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

Обзор

To explore the effectiveness of n-acetylcysteine in improving treatment outcomes for alcohol use disorder in a double-blind randomised placebo-controlled trial.

Подробное описание

Australia urgently requires new treatment strategies for the treatment of alcohol dependence. Although alcohol use disorders are a leading cause of preventable death in Australia, their treatment is generally not evidence based. The medications currently approved for use in Australia for the management of alcohol dependence have limited efficacy, and existing research does not address the heterogeneity of treatment response. Targeted personalised medicine addresses this heterogeneity with better medicine selection for patients based on their genotype and clinical comorbidities.

Following on from a recent pilot study conducted by CI Morley (NCT03879759), this project will evaluate the clinical efficacy and tolerability of NAC, relative to a placebo, in heavy drinkers. We hypothesise that NAC-treated participants will be better able to achieve a reduction in heavy drinking. We will utilise a double-blind, randomised, controlled design. A sample of 280 individuals will receive 12 weeks of treatment with NAC (2400 mg/day) or placebo.

Вмешательства

• Препарат N-acetyl cysteine
  2400mg/day
• Препарат Placebo
  Matched placebo

Первичные конечные точки

• Heavy Drinking Days [Срок оценки: 24 weeks]

Вторичные конечные точки (2)

• Changes in Liver Function [Срок оценки: 24 weeks]
• Absence of any HDD [Срок оценки: 24 weeks]

Критерии участия

Критерии включения

• Alcohol Use Disorder according to the DSM-V criteria
• A desire to reduce or stop drinking
• Consumed at least 21 standard drinks per week or 2 heavy drinking days per week (HDD: ≥ 5 standard drinks/day for men; ≥4 for women) in the month prior to screening
• Adequate cognition and English language skills to give valid consent and complete research interviews
• Stable housing
• Willingness to give written informed consent

Критерии исключения

• Pregnancy or lactation (women will be advised to use reliable contraception during the trial and a pregnancy test will be performed were necessary)
• Concurrent use of any psychotropic medication other than antidepressants (provided these are taken at stable doses for at least two months)
• Any substance dependence other than nicotine
• Clinically unstable systemic medical (e.g. cancer, end stage liver disease: e.g. MELD score ≥ 10) or psychiatric disorder (e.g. active psychosis, borderline personality disorder, active suicide risk: e.g. MADRAS item 10 score of 6) that precludes trial participation
• Concurrent use of selenium, vitamin D or other anti-oxidants
• Any alcohol pharmacotherapy within the past month

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Австралия · 3 центра

• Drug Health Services, Royal Prince Alfred Hospital — Sydney
• Cornwall Street Medical Centre (UQ Health Care) — Annerley
• Turning Point — Richmond

Публикации

• Morley K, Arunogiri S, Connor JP, Clark PJ, Chatterton ML, Baillie A, Slade T, Berk M, Lubman D, Haber PS. N-acetyl cysteine for the treatment of alcohol use disorder: study protocol for a multi-site, double-blind randomised controlled trial (NAC-AUD study). BMJ Open. 2025 Sep 8;15(9):e091631. doi: 10.1136/bmjopen-2024-091631. PMID 40921646

Идентификаторы

NCT: NCT05408247 · X21-0342

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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