Nicotine Replacement Treatment for Pregnant Smokers - 1

• Status: Terminated
• Trial end date: 2007-04-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute on Drug Abuse (NIDA)
• Treatments: Nicotine

Criteria

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