Fish Oil to Reduce Tobacco Use iN Expectant Mothers Study

ClinicalTrials.gov ID: NCT03077724

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Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID: NCT03077724
Recruitment status: Completed
Study type: Interventional
Phase: Phase 2
Lead sponsor: Vanderbilt University Medical Center; Other
Enrollment: 28 participants

Conditions and interventions

Conditions

Interventions

Fish oil Drug
Placebos Drug

Drug

Eligibility (public fields only)

Age range: 18 Years to 45 Years
Sex: Female
Healthy volunteers: Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Mar 2, 2017 (Actual)
Primary completion: Jan 23, 2018 (Actual)
Completion: Sep 5, 2018 (Actual)
Last update posted: Jan 9, 2019

2017 – 2018

United States locations

U.S. sites: 1
U.S. states: 1
U.S. cities: 1

Facility	City	State	ZIP	Site status
Vanderbilt University Medical Center	Nashville	Tennessee	37232	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT03077724, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Jan 9, 2019 · Synced Nov 15, 2026