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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2012 by Federal University of São Paulo.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
JGalduroz, Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01735279
First received: November 23, 2012
Last updated: November 27, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention Phase
Tobacco Dependence
Nicotine Dependence
Drug: fish oil
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: "Studying the Effects of Administration of Polyunsaturated Fatty Acids (PUFAS) of Omega-3 Series in Nicotine Dependence"

Resource links provided by NLM:


Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • Reduction on the nicotine dependence [ Time Frame: The outcomes will be accessed during the treatment (montly) ] [ Designated as safety issue: No ]
    Reduction on the nicotine dependence will be accessed by psychometric test (Fagerström Test for Nicotine Dependence) and biological measures (cotinine and carbon monoxide dosage).


Estimated Enrollment: 60
Study Start Date: January 2013
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
The omega 3 group will receive 3g per day of mineral oil during 90 days treatment
Experimental: Omega3
The omega 3 group will receive 3g per day of fish oil during 90 days treatment
Drug: fish oil

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

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01735279

Contacts
Contact: Maria Lucia O Formigoni, PhD 55 11 55492500 mlosformigoni@unifesp.br

Locations
Brazil
Unidade de Dependência de Drogas (UDED) Not yet recruiting
São Paulo, Brazil, 55
Contact: Maria Lucia O. S. Formigoni, PhD    55 11 55192500    mlosformigoni@unifesp.br   
Principal Investigator: José Carlos Fernandes Galduróz, Md PhD         
Sponsors and Collaborators
Federal University of São Paulo
Investigators
Principal Investigator: José Carlos Fernandes Galduróz, Md PhD Universidade Federal de São Paulo (UNIFESP)
  More Information

No publications provided

Responsible Party: JGalduroz, Md PhD, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT01735279     History of Changes
Other Study ID Numbers: Tobacco&Omega
Study First Received: November 23, 2012
Last Updated: November 27, 2012
Health Authority: Brazil: Ethics Committee

Keywords provided by Federal University of São Paulo:
tobacco dependence
tobacco treatment
omega 3 series
polyunsaturated fatty acids

Additional relevant MeSH terms:
Tobacco Use Disorder
Chemically-Induced Disorders
Mental Disorders
Substance-Related Disorders

ClinicalTrials.gov processed this record on November 20, 2014