Nicotine Replacement Treatment for Pregnant Smokers - 1
Status:
Terminated
Trial end date:
2007-04-01
Target enrollment:
Participant gender:
Summary
Smoking during pregnancy is an important modifiable cause of poor pregnancy outcomes. Even
with augmented behavioral interventions, smoking cessation rates in pregnancy trials rarely
exceed 20%. These low quit rates may be due to inadequate treatment of the physical
dependence on nicotine. Indeed, medications, which may help to reduce nicotine withdrawal
symptoms, are a 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.
The purpose of this trial is to evaluate the safety and effectiveness of 2 mg nicotine gum in
promoting smoking cessation during pregnancy. The design is a randomized, placebo controlled
trial where subjects are randomized to nicotine gum (6 weeks ad libitum use followed by a 6
week taper) or a matching placebo. Women who are doing well at the end of the trial will also
be offered gum post-partum for relapse prevention.