Nicotine Replacement for Smoking Cessation During Pregnancy

Phase 4

Completed

• Conditions: Nicotine Dependence; Smoking Cessation
• Interventions: Drug: Placebo Inhaler; Drug: Nicotrol Inhaler

• Registration Number: NCT01656733
• Lead Sponsor: UConn Health

Brief 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

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-08-01
• Study First Submitted QC: 2012-08-01
• Study First Posted: 2012-08-03
• Primary Completion: 2017-09-30
• Study Completion: 2017-10-25
• Results First Submitted: 2019-01-31
• Status Verified: 2019-09
• Results First Submitted QC: 2019-09-27
• Last Update Submitted: 2019-09-27
• Results First Posted: 2019-09-30
• Last Update Posted: 2019-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 154

Inclusion Criteria

• smoking at least 5 cigarettes per day for the preceding 7 days
• previous attempt to quit smoking during pregnancy by self report
• 13-26 weeks gestation
• at least 16 years of age
• able to speak English or Spanish
• intent to carry pregnancy to term
• stable residence

Exclusion Criteria

• current drug or alcohol abuse or dependence (other than methadone maintenance)
• twins or other multiple gestation
• unstable psychiatric disorder
• unstable medical problems (e.g., pre-eclampsia, threatened abortion, hyperemesis gravidarum)
• known congenital abnormality

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Inhaler	Placebo Inhaler	Placebo inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper
Nicotrol Inhaler	Nicotrol Inhaler	Nicotrol Inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper.

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Self Report an Average of Zero Cigarettes Smoked Per Day in Preceding 7 Days	32-34 weeks gestation (Visit 6)	Number of participants who self report an average of zero cigarettes smoked per day in preceding 7 days

Secondary Outcome Measures

Name	Time	Method
Exhaled Carbon Monoxide	32-34 weeks gestation	As measured by parts per million (ppm) on CO breathalyzer
Birth Weight	At delivery	Birth weight in grams
Gestational Age	At delivery	Measure of age of pregnancy at delivery

Trial Locations

Locations (2)

Women's Ambulatory Health Services at Hartford Hospital; 🇺🇸 Hartford, Connecticut, United States

Wesson Women's Clinic at Baystate Medical Center; 🇺🇸 Springfield, Massachusetts, United States