Fish Oil to Reduce Tobacco Use iN Expectant Mothers Study

The goals of that submission will be to conduct a clinical trial of n-3 long-chain polyunsaturated fatty acids (LCPUFAs) for smoking cessation in pregnant women, who are at very high risk of continued smoking because pregnant generally cannot use any of the FDA-approved smoking cessation medications. Recently, two small scale, double-blind, randomized control trials have found that supplementation with n-3 LCPUFA reduces signs of nicotine dependence. While promising, these studies were not conducted in pregnancy, leaving an important gap in the scientific literature for this vulnerable group of smokers. For this proposal, the investigators will develop, test, and refine the recruitment strategy, and collect data demonstrating the 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 will gather preliminary effect size data on smoking behavior to allow more formal estimated of sample size for a larger, more definitive trial. The investigators hypothesize that pregnant smokers randomized to n-3 LCPUFA supplementation will smoke fewer cigarettes per day compared to women allocated to placebo. In secondary analyses the investigators will compare self-reported nicotine cravings and 7-day point-prevalence smoking abstinence (assessed at 30 days) between n-3 LCPUFA and placebo groups. The investigators intend to use this preliminary data to inform a future randomized, double-blind, placebo-controlled trial of n-3 LCPUFA supplementation for long-term tobacco cessation in pregnancy.

The specific aims are:

SA1: To successfully recruit and randomize 40 pregnant, current smokers into a clinical trial of n-3 LCPUFA supplementation.

SA2: To assess the tolerability of 4 gm/day n-3 LCPUFA supplementation in pregnant, current smokers over a 4-week period SA3: To determine the effect of 4 grams/day n-3 LCPUFA supplementation for 4-weeks on cigarettes smoked per day and self-reported nicotine cravings in pregnant smokers

Research Design and Methods This study is a randomized, double-blind, placebo controlled study of 4 grams/day n-3 LCPUFA supplementation versus placebo for 4-weeks. The study will recruit pregnant women in the second trimester who are currently smoking. The primary outcomes will include changes from baseline in cigarettes per day. The secondary outcome will be self-reported nicotine cravings, and point prevalence abstinence at 30 days. The investigators will also collect safety and tolerability data.