CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 58 enrolled
Drug / intervention
Omega 3 +1 moredrug
Likely dose
Omega 3 210.99 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01735279
NCT01735279Phase 3Completed

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

Federal University of São Paulo·interventional·Posted Nov 28, 2012·Updated Oct 14, 2020

In Brief

A Phase 3 clinical trial evaluating Omega 3 and Placebo for Tobacco Dependence and Nicotine Dependence. Completed, enrolled 58 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBrazil
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedNov 28, 2012
Enrollment StartJan 1, 2013
Primary CompletionDec 1, 2013
Study CompletionMar 1, 2014
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 13.6 years ago

Interventions

Omega 3drug

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

Placebodrug

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