Nicotine Replacement for Smoking Cessation During Pregnancy

Status Completed

Clinical Trial 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).

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01656733
Study type	Interventional
Source	UConn Health
Contact
Status	Completed
Phase	Phase 4
Start date	August 2012
Completion date	October 25, 2017

View Details

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