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

NCT01735279 | Completed Phase 3 Results

• 1 other identifier: Tobacco&Omega
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Tobacco Dependence; Nicotine Dependence

Keywords

tobacco dependence; tobacco treatment; omega 3 series; polyunsaturated fatty acids

Outcome Measures

Primary Outcomes (1)

• Fageström Test for Nicotine Dependence Score at Baseline 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.

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

Secondary Outcomes (2)

• 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

• Concentration of Eicosapentaenoic Acid (EPA)

  At baseline (prior to the beginning of the treatment) and after 90 days of treatment

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Omega3

EXPERIMENTAL

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

Drug: Omega 3

Interventions

Omega 3 DRUG

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

Also known as: fish oil, omega 3 fatty acid

Omega3

Placebo DRUG

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

Also known as: mineral oil

Placebo

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Federal University of São Paulo: lead

Study Sites (1)

Unidade de Dependência de Drogas (UDED)

São Paulo, 55, Brazil

Location

MeSH Terms

Conditions

Tobacco Use Disorder

Interventions

Docosahexaenoic Acids; Fish Oils; Fatty Acids, Omega-3; Mineral Oil

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Oils; Petrolatum; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Md PhD José Carlos F. Galduróz
• Organization: Department of Psychobiology, Universidade Federal de São Paulo (UNIFESP), Rua Napoleão de Barros, São Paulo , Brazil

galduroz@unifesp.br

+55 11 2149 0000

Study Officials

• José Carlos F. Galduróz, Md PhD

  Universidade Federal de São Paulo (UNIFESP)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Md PhD

Study Record Dates

• First Submitted: November 23, 2012
• First Posted: November 28, 2012
• Study Start: January 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: March 1, 2014
• Last Updated: October 14, 2020
• Results First Posted: October 14, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)