Alcohol Dependence: Study of the Possible Reduction of Compulsion by Association of Naltrexone With Poly-unsaturated Fatty Acids (PUFAs)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- "Drinking Days" in the Previous Month
研究概览
简要总结
Context: The treatment of alcoholism is a challenge for psychiatrists and patients. Some studies have shown that alcohol alters the environment of the membranes, mainly by modifying their permeability through the lipid fraction. These lipids are known as essential fatty acids (EFA) because they are obtained only through the diet, as the human body is unable to synthesize them. Linolenic acid (LA), or omega 6, and alpha-linolenic acid (ALA), or omega 3, are polyunsaturated fatty acids (PUFAs). Finally, ethanol changes the absorption and metabolism of PUFAs, and it's supplementation may be helpful for alcohol dependence recovery.
Objective: to assess the effectiveness of PUFAs supplementation in the treatment of alcohol dependent patients.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •severe alcohol dependence
- •no history of allergic processes, hepatic, cardiovascular, renal, pulmonary, endocrine or neurological pathologies, as well as no history of psychiatric disorders, dependences other than alcohol and/or tobacco, and blood test results outside the reference range
排除标准
- •history of allergic processes, hepatic, cardiovascular, renal, pulmonary, endocrine or neurological pathologies
- •dependences other than alcohol and/or tobacco
- •psychiatric disorders
- •test laboratories results outside the reference range
研究组 & 干预措施
PUFAs
Polyunsaturated fatty acids (PUFAs): borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram; along with 1 gram of fish oil - rich in omega 3 PUFA;
干预措施: PUFAs (Drug)
Naltrexone
Naltrexone chlorhydrate 50 mg
干预措施: Naltrexone (Drug)
Placebo
Naltrexone Placebo: pill with 50mg of talcum powder, identical to the pill of naltrexone;
Polyunsaturated fatty acids Placebo (PUFAs Placebo): yellow liquid paraffin identical to the pills of borage seed and fish oil.
干预措施: Placebo (Drug)
Naltrexone + PUFAs
Polyunsaturated fatty acids (PUFAs): borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram; along with 1 gram of fish oil - rich in omega 3 PUFA;
Naltrexone chlorhydrate 50 mg
干预措施: Naltrexone + Placebo (Drug)
结局指标
主要结局
"Drinking Days" in the Previous Month
时间窗: 3 months
The Alcohol Timeline Followback (TLFB) is a drinking assessment method that obtains estimates of daily drinking and has been evaluated with clinical and nonclinical populations. Using a calendar, people provide retrospective estimates of their daily drinking over a specified time period that can vary up to 12 months from the interview date.
次要结局
- Short Alcohol Dependence Data Questionnaire (SADD)(3 months)
- Obsessive Compulsive Drinking Scale (OCDS)(3 months)