At a glance
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Fish Oil to Reduce Tobacco Use iN Expectant Mothers Study
In Brief
A Phase 2 clinical trial evaluating Fish oil and Placebos for Tobacco Use in Childbirth and 2 related conditions. Completed, enrolled 28 participants across 1 site.
Detailed Summary
The purpose of this feasibility study is to obtain pilot data in preparation for an upcoming R01 submission. The goals of that submission will be to conduct a clinical trial of n-3 LCPUFAs for smoking cessation in pregnant women. For this proposal, the investigators will develop, test, and refine the recruitment strategy and collect data demonstrating the investigators ability to successfully recruit pregnant women who are actively smoking. The investigators will collect side effect, tolerability, and adherence data regarding the intervention. Finally, the investigators hope to gather preliminary effect size data to allow more formal estimates of sample size. The investigators hypothesize that pregnant smokers randomized to n-3 LCPUFA supplementation will have higher smoking cessation rates and less nicotine cravings compared to women allocated to placebo. The investigators intend to use this preliminary data to inform a future randomized, double-blind, placebo-controlled trial of n-3 LCPUFA supplementation for tobacco cessation.
Study Details
Timeline
Interventions
Fish oil supplementation
Olive Oil capsules