Studying the Effects of Administration of Polyunsaturated Fatty Acids (PUFAS) of Omega-3 Series in Nicotine Dependence
Condition: Tobacco Dependence; Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Omega 3; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Each fish oil capsule contained 210.99 mg of EPA and 129.84 mg of DHA.; mineral oil + food dye #2 (simulating the colour of essential fatty acids); 1000 mg of mineral oil per capsule
Other intervention name(s): fish oil; omega 3 fatty acid; mineral oil
Intervention MeSH terms: Mineral Oil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: tobacco dependence; tobacco treatment; omega 3 series; polyunsaturated fatty acids