Nicotine Replacement for Smoking Cessation During Pregnancy

Study Overview
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Brief Summary
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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
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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

Official Title
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Nicotine Replacement for Smoking Cessation During Pregnancy

Conditions
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Nicotine Dependence, Smoking Cessation

Intervention / Treatment
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* Drug: Nicotrol Inhaler
* Drug: Placebo Inhaler


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nicotrol Inhaler<br>Nicotrol Inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper. | Drug: Nicotrol Inhaler<br>* Nicotrol Inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper<br>* Other names: Nicotine Inhaler;|
| Placebo Comparator: Placebo Inhaler<br>Placebo inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper | Drug: Placebo Inhaler<br>* Placebo inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smoking Cessation, Pregnancy, Nicotrol Inhaler, Placebo Inhaler, Nicotine Inhaler