbourne, Australia.
Nina Te PasNational Drug Research institute, Curtin University, GPO Box 1987, Perth, WA, 6845, Australia.
Wenbin LiangNational Drug Research institute, Curtin University, GPO Box 1987, Perth, WA, 6845, Australia.
Tamsin ThomasIllawarra Health and Medical Research Institute and School of Psychology, University of Wollongong, Wollongong, Australia.
Ramez BathishEastern Health Clinical School, Faculty of Medicine, Nursing & Health Sciences, Monash University, Melbourne, Australia.
Margaret KentIMPACT Strategic Research Centre, School of Medicine, Deakin University, Barwon Health, Geelong, Australia.
Dayle RafteryIllawarra Health and Medical Research Institute and School of Psychology, University of Wollongong, Wollongong, Australia.
Shalini ArunogiriEastern Health Clinical School, Faculty of Medicine, Nursing & Health Sciences, Monash University, Melbourne, Australia.
Frank CordaroDrug and Alcohol Services, Illawarra Shoalhaven Local Health District, Wollongong, Australia.
Harry HillBarwon Health Drug and Alcohol Services, Geelong, Australia.
Michael BerkIMPACT Strategic Research Centre, School of Medicine, Deakin University, Barwon Health, Geelong, Australia.
Barwon Health · AUEastern Health · AUCurtin University · AUIllawarra Shoalhaven Local Health District · AUUniversity of Wollongong · AUBurnet Institute · AUUniversity of Newcastle Australia · AULa Trobe University · AU

Funding

Australian National Health and Medical Research Council 1128147
6 · The paper itself

Abstract

backgroundThere 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/

designThis 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 registrationAustralian and New Zealand Clinical Trials Registry, ACTRN12618000366257 . Registered on 29 May 2018.

Indexed as

Central Nervous System StimulantsMethamphetamineAcetylcysteineAdolescentAdultAmphetamine-Related DisordersAustraliaClinical Trials, Phase II as TopicCravingDouble-Blind MethodFemaleHumansMaleMiddle AgedMulticenter Studies as TopicRandomized Controlled Trials as TopicAcetylcysteineCentral Nervous System StimulantsMethamphetamineaggressionclinical trialcravingdepressionmethamphetamineN-acetylcysteinepsychosissubstance use disorderssuicidewithdrawal

Identifiers

PMID31164169
PMCPMC6549263
OpenAlexW2948546252

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.