Placebo-controlled Trial of Bupropion for Smoking Cessation in Pregnant Women
Status:
Completed
Trial end date:
2020-01-22
Target enrollment:
Participant gender:
Summary
Smoking during pregnancy adversely affects the health of the mother and her developing baby.
Maternal smoking approximately doubles the risk of miscarriage, placental complications,
preterm delivery, low birth weight and fetal and newborn death. The most common adverse
effect of smoking during pregnancy is low birth weight, which sharply increases the risk of
the newborn becoming ill or dying. In the US, maternal smoking is responsible for 30% of low
birth weight babies, 10% of premature deliveries, and 5% of infant deaths. Fortunately,
smoking cessation by pregnancy week 16, or as late as the third trimester, results in a
near-normal weight infant at birth. Even reductions in smoking increase birth weight.
Despite the known risks, the majority of women who are smoking at the time of their first
prenatal visit continue to smoke. Bupropion is approved by the US Food and Drug
Administration (FDA) for smoking cessation in people who are not pregnant, but there are no
carefully controlled studies on the use of Bupropion to help pregnant women quit smoking.
Bupropion is also FDA approved to treat depression, and some pregnant women have taken it for
that purpose, even though it has not been formally tested. The investigators propose to
conduct a randomized, parallel-group, double-blinded, placebo-controlled, 10 week trial of
Bupropion in 360 pregnant women who smoke daily and wish to quit smoking.
The study has three primary hypotheses. First, the investigators hypothesize that Bupropion
treated subjects will decrease the frequency of smoking more than placebo-treated subjects.
Second the investigators hypothesize that Bupropion treated subjects will have greater
positive pregnancy and child health outcomes than placebo-treated subjects. Third the
investigators hypothesize that Bupropion treated subjects will have decreased frequency of
depressive symptoms and cigarette craving than placebo-treated subjects. These finding will
provide information on the safety and efficacy of bupropion treat for smoking cessation in
pregnant women.