NCT01735279

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Federal University of São Paulo · Academic / Other
• Sex: All
• Age: 20 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Tobacco Dependence
• Nicotine Dependence

Interventions

Type	Name	Description
DRUG	Omega 3	Each fish oil capsule contained 210.99 mg of EPA and 129.84 mg of DHA.
DRUG	Placebo	mineral oil + food dye #2 (simulating the colour of essential fatty acids); 1000 mg of mineral oil per capsule

Timeline

• Start date: 2013-01-01
• Primary completion: 2013-12-01
• Completion: 2014-03-01
• First posted: 2012-11-28
• Last updated: 2020-10-14
• Results posted: 2020-10-14

Locations

1 site across 1 country: Brazil