A Randomised Controlled Trial of N-acetylcysteine for the Management of Alcohol Use Disorder
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 280
- 试验地点
- 3
- 主要终点
- Heavy Drinking Days
研究概览
简要总结
To explore the effectiveness of n-acetylcysteine in improving treatment outcomes for alcohol use disorder in a double-blind randomised placebo-controlled trial.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double-blind design
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
N-acetyl Cysteine
Generic name: N-acetyl cysteine. Brand: ACC-600 (Acetylcysteine). Strength: 600mg per capsule. Form: capsule Route: oral Frequency: 2x capsules twice per day = total 4 capsules/day Duration: 12 weeks
- Standard of Care: Medical Management.
干预措施: N-acetyl cysteine (Drug)
Placebo
Matched placebo
Generic name: dicalcium phosphate Strength: 600mg per capsule Form: capsule Route: oral Frequency: 2x capsules twice per day = total 4 capsules/day Duration: 12 weeks.
- Standard of Care: Medical Management.
干预措施: Placebo (Drug)
结局指标
主要结局
Heavy Drinking Days
时间窗: 24 weeks
Reduction in Heavy Drinking Days (HDD; defined as 4 or more drinks in a day for women and five or more drinks in a day for men). This will be measured by the Timeline Follow Back and corroborated with Phosphatidylethanol (PEth) levels
次要结局
- Absence of any HDD(24 weeks)
- Changes in Liver Function(24 weeks)