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Fish Oil to Reduce Tobacco Use iN Expectant Mothers Study (FORTUNE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03077724
Recruitment Status : Completed
First Posted : March 13, 2017
Results First Posted : January 9, 2019
Last Update Posted : January 9, 2019
Information provided by (Responsible Party):
Harvey Murff, Vanderbilt University Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Tobacco Use in Childbirth Smoking Cessation Pregnancy Related Drug: Fish oil Drug: Placebos Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, double-blinded, placebo controlled trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double-blind, placebo control with medications dispensed by the Investigational Drug Service
Primary Purpose: Treatment
Official Title: Fish Oil to Reduce Tobacco Use iN Expectant Mothers Study
Actual Study Start Date : March 2, 2017
Actual Primary Completion Date : January 23, 2018
Actual Study Completion Date : September 5, 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Fish Oil
4.2 grams per day of n-3 long chain polyunsaturated fatty acids (LCPUFA)
Drug: Fish oil
Fish oil supplementation
Other Name: n-3 LCPUFAs

Placebo Comparator: Placebos
Olive oil supplements
Drug: Placebos
Olive Oil capsules
Other Name: Olive Oil

Primary Outcome Measures :
  1. Change in Cigarettes Per Day From Baseline to 4-weeks [ Time Frame: 4 weeks ]
    Change in total number of cigarettes per day from baseline to 4-weeks

Secondary Outcome Measures :
  1. Change in Fagerström Scores From Baseline to 4-weeks [ Time Frame: 4 weeks ]
    Change in the Fagerström Test for Nicotine Dependency Score from baseline to 4-weeks. This scale is a validated instrument that measures nicotine dependency. The Fagerström Test for Nicotine Dependency is a 6-time survey. Each item is scores with a minimal score of 0 and a maximal score of 10. Higher scores indicate a higher level of nicotine dependency.

  2. Point Prevalence Abstinence [ Time Frame: 4 weeks ]
    Point prevalence abstinence at 4 weeks biochemically confirmed by end-expired carbon monoxide

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Eligibility requirements requires participant to be pregnant
Accepts Healthy Volunteers:   Yes

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03077724

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United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University Medical Center
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Principal Investigator: Harvey J Murff, MD, MPH Vanderbilt University Medical Center
  Study Documents (Full-Text)

Documents provided by Harvey Murff, Vanderbilt University Medical Center:

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Responsible Party: Harvey Murff, Associate Professor, Vanderbilt University Medical Center Identifier: NCT03077724     History of Changes
Other Study ID Numbers: 161820
First Posted: March 13, 2017    Key Record Dates
Results First Posted: January 9, 2019
Last Update Posted: January 9, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: This is a pilot and feasibility trial. We are not planning to share IPD with other researchers

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Harvey Murff, Vanderbilt University Medical Center:
n-3 polyunsaturated fatty acids
tobacco use