NCT01656733

Nicotine Replacement for Smoking Cessation During Pregnancy

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 154 (actual)
• Sponsor: UConn Health · Academic / Other
• Sex: Female
• Age: 16 Years
• Healthy volunteers: Accepted

Summary

This is a clinical trial to determine if the nicotine inhaler in combination with counseling will help pregnant women quit smoking, and whether it is safe when compared to placebo (an inactive inhaler).

Detailed description

This project will examine the safety and efficacy of the nicotine inhaler as an aid to smoking cessation during pregnancy. The specific aims are: (1) To examine the efficacy of the nicotine inhaler compared to a matching placebo for smoking cessation during pregnancy; (2) To compare the nicotine inhaler with placebo on overall nicotine exposure (i.e., serum cotinine concentrations), and on birth outcomes (i.e., birth weight and gestational age); (3) To identify factors that determine which women benefit most from the use of the nicotine inhaler for smoking cessation during pregnancy; (4) To explore mechanisms by which the nicotine inhaler increases birth weight and gestational age. Subjects will be recruited from two prenatal clinics that serve primarily a low-income, minority population. Pregnant smokers (n=270) who smoke at least 5 cigarettes/ day will receive nurse-delivered behavioral counseling and be randomized to receive a 6-week course of treatment with either a nicotine inhaler or placebo, followed by a 6-week taper. Birth outcomes will be obtained on all participants

Conditions

• Nicotine Dependence
• Smoking Cessation

Interventions

Type	Name	Description
DRUG	Nicotrol Inhaler	Nicotrol Inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper
DRUG	Placebo Inhaler	Placebo inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper

Timeline

• Start date: 2012-08-01
• Primary completion: 2017-09-30
• Completion: 2017-10-25
• First posted: 2012-08-03
• Last updated: 2019-09-30
• Results posted: 2019-09-30

Locations

2 sites across 1 country: United States