Evidence map›Paper›PMID 40921646›Full record

ArticleBMJ open2025

N-acetyl cysteine for the treatment of alcohol use disorder: study protocol for a multi-site, double-blind randomised controlled trial (NAC-AUD study).

Kirsten Morley, Shalini Arunogiri, Jason P Connor, Paul J Clark, Mary Lou Chatterton, Andrew Baillie, Tim Slade, Michael Berk, D Lubman, Paul S Haber

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMJ open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05408247 (A Randomised Controlled Trial of N-acetylcysteine for the Management of Alcohol Use Disorder), which is not on this map. Cited by 1 paper, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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.

NCT05408247 phase4recruitingnot on this map

A Randomised Controlled Trial of N-acetylcysteine for the Management of Alcohol Use Disorder

TypeinterventionalSponsorUniversity of SydneyRan2023 to 2026Enrolled280ConditionsAlcohol Use Disorder (AUD)ArmsN-acetyl cysteine, Placebo
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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

10 authors.

Kirsten MorleySpecialty of Addiction Medicine, The University of Sydney School of Medicine, Sydney, New South Wales, Australia kirsten.morley@sydney.edu.au.ORCID http://orcid.org/0000-0002-0868-9928
Shalini ArunogiriEastern Health Clinical School, Monash University, Box Hill, Victoria, Australia.
Jason P ConnorThe University of Queensland, Saint Lucia, Queensland, Australia.
Paul J ClarkDepartment of Gastroenterology and Hepatology, Princess Alexandra Hospital, Brisbane, Queensland, Australia.
Mary Lou ChattertonMonash University, Clayton, New South Wales, Australia.ORCID http://orcid.org/0000-0003-4902-9448
Andrew BaillieHealth Sciences, University of Sydney, Camperdown, New South Wales, Australia.
Tim SladeMatilda Centre, The University of Sydney, Sydney, New South Wales, Australia.
Michael BerkPsychiatry, Deakin University Faculty of Health Medicine Nursing and Behavioural Sciences, Geelong, Victoria, Australia.
D LubmanEastern Health Clinical School, Monash University, Box Hill, Victoria, Australia.
Paul S HaberSpecialty of Addiction Medicine, The University of Sydney School of Medicine, Sydney, New South Wales, Australia.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionCurrent treatments for alcohol use disorders (AUD) have limited efficacy. A previous 28-day pilot trial of N-acetyl cysteine (NAC) vs placebo found NAC to be feasible and safe, with evidence of improvement on some measures of alcohol consumption. Thus, the primary aim of the NAC-AUD study is to examine the therapeutic and cost-effectiveness of NAC vs placebo in improving treatment outcomes for AUD. We will also examine the (i) effect of NAC vs placebo on mood, markers of liver injury, cognition and hangover symptoms; and (ii) predictors of any response. METHODS AND ANALYSIS: This double-blind trial will randomise participants with AUD to a 12-week regimen of either NAC (2400 mg/day) or placebo. All participants will receive medical management. The primary drinking outcome will be the number of heavy drinking days (HDDs) per week, validated by phosphatidylethanol (PEth). Secondary alcohol-related outcomes will include standard drinks per drinking day (SDDD) per week and absence of any HDDs. Other secondary outcomes will include markers of liver injury, depression, anxiety, craving, hangover symptoms, cognition and blood oxidative stress markers. We will also examine the cost-efficacy of NAC vs placebo. ETHICS AND DISSEMINATION: Ethics approval for the study has been granted by The Sydney Local Health District Ethics Review Committee (X21-0342& HREC2021/ETH11614). There are no restrictions on publication from the sponsor or other parties. TRIAL REGISTRATION NUMBER: NCT05408247.

Indexed as

AcetylcysteineAlcoholismAdultAlcohol DrinkingCognitionCost-Benefit AnalysisDouble-Blind MethodFemaleHumansMaleMulticenter Studies as TopicRandomized Controlled Trials as TopicTreatment OutcomeAcetylcysteineMENTAL HEALTHPSYCHIATRYSubstance misuse

Identifiers

PMID40921646
PMCPMC12421191

What OpenQuestion holds

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Registered trials

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.