Clinical trial NCT01735279: Studying the Effects of Administration of Polyunsaturated Fatty Acids (PUFAS) of Omega-3 Series in Nicotine Dependence
Official title: "Studying the Effects of Administration of Polyunsaturated Fatty Acids (PUFAS) of Omega-3 Series in Nicotine Dependence"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Tobacco Dependence
Nicotine Dependence
Keywords: tobacco dependence
tobacco treatment
omega 3 series
polyunsaturated fatty acids
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2012-11-28
Enrollment: 58
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

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

Primary outcomes:
measure: Fageström Test for Nicotine Dependence Score at Baseline and After 90 Days of the Treatment
timeFrame: Baseline (prior to the beginning) and after 90 days of the treatment
Secondary outcomes:
measure: Concentration of Docosahexaenoic Acid (DHA) at Baseline and After 90 Days of Treatment
timeFrame: At baseline (prior to the beginning of the treatment) and after 90 days of treatment
measure: Concentration of Eicosapentaenoic Acid (EPA)
timeFrame: At baseline (prior to the beginning of the treatment) and after 90 days of treatment
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Unidade de Dependência de Drogas (UDED)
Study officials:
affiliation: Universidade Federal de São Paulo (UNIFESP)
name: José Carlos F. Galduróz, Md PhD
role: PRINCIPAL_INVESTIGATOR
References: