Cholesterol and Fatty Acids in Cocaine Addiction Relapse
试验速览
- 阶段
- 2 期
- 状态
- 已完成
研究概览
简要总结
Many substance dependent individuals continue to abuse a variety of substances during treatment for their disorder. Often, substance dependent individuals are co-diagnosed with depression and violence problems. Supplements of n-3 polyunsaturated fatty acids (PUFAs) may play a role in treating individuals with such substance abuse problems. The purpose of this study is to evaluate the effectiveness of the n-3 PUFAs eicosapentaenoic acid (EPA) and docosapentaenoic acid (DPA) in treating relapse, aggression, and depression in substance dependent individuals.
详细描述
Past research suggests that low levels of some PUFAs play a role in the pathophysiology of depressive and aggressive disorders. In addition, there is also evidence that PUFAs play a role in treating substance dependent individuals. The purpose of this study is to determine the efficacy of EFA and DPA in treating substance dependent individuals.
Participants will be randomly assigned to receive either 3 grams of n-3 PUFAs or placebo. Treatment will last 3 months, followed by an observation period of 3 months. Study visits will occur monthly and will last approximately one hour. Study visits will include blood tests and a physical exam. Throughout the study, participants will continue to receive standard substance abuse treatment and will complete urine tests at regular intervals.
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, Care Provider)
入排标准
- 年龄范围
- 25 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Current or history of drug or alcohol dependence
- •Used substances of abuse during the 3 months prior to study entry
- •Enrolled in one of the VA New York Harbor Healthcare System Brooklyn campus substance abuse clinics
排除标准
- •Current or history of hallucinations, delusions, or memory problems
- •Major physical illness (e.g., cardiovascular, pulmonary, gastrointestinal, renal, neuromuscular, or endocrine disorder)
- •Liver function test greater than one standard deviation above upper normal limit
- •Allergic to fish
研究组 & 干预措施
1
Drug Treatment
干预措施: Pro-eicosapentaenoic acid (EPA) (Drug)
1
Drug Treatment
干预措施: Pro-docosapentaenoic acid (DPA) (Drug)
2
Placebo treatment
干预措施: Placebo (Drug)