Smoking Cessation Clinical Trial
— FORTUNEOfficial title:
Fish Oil to Reduce Tobacco Use iN Expectant Mothers Study
Verified date | December 2018 |
Source | Vanderbilt University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 28 |
Est. completion date | September 5, 2018 |
Est. primary completion date | January 23, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility |
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) |
Country | Name | City | State |
---|---|---|---|
United States | Vanderbilt University Medical Center | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Vanderbilt University Medical Center |
United States,
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. — View Citation
Zaparoli JX, Sugawara EK, de Souza AA, Tufik S, Galduróz 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Change in Fagerström Scores From Baseline to 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. | 4 weeks | |
Secondary | Point Prevalence Abstinence | Point prevalence abstinence at 4 weeks biochemically confirmed by end-expired carbon monoxide | 4 weeks |
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