Phase 2
N=28
Fish Oil to Reduce Tobacco Use iN Expectant Mothers Study
Tobacco Use in Childbirth · Smoking Cessation · Pregnancy Related
Bottom Line
View on ClinicalTrials.gov: NCT03077724 ↗Enrolled (actual)
28
Serious AEs
3.6%
Results posted
Jan 2019
Primary outcome: Primary: Change in Cigarettes Per Day From Baseline to 4-weeks — -0.94; 0 Cigarettes smoked per day
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Fish oil (Drug); Placebos (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Vanderbilt University Medical Center
- Primary completion
- Jan 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Cigarettes Per Day From Baseline to 4-weeks |
-0.94; 0 | — |
| SECONDARY Change in Fagerström Scores From Baseline to 4-weeks |
-1; 0 | — |
| SECONDARY Point Prevalence Abstinence |
0; 1 | — |
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.
Eligibility 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)
Data sourced from ClinicalTrials.gov (NCT03077724). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.