The Effect of N-acetylcysteine (NAC) on Treatment of Alcohol and Cocaine Use Disorders: A Double-Blind Randomized Controlled Trial.
试验速览
- 阶段
- 4 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Number of participants who attended all study appointments
研究概览
简要总结
This study evaluates the use of N-acetylcysteine in the treatment of alcohol and cocaine use disorders. Alcohol users will be split in two groups, one will receive the active N-acetylcysteine and the other placebo. The same division will occur with cocaine users. The effects of N-acetylcysteine in adherence, abstinence, psychiatric symptoms and stress biomarkers will be evaluated.
详细描述
N-acetylcysteine acts replenishing the human body glutathione storages. Glutathione is an important antioxidant agent, and also modulates the N-methyl-D-aspartate (NMDA) glutamatergic receptor. Glutamate has been associated with the neuroadaptation related to substance use disorders, and thus it is considered a potential target for pharmacological interventions regarding these disorders. N-acetylcysteine also interacts with the cystine-glutamate antiporter on astrocytes hence increasing glutamate release into the extracellular space.
N-acetylcysteine effects and its implications in the addiction disorders have been studied initially with animal models. Glutamate levels normalization through N-acetylcysteine reduced compulsive drug self-administration and drug-seeking behavior in mice. In addition, there are promising results also with human subjects, showing benefits for cocaine, alcohol and cannabis use disorders.
This study consists of a randomized, double-blind, placebo controlled trial with four arms: alcohol users divided into NAC vs Placebo and cocaine users divided into NAC vs 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)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Diagnostic of Alcohol or Cocaine Use Disorder
- •Seven days of inpatient treatment in an addiction treatment specialized unit
排除标准
- •Another Substance Use Disorder (exception: tobacco)
- •Severe medical conditions (cardiac, renal or hepatic), that preclude subject participation
- •History of asthma or convulsions medication use
- •Recent use (<14 days) of any medication that could interfere with the study medication
- •History of anaphylactic reactions with the study medication
- •Suicide risk
- •Inability to understand the informed consent form or to comply with the study requirements
- •Any severe neuropsychiatric condition, not caused by the substance use, that requires specific medication treatments and could interfere with the study development, in the investigators opinion (for instance: dementia, schizophrenia or other psychoses, multiple sclerosis, severe depression, stroke, epilepsy, bipolar disorder)
- •Failing to complete the screening procedures prior to the study first week
研究组 & 干预措施
Alcohol N-acetylcysteine
600 mg N-acetylcysteine capsule by mouth, every 12 hours for 8 weeks
干预措施: Alcohol N-acetylcysteine (Drug)
Alcohol Placebo
A placebo capsule matching color and smell of the active medication
干预措施: Alcohol Placebo (Drug)
Cocaine N-acetylcysteine
600 mg N-acetylcysteine capsule by mouth, every 12 hours for 8 weeks
干预措施: Cocaine N-acetylcysteine (Drug)
Cocaine Placebo
A placebo capsule matching color and smell of the active medication
干预措施: Cocaine Placebo (Drug)
结局指标
主要结局
Number of participants who attended all study appointments
时间窗: 8 weeks
Completers (i.e. subjects who attended all study appointments) vs non-completers
次要结局
- Abstinence by urine(8 weeks)
- BDNF(8 weeks)
- CAT(8 weeks)
- Carbonyl(8 weeks)
- Change in scores of CGI(8 weeks)
- Change in scores of FAST(8 weeks)
- Abstinence by self report(8 weeks)
- Days of inpatient treatment(Up to 4 weeks)
- GSSG(8 weeks)
- GSH(8 weeks)
- GPx(8 weeks)
- Anxiety symptoms(8 weeks)
- TBARS(8 weeks)
- SOD(8 weeks)
- Abstinence by breathalyzer(8 weeks)
- Depressive symptoms(8 weeks)