{
  "abstract": "Introduction Current 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.",
  "authors": [
    {
      "affiliations": [
        "Specialty of Addiction Medicine, The University of Sydney School of Medicine, Sydney, New South Wales, Australia"
      ],
      "name": "Kirsten Morley"
    },
    {
      "affiliations": [
        "Eastern Health Clinical School, Monash University, Box Hill, Victoria, Australia"
      ],
      "name": "Shalini Arunogiri"
    },
    {
      "affiliations": [
        "The University of Queensland, Saint Lucia, Queensland, Australia"
      ],
      "name": "Jason P Connor"
    },
    {
      "affiliations": [
        "Department of Gastroenterology and Hepatology, Princess Alexandra Hospital, Brisbane, Queensland, Australia"
      ],
      "name": "Paul J Clark"
    },
    {
      "affiliations": [
        "Monash University, Clayton, New South Wales, Australia"
      ],
      "name": "Mary Lou Chatterton"
    },
    {
      "affiliations": [
        "Health Sciences, University of Sydney, Camperdown, New South Wales, Australia"
      ],
      "name": "Andrew Baillie"
    },
    {
      "affiliations": [
        "Matilda Centre, The University of Sydney, Sydney, New South Wales, Australia"
      ],
      "name": "Tim Slade"
    },
    {
      "affiliations": [
        "Psychiatry, Deakin University Faculty of Health Medicine Nursing and Behavioural Sciences, Geelong, Victoria, Australia"
      ],
      "name": "Michael Berk"
    },
    {
      "affiliations": [
        "Eastern Health Clinical School, Monash University, Box Hill, Victoria, Australia"
      ],
      "name": "D Lubman"
    },
    {
      "affiliations": [
        "Specialty of Addiction Medicine, The University of Sydney School of Medicine, Sydney, New South Wales, Australia",
        "Drug Health Services, Sydney Local Health District, Camperdown, New South Wales, Australia"
      ],
      "name": "Paul S Haber"
    }
  ],
  "title": "N-acetyl cysteine for the treatment of alcohol use disorder: study protocol for a multi-site, double-blind randomised controlled trial (NAC-AUD study)",
  "uid": "d4277645-5fc4-5b6e-93d4-3d02718483b4"
}