Phase 3
N=58
Studying the Effects of Administration of Polyunsaturated Fatty Acids (PUFAS) of Omega-3 Series in Nicotine Dependence
Tobacco Dependence · Nicotine Dependence
Bottom Line
View on ClinicalTrials.gov: NCT01735279 ↗Enrolled (actual)
58
Serious AEs
0.0%
Results posted
Oct 2020
Primary outcome: Primary: Fageström Test for Nicotine Dependence Score at Baseline and After 90 Days of the Treatment — 6.53; 6.56; 5.96; 5.22 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Omega 3 (Drug); Placebo (Drug)
- Age
- Adult · 20+ yrs
- Sex
- All
- Sponsor
- Federal University of São Paulo
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Fageström Test for Nicotine Dependence Score at Baseline and After 90 Days of the Treatment |
6.53; 6.56; 5.96; 5.22 | — |
| SECONDARY Concentration of Docosahexaenoic Acid (DHA) at Baseline and After 90 Days of Treatment |
747.71; 645.38; 663.93; 1,004.94 | — |
| SECONDARY Concentration of Eicosapentaenoic Acid (EPA) |
77.00; 86.76; 77.39; 174.87 | — |
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.
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;
Data sourced from ClinicalTrials.gov (NCT01735279). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.