Adjunctive N-Acetyl Cysteine on craving in patients with alcohol dependence syndrome and its neurometabolite correlates: an H MRS based study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Reduction in craving as measured by Alcohol craving questionnaire (ACQ-NOW) and Obsessive compulsive drinking scale
研究概览
简要总结
This proposed hospital-based, open-label clinical trial at the Central Institute of Psychiatry aims to assess the efficacy of adjunctive N-Acetyl Cysteine (NAC) (2400 mg/day) on alcohol craving and brain glutamate levels in the nucleus accumbens over a 4-weekperiod. A total of 40 right-handed male ADS patients aged 18–60 years, post-detoxification, will be randomized into two groups: one receiving NAC with treatment as usual (TAU) and the other receiving only TAU.
Craving will be measured using validated tools like ACQ-NOW and OCDS, and glutamate levels will be assessed through Proton Magnetic Resonance Spectroscopy (MRS). Weekly monitoring for side effects will be conducted using the SAFTEE checklist. Statistical analysis will include comparison of craving scores and glutamate levels between groups and correlation with socio-demographic and clinical variables.
This study seeks to explore NAC as a novel, safe, and effective adjunct treatment for reducing craving and relapse in ADS, with a neurobiological basis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- Male
入选标准
- •Male patients diagnosed with Alcohol Dependence Syndrome as per International Classification of Disease.
- •11th revision -Diagnostic Criteria for Research.
- •Age between 18 to 60 years
- •Patients with history of relapse.
- •The Clinical Institute Withdrawal Assessment for Alcohol (revised version) CIWA-Ar lesser than or equal to
- •Right-handed
- •Patients who are ready to give informed consent.
排除标准
- •Alcohol dependence having any other co-morbid substance dependence
- •Patients having any medical illness
- •Patients having any other psychiatric illness, organic brain disorder, clinically diagnosed intellectual disability.
- •Patients having any metallic implants/ parts in body.
- •Severity of Alcohol Dependence Questionnaire (SADQ) less than 16.
结局指标
主要结局
Reduction in craving as measured by Alcohol craving questionnaire (ACQ-NOW) and Obsessive compulsive drinking scale
时间窗: 0th and 4th week
次要结局
- Significant difference in level of Gluatamte after administration of adjuvanr N Acetyl Cysteine over treatment as usual(0th and 4th week)
研究者
Vijay Rana
Central Institute of Psychiatry