Nicotine Replacement for Smoking Cessation During Pregnancy
| Status: | Completed |
|---|---|
| Conditions: | Smoking Cessation, Tobacco Consumers |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 16 - Any |
| Updated: | 4/17/2018 |
| Start Date: | December 2010 |
| End Date: | October 25, 2017 |
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).
will help pregnant women quit smoking, and whether it is safe when compared to placebo (an
inactive inhaler).
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
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
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
We found this trial at
2
sites
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