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

NCT ID: NCT01735279

Last Updated: 2020-10-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2014-03-31

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.

Conditions

Tobacco Dependence; Nicotine Dependence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

mineral oil + food dye #2 (simulating the colour of essential fatty acids); 1000 mg of mineral oil per capsule

Omega3

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

Group Type: EXPERIMENTAL

Omega 3

Intervention Type: DRUG

Each fish oil capsule contained 210.99 mg of EPA and 129.84 mg of DHA.

Interventions

Omega 3

Each fish oil capsule contained 210.99 mg of EPA and 129.84 mg of DHA.

Intervention Type: DRUG

Placebo

mineral oil + food dye #2 (simulating the colour of essential fatty acids); 1000 mg of mineral oil per capsule

Intervention Type: DRUG

Other Intervention Names

fish oil; omega 3 fatty acid; mineral oil

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;

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Federal University of São Paulo

OTHER

Sponsor Role: lead

Responsible Party

Jose Carlos Fernandes Galduroz MD

Md PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

José Carlos F. Galduróz, Md PhD

Role: PRINCIPAL_INVESTIGATOR

Universidade Federal de São Paulo (UNIFESP)

Locations

Unidade de Dependência de Drogas (UDED)

São Paulo, , Brazil

Countries

Brazil

Other Identifiers

Tobacco&Omega

Identifier Type: -

Identifier Source: org_study_id