Fish Oil to Reduce Tobacco Use iN Expectant Mothers Study

NCT03077724 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 161820
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Tobacco Use in Childbirth; Smoking Cessation; Pregnancy Related

Keywords

n-3 polyunsaturated fatty acids; tobacco use; pregnancy

Outcome Measures

Primary Outcomes (1)

• Change in Cigarettes Per Day From Baseline to 4-weeks

  Change in total number of cigarettes per day from baseline to 4-weeks

  4 weeks

Secondary Outcomes (2)

• Change in Fagerström Scores From Baseline to 4-weeks

  4 weeks

• Point Prevalence Abstinence

  4 weeks

Study Arms (2)

Fish Oil

EXPERIMENTAL

4.2 grams per day of n-3 long chain polyunsaturated fatty acids (LCPUFA)

Drug: Fish oil

Placebos

PLACEBO COMPARATOR

Olive oil supplements

Drug: Placebos

Interventions

Fish oil DRUG

Fish oil supplementation

Also known as: n-3 LCPUFAs

Fish Oil

Placebos DRUG

Olive Oil capsules

Also known as: Olive Oil

Placebos

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Eligibility requirements requires participant to be pregnant
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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)

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (2)

• Rabinovitz S. Effects of omega-3 fatty acids on tobacco craving in cigarette smokers: A double-blind, randomized, placebo-controlled pilot study. J Psychopharmacol. 2014 Aug;28(8):804-9. doi: 10.1177/0269881114536477. Epub 2014 Jun 4.

  PMID: 24899596 BACKGROUND

• Zaparoli JX, Sugawara EK, de Souza AA, Tufik S, Galduroz JC. Omega-3 Levels and Nicotine Dependence: A Cross-Sectional Study and Clinical Trial. Eur Addict Res. 2016;22(3):153-62. doi: 10.1159/000439525. Epub 2015 Nov 17.

  PMID: 26570994 BACKGROUND

MeSH Terms

Conditions

Smoking Cessation; Tobacco Use

Interventions

Fish Oils; Olive Oil

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Oils; Lipids; Dietary Fats, Unsaturated; Dietary Fats; Fats; Fats, Unsaturated; Plant Oils; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Limitations and Caveats

This was a feasibility study and the overall number of subjects was small. There was significant lost to follow up

Results Point of Contact

• Title: Harvey J Murff
• Organization: Vanderbilt University Medical Center

harvey.j.murff@vanderbilt.edu

615 936 8319

Study Officials

• Harvey J Murff, MD, MPH

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind, placebo control with medications dispensed by the Investigational Drug Service
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Randomized, double-blinded, placebo controlled trial

Study Record Dates

• First Submitted: March 3, 2017
• First Posted: March 13, 2017
• Study Start: March 2, 2017
• Primary Completion: January 23, 2018
• Study Completion: September 5, 2018
• Last Updated: January 9, 2019
• Results First Posted: January 9, 2019

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)