Nicotine Replacement Treatment for Pregnant Smokers - 1

This proposal will examine the utility of one first-line medication, nicotine gum, as an aid
to smoking cessation during pregnancy.

The specific aims are:

- (1) To compare smoking cessation rates and smoking reduction among pregnant smokers who
are randomized to receive nicotine gum (2 mg dose) 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 at 6 weeks after the quit date and
at 32-34 weeks gestation) 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 prenatal clinics that serve primarily a low-income, minority
population. Two hundred sixty-eight pregnant smokers will be randomly assigned to receive
smoking cessation behavioral counseling and either a 6-week course of mint flavored placebo
or nicotine gum, followed by 6 weeks of decreasing doses. Maternal blood for genotyping will
be obtained at study entry. Primary outcome measures will be 7-day point prevalence of
cigarette abstinence, number of cigarettes smoked per day, urinary 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, and infant birth
weight. 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 levels of tobacco-exposure
markers and increase birth weights in the offspring;

- (3) The odds of cigarette abstinence will be increased primarily in subjects who smoke
at least 15 cigarettes per day.

Inclusion Criteria:

- Patient's gestational age is 26 weeks or less.

- Patient is at least 16 years of age.

- Patient is able to speak English or Spanish.

- Patient intends to carry to term.

- Patient has stable residence.

- Patient has smoked five or more cigarettes everyday for the past seven days.

Exclusion Criteria:

- Evidence that the patient is pregnant with a fetus with a known congenital
abnormality.

- Unstable medical problems (i.e., hyperthyroidism, temporomandibular joint disorder,
pre-eclampsia, threatened abortion, hyperemesis gravidarum)

- Multiple Gestation

- Unstable psychiatric disorder

- Current drug or alcohol abuse or dependence