Docosahexaenoic Acid (DHA) Effects on Cognitive Function, Craving and Psychosocial Factors in Heavy Cigarette Smokers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Reduction in smoking urges and craving
研究概览
简要总结
The purpose of this study is to assess effects of Docosahexaenoic Acid (DHA) as an add-on novel supplement on quality of life, cognitive function, craving and psychosocial factors in heavy cigarette smokers. In humans, no previous randomized, double blind controlled study has been conducted to evaluate these effects. The aim of the study is to 1. Test Docosahexaenoic Acid (DHA) beneficial effects on objective clinical indicators of cognitive function (choice reaction time, decision making, impulsivity, facial recognition) in smokers 2. Improvement of quality of life, cigarette craving, psychosocial factors and self-perceptions in smokers treated with DHA supplement
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Nicotine dependence
- •Smoked at least 10 cigarettes per day for the past 12 months and not interested in quitting
排除标准
- •Serious kidney, lun, neurological and cardiovascular diseases
- •Suicide risk, acute psychosis, severe depression, organic brain syndromes
- •Dependence on psychoactive substances other than nicotine
研究组 & 干预措施
I. DHA
Oral ingestion 5 tablets DHA + EPA (daily ingestion DHA 2040 mg and EPA 2710 mg)- (Omega 3 - 950,the Solgar Pharmaceutical Co., Israel).
干预措施: DHA (Dietary Supplement)
II. Placebo
Oral ingestion of 5 tablets containing the following: gelatin,glycerine,water and soy oil made by the Solgar Pharmaceutical Co., Israel
干预措施: Oral ingestion of 5 placebo tablets (Dietary Supplement)
结局指标
主要结局
Reduction in smoking urges and craving
时间窗: One and a half years
Reduction in smoking urges and craving to be measured by the following: smoking urges and craving scales; choice reaction time, impulsivity computerized test, quality of life questionnaire, depression inventory, general health questionnaire, scale of perceived social support, facial expression task, self-esteem diary
次要结局
未报告次要终点