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

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ClinicalTrials.gov Identifier: NCT03077724
Recruitment Status : Recruiting
First Posted : March 13, 2017
Last Update Posted : January 25, 2018
Sponsor:
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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 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
Estimated Study Completion Date : June 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. Cigarettes per day [ Time Frame: 4 weeks ]
    Reduction in total number of cigarettes per day from baseline to 4-weeks


Secondary Outcome Measures :
  1. Fagerström Tolerance Questionnaire [ Time Frame: 4 weeks ]
    Reduction in the Fagerström Tolerance Questionnaire from baseline to 4-weeks

  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
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)

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 ClinicalTrials.gov identifier (NCT number): NCT03077724


Contacts
Contact: Harvey J Murff, MD, MPH 615 936 8270 fortunestudy@vanderbilt.edu

Locations
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Harvey J Murff, MD, MPH    615-936-8319    harvey.j.murff@vanderbilt.edu   
Principal Investigator: Harvey J Murff, MD, MPH         
Sub-Investigator: Hilary A Tindle, MD, MPD         
Sub-Investigator: Matthew S Freiberg, MD, MSc         
Sub-Investigator: Katherine E Hartmann, MD, PhD         
Sub-Investigator: Rosette J Chakkalakal, MD, MPH         
Sub-Investigator: Qiuyin Cai, PhD         
Sub-Investigator: Robert A Greevy, PhD         
Sponsors and Collaborators
Vanderbilt University Medical Center
Investigators
Principal Investigator: Harvey J Murff, MD, MPH Vanderbilt University Medical Center

Publications:
Responsible Party: Harvey Murff, Associate Professor, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT03077724     History of Changes
Other Study ID Numbers: 161820
First Posted: March 13, 2017    Key Record Dates
Last Update Posted: January 25, 2018
Last Verified: January 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

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
pregnancy