Fish Oil to Reduce Tobacco Use iN Expectant Mothers Study

• Status: Completed
• Trial end date: 2018-09-05
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Vanderbilt University Medical Center

Criteria

Inclusion Criteria:

• ≥ 18 or ≤ 45 years of age

• Currently reporting daily cigarette use (≥ 1 CPD, no averages, must have daily use)

• Between 6 and 36 weeks gestation

Exclusion Criteria:

• Allergy to fish or seafood

• Currently using fish oil supplements and unwilling to stop prior to and during the trial

• Unstable psychiatric disease: Defined as requiring hospitalization or active medication changes (medication changes or up titration) within the preceding 3 months

• Unstable pregnancy-related medical problems (pre-eclampsia, premature labor, threatened abortion, oligohydramnios, placenta previa, hyperemesis gravidarum, HELLP syndrome, Intrauterine growth restriction, cholestasis of pregnancy, Rh negative disease, gestational hypertension, placenta accreta)