Nicotine Gum for Pregnant Smokers: A Randomized Controlled Trial
Open accessAbstract
OBJECTIVE: To estimate the safety and efficacy of treatment with 2-mg nicotine gum for smoking cessation during pregnancy. METHODS: Pregnant women who smoked daily received individualized behavioral counseling and random assignment to a 6-week treatment with 2-mg nicotine gum or placebo followed by a 6-week taper period. Women who did not quit smoking were instructed to reduce the number of cigarettes smoked by substituting with gum. Measures of tobacco exposure were obtained throughout the study. RESULTS: Participants in the nicotine (n = 100) and placebo (n = 94) groups were comparable in age, race/ethnicity, and smoking history. Biochemically validated smoking-cessation rates were not significantly higher with nicotine gum compared with placebo (after 6 weeks of treatment: 13% compared with 9.6%, P=.45; at 32-34 weeks of gestation: 18% compared with 14.9%, P=.56). Using a completer analysis, nicotine gum significantly reduced the number of cigarettes smoked per day (nicotine gum: -5.7 [standard deviation (SD)=6.0]; placebo: -3.5 [SD=5.7], P=.035), and cotinine concentration (nicotine gum: -249 ng/mL [SD=397]; placebo: -112 ng/mL [SD=333]; P=.04). Birth weights were significantly greater with nicotine gum compared with placebo (3,287 g [SD=566] and 2,950 g [SD=653], respectively, P<.001). Gestational age was also greater with nicotine-replacement therapy than with placebo (38.9 weeks [SD=1.7] and 38.0 weeks [SD=3.3], respectively; P=.014). CONCLUSION: Although nicotine gum did not increase quit rates, use of nicotine gum increased birth weight and gestational age, two key parameters in predicting neonatal wellbeing.
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Four placebo-RCTs were judged at low risk of bias, two non-placebo RCTs at high risk, and one study unclear.
“Four placebo-RCTs were judged to be at low [23,24,26,29] and two non-placebo RCTs at high risk of bias [25,28]; for the remaining study this was unclear [27].”
From Fetal safety of nicotine replacement therapy in pregnancy: systematic review and meta-analysis. (2021) · cites this paper as [26]
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- Authors
- Oncken, C., Dornelas, E., Greene, J., Sankey, H., Glasmann, A., Feinn, R., & Kranzler, H. R.
- Affiliations
- University of Connecticut (US)
- Hartford Hospital (US)
- Baystate Medical Center (US)
- Yale University (US)
- Venue
- Obstetrics & Gynecology
- Published
- 2008-10
- Volume
- 112
- Issue
- 4
- Pages
- 859-867
- ISSN
- 0029-7844 (ISSN-L)
- PMC
- PMC2630492
- OpenAlex
- W2135464095
- Cited by
- 114
- References
- 31
- Citations by year
- 2026: 1 · 2025: 1 · 2023: 1 · 2022: 2 · 2021: 4 · 2020: 7 · 2019: 7 · 2018: 7 · 2017: 8 · 2016: 6 · 2015: 7 · 2014: 14 · 2013: 5 · 2012: 10
- FWCI
- 7.70
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Obstetrics and Gynecology (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- Funders
- National Institute on Alcohol Abuse and Alcoholism (K24 AA13736, P50AA015632, K24AA013736)
- National Institute on Drug Abuse (R01DA015167, R01-DA15167, P50DA013334)
- National Center for Research Resources (M01RR006192)
- Topics
- Health Sciences › Medicine › Physiology › Smoking Behavior and Cessation
- Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Prenatal Substance Exposure Effects
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Pregnancy and Medication Impact
- Keywords
- nicotine gum, smoking cessation, pregnancy, nicotine replacement therapy, birth weight, gestational age, cotinine, tobacco smoke exposure, behavioral counseling
- MeSH terms
- Birth Weight, Chewing Gum, Cotinine, Counseling, Double-Blind Method, Female, Humans, Nicotine, Pregnancy, Pregnancy Outcome, Prospective Studies, Smoking Cessation, Nicotinic Agonists
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