Overview

This trial is active, not recruiting.

Conditions nicotine dependence, smoking cessation
Treatment nicotrol inhaler
Phase phase 4
Sponsor UConn Health
Collaborator Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Start date December 2010
End date February 2017
Trial size 360 participants
Trial identifier NCT01656733, 11-057-6, 1R01HD069314-01A1

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
Arm
(Experimental)
Nicotrol Inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper.
nicotrol inhaler Nicotine Inhaler
Nicotrol Inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper Placebo Inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper.
(Placebo Comparator)
Placebo inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper
nicotrol inhaler Nicotine Inhaler
Nicotrol Inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper Placebo Inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper.

Primary Outcomes

Measure
7 day point prevalence (PPA)
time frame: 32-34 weeks gestation

Secondary Outcomes

Measure
Birth weights, gestational age and cotinine concentrations
time frame: 32-34 weeks gestation
Exhaled carbon monoxide and cigarettes per day (CPD)
time frame: 6 weeks and 32-34 weeks gestation
Birth Weight and gestational age
time frame: 32-34 weeks gestation

Eligibility Criteria

Female participants at least 16 years old.

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

Additional Information

Official title Nicotine Replacement for Smoking Cessation During Pregnancy
Principal investigator Cheryl Oncken, M.D., M.P.H.
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
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by UConn Health.