The Efficacy and Neurobehavioural Mechanism of N-acetyl Cysteine for Alcohol Dependence: An Exploratory Pilot Study
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Study 3: Markers of neural inflammation and responses to alcohol cue
研究概览
简要总结
The study will explore the efficacy and tolerability of a regimen of NAC (2400 mg) versus placebo for the treatment of alcohol dependence.
详细描述
Study 1: Relapse prevention: This is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive oral NAC (2400 mg: 2x 600mg tablets twice per day) or matching placebo. Trial participants will receive either oral NAC ( dose stated above) or matching placebo for up to 4 weeks.
Study 2: Withdrawal: Trial participants will receive oral NAC (dose stated above) or matching placebo within the first 24 hours of their admission for up to 3 days.
Study 3: Participants from the relapse prevention substudy will also receive 30-minute non-invasive brain imaging session prior to and after completing the treatment regime in Study 1.
Both males and females will be recruited for the study.
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)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female patients between the ages of 18 and 65 meeting DSM-IV criteria for current alcohol use disorder (this is an exclusion for the healthy control sample)
- •Able to understand and sign written informed consent
- •Must have a stable residence and be able to identify an individual who could locate subject if needed
- •Admitted for medical detoxification from alcohol (withdrawal study only)
- •Blood alcohol concentration of 0.00 (if completing brain imaging session)
- •Express a desire to achieve abstinence or to greatly reduce alcohol consumption (relapse prevention study only)
排除标准
- •Clinically significant comorbidities or medical disease that might interfere with the evaluation of the study medication or present a safety concern.
- •Pregnant women and women of childbearing potential who do not practice a medically acceptable form of birth control
- •Women who are breastfeeding
- •Dependence on any substance other than nicotine
- •Court-mandated participation in alcohol treatment or pending incarceration (relapse prevention study only)
- •Treatment/ingestion during the previous week of benzodiazepines or other sedative-hypnotic medications or history of recent chronic treatment with sedative-hypnotic medications (withdrawal study only)
- •Dependence on any substance other than nicotine
- •The following exclusion criteria are only applicable to participants undergoing the brain imaging session:
- •Extreme obesity
- •Pregnant or have any reason to believe they are pregnant;
- •Previous brain surgery;
- •Ever employed as a machinist, a welder or a metal worker;
- •Metal items such as pacemakers; aneurysm clips in the brain; metal dental implants; metallic fragments in the eye or anywhere else; insulin pump; metal implants; hearing aid or a prosthetic device.
研究组 & 干预措施
Arm 1
NAC - Relapse Prevention (4 wks)
干预措施: NAC 2400mg/day (Drug)
Arm 2
NAC - Relapse Prevention (4 wks)
干预措施: Placebo (Drug)
结局指标
主要结局
Study 3: Markers of neural inflammation and responses to alcohol cue
时间窗: 4 weeks
as measured by blood oxygen level dependent (BOLD) brain activation differences to alcohol cues (alcohol cue activation)
Study 1: Alcohol consumption
时间窗: 4 weeks
as measured by the abstinence rate, time to relapse and time to lapse
Study 2: Amount of Benzodiazepines administered
时间窗: 3 days
as measured by Alcohol Urge Questionaire (AUQ) Score
次要结局
- Alcohol craving(4 weeks)
- Mood(4 weeks)
研究者
Professor Paul Haber
Clinical Director
South West Sydney Local Health District