Nicotine Replacement for Smoking Cessation During Pregnancy

Smoking Cessation Clinical Trial

Official title:

Nicotine Replacement for Smoking Cessation During Pregnancy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01656733
• Other study ID #: 11-057-6
• Secondary ID: 1R01HD069314-01A
• Status: Completed
• Phase: Phase 4
• Start date: August 2012
• Est. completion date: October 25, 2017

Study information

• Verified date: September 2019
• Source: UConn Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: October 25, 2017
• Est. primary completion date: September 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Nicotine Dependence
• Smoking Cessation
• Tobacco Use Disorder

Intervention

Drug:
• Nicotrol Inhaler
Nicotrol Inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper
• Placebo Inhaler
Placebo inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper

Locations

Country	Name	City	State
United States	Women's Ambulatory Health Services at Hartford Hospital	Hartford	Connecticut
United States	Wesson Women's Clinic at Baystate Medical Center	Springfield	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
UConn Health	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Who Self Report an Average of Zero Cigarettes Smoked Per Day in Preceding 7 Days	Number of participants who self report an average of zero cigarettes smoked per day in preceding 7 days	32-34 weeks gestation (Visit 6)
Secondary	Exhaled Carbon Monoxide	As measured by parts per million (ppm) on CO breathalyzer	32-34 weeks gestation
Secondary	Birth Weight	Birth weight in grams	At delivery
Secondary	Gestational Age	Measure of age of pregnancy at delivery	At delivery