Smoking during pregnancy is one of the most important modifiable causes of poor pregnancy outcomes in the United States. Unfortunately, the majority of women who smoke prior to pregnancy continue to smoke during pregnancy. Even with augmented behavioral interventions, smoking cessation rates in pregnancy trials rarely exceed 20 percent. These low quit rates may be due to inadequate treatment of the physical addiction to nicotine. Indeed, medications are first-line treatment for smoking treatment in non-pregnant smokers. However, little information is available on the safety or efficacy of medications to treat pregnant smokers. This proposal will examine the utility of one first-line medication, nicotine gum, as an aid to smoking cessation during pregnancy. The specific research aims of this project are: 1. To compare smoking cessation rates and smoking reduction among pregnant smokers who are randomized to receive 2 mg nicotine gum or a matching placebo; 2. To compare nicotine gum versus placebo on surrogate measures of maternal and fetal safety (i.e., overall nicotine and tobacco exposure), and birth weight at the time of delivery; 3. To examine which subjects benefit the most from the use of nicotine gum for smoking cessation during pregnancy. Subjects will be recruited from a prenatal clinic that serves primarily a low-income, minority population. Two hundred sixty-six pregnant smokers who smoke at least 5 cigarettes per day will be randomly assigned to receive a behavioral counseling intervention and either a 6-week course of 2 mg nicotine gum or placebo for smoking cessation followed by a 6-week taper. Primary outcome measures will be 7-day point prevalence cigarette abstinence, number of cigarettes smoked per day, saliva cotinine concentrations, and measures of tobacco exposure (i.e., carbon monoxide in exhaled air, and urine anabasine and anatabine) at 6 weeks after the quit date and at 32-34 weeks gestation. Birth weight will be obtained at the time of delivery. We hypothesize that 1. Pregnant smokers who are randomized to nicotine gum will have double the quit rates, and will reduce their smoking to a greater degree than subjects randomized to placebo; 2. Nicotine gum compared to placebo will reduce maternal cotinine levels, carboxyhemoglobin levels, and urine anabasine and anatabine levels. Birth weights will be higher in the offspring of subjects randomized to nicotine gum compared to placebo and will be negatively correlated with carbon monoxide and urinary alkaloids at 32-34 weeks gestation; 3. The odds of cigarette abstinence will be increased primarily in subjects who smoke at least 15 cigarettes per day.

Agency
National Institute of Health (NIH)
Institute
National Institute on Drug Abuse (NIDA)
Type
Research Project (R01)
Project #
3R01DA015167-03S1
Application #
7020460
Study Section
Human Development Research Subcommittee (NIDA)
Program Officer
Montoya, Ivan
Project Start
2002-07-01
Project End
2007-03-31
Budget Start
2004-04-01
Budget End
2005-03-31
Support Year
3
Fiscal Year
2005
Total Cost
$25,864
Indirect Cost
Name
University of Connecticut
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
022254226
City
Farmington
State
CT
Country
United States
Zip Code
06030
Dornelas, Ellen; Oncken, Cheryl; Greene, John et al. (2013) Major depression and PTSD in pregnant smokers enrolled in nicotine gum treatment trial. Am J Addict 22:54-9
Oncken, Cheryl (2012) Nicotine replacement for smoking cessation during pregnancy. N Engl J Med 366:846-7
Oncken, Cheryl; Campbell, Winston; Chan, Grace et al. (2009) Effects of nicotine patch or nasal spray on nicotine and cotinine concentrations in pregnant smokers. J Matern Fetal Neonatal Med 22:751-8
Oncken, Cheryl A; Kranzler, H R (2009) What do we know about the role of pharmacotherapy for smoking cessation before or during pregnancy? Nicotine Tob Res 11:1265-73
Oncken, Cheryl; Dornelas, Ellen; Greene, John et al. (2008) Nicotine gum for pregnant smokers: a randomized controlled trial. Obstet Gynecol 112:859-67
Hussain, Naveed; Krueger, Winfried; Covault, Jonathan et al. (2008) Effects of prenatal tobacco exposure on gene expression profiling in umbilical cord tissue. Pediatr Res 64:147-53
Hatsukami, Dorothy K; Benowitz, Neal L; Rennard, Stephen I et al. (2006) Biomarkers to assess the utility of potential reduced exposure tobacco products. Nicotine Tob Res 8:169-91
Oncken, Cheryl; Prestwood, Karen; Kleppinger, Alison et al. (2006) Impact of smoking cessation on bone mineral density in postmenopausal women. J Womens Health (Larchmt) 15:1141-50
Oncken, Cheryl; McKee, Sherry; Krishnan-Sarin, Suchitra et al. (2005) Knowledge and perceived risk of smoking-related conditions: a survey of cigarette smokers. Prev Med 40:779-84
Oncken, Cheryl; McKee, Sherry; Krishnan-Sarin, Suchitra et al. (2004) Gender effects of reported in utero tobacco exposure on smoking initiation, progression and nicotine dependence in adult offspring. Nicotine Tob Res 6:829-33

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