Fish Oil to Reduce Tobacco Use iN Expectant Mothers Study

Completed · Phase 2 · Has a placebo group

Conditions studied: Tobacco Use in Childbirth, Smoking Cessation, Pregnancy Related

In brief

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.

Key facts

Study ID

NCT03077724

Run by

Vanderbilt University Medical Center

People needed

28

Starts

2017-03-02

Expected to finish

2018-09-05

Last updated by the study team

2019-01-09

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• ≥ 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

You may not qualify if…

• 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)

Where it is running

• Vanderbilt University Medical Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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