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临床试验/NCT01735279
NCT01735279已完成3 期

"Studying the Effects of Administration of Polyunsaturated Fatty Acids (PUFAS) of Omega-3 Series in Nicotine Dependence"

Federal University of São Paulo1 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2013年1月最近更新:
适应症
干预措施

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
58
试验地点
1
主要终点
Fageström Test for Nicotine Dependence Score at Baseline and After 90 Days of the Treatment

研究概览

简要总结

Nicotine dependence may prolong the exposure to toxic substances that cause various diseases. The Central Nervous System (CNS) is consisted by a large amount of Polyunsaturated Fatty Acids (PUFAS) from omega-3 serie. Omega-3 takes part in several actions, including the modulation of dopaminergic neurotransmission. In its deficiency is detected a hypofunctioning of the mesolimbic and mesocortical pathway, related to the reward system, involved on the context of nicotine dependence. Treatment using dietary supplementation with omega-3 shows improvements in several diseases, including mood disorders such as anxiety and depression. The investigators hypothesis is that supplementation with these fatty acids can restore the levels of omega-3 and could decrease nicotine dependence. The investigators objective is to investigate a possible association between increased serum levels of omega-3 and the reduction in nicotine dependence.

详细描述

Introduction

A cigarette has more than 6,000 toxic substances that can cause various diseases. Nicotine dependence may prolong the exposure to these toxic substances. The Central Nervous System (CNS) is consisted by a large amount of Polyunsaturated Fatty Acids (PUFAS) from omega-3 serie. Omega-3 takes part in several actions, including the modulation of dopaminergic neurotransmission. In its deficiency is detected a hypofunctioning of the mesolimbic and mesocortical pathway, related to the reward system, involved on the context of nicotine dependence. Treatment using dietary supplementation with omega-3 shows improvements in several diseases, including mood disorders such as anxiety and depression. The investigators hypothesis is that supplementation with these fatty acids can restore the levels of omega-3 and could decrease nicotine dependence. Objective: Investigate a possible association between increased serum levels of omega-3 and the reduction in nicotine dependence. Material and Methods: In the clinical study, placebo controlled, double-blind, parallel, randomized, will be administered to 60 volunteers: placebo or fish oil for 90 days. Psychometric assessments will be carried out, measurements of serum levels of PUFAS, levels of carbon monoxide (CO) and cotinine in plasma will be done for monitoring the clinical course. Data Analysis: Repeated measures (ANOVA) for the dependent variables (dependency, anxiety, depression, motivation, compulsion, dosage of PUFAS, exhaled CO and cotinine) and independent (groups and time) to check for significant differences. If so, a second ANOVA with covariates will be conducted. Significance is p <0.05 in all analyzes.

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
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • healthy smokers; age between 20 and 60 years; score in Fagerström Test for Nicotine Dependence (FTND) up to 5 points (FTND > 5); high motivation to stop smoking (accessed by Richmond Test)

排除标准

  • psychiatric disorders; taking psychoactive medications; history of alcohol and/or other drugs abuse or dependence;

研究组 & 干预措施

Placebo

Placebo Comparator

The placebo group will receive 3g per day of mineral oil during 90 days treatment

干预措施: Placebo (Drug)

Omega3

Experimental

The omega 3 group will receive 3g per day of fish oil during 90 days treatment

干预措施: Omega 3 (Drug)

结局指标

主要结局

Fageström Test for Nicotine Dependence Score at Baseline and After 90 Days of the Treatment

时间窗: Baseline (prior to the beginning) and after 90 days of the treatment

The Fageström Test for Nicotine Dependence is a widely used test to measure the nicotine dependence. This test was chosen to evaluate the possible changes on the nicotine dependence during the clinical trial. The range for the scale is: very low (dependence) 0-2 low (dependence) 3-4 moderate (dependence) 5 high (dependence) 6-7 very high (dependence) 8-10 So, lower levels (low scores on the scale) of the FTND measure indicates lower nicotine dependence, and higher levels (high scores on the scales) of the FTND measure indicates higher nicotine dependence.

次要结局

  • Concentration of Eicosapentaenoic Acid (EPA)(At baseline (prior to the beginning of the treatment) and after 90 days of treatment)
  • Concentration of Docosahexaenoic Acid (DHA) at Baseline and After 90 Days of Treatment(At baseline (prior to the beginning of the treatment) and after 90 days of treatment)

研究者

发起方
Federal University of São Paulo
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jose Carlos Fernandes Galduroz MD

Md PhD

Federal University of São Paulo

研究点 (1)

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