Nicotine Replacement for Smoking Cessation During Pregnancy

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

154 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2017-10-25

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).

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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

Conditions

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Nicotine Dependence Smoking Cessation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Nicotrol Inhaler

Nicotrol Inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper.

Group Type EXPERIMENTAL

Nicotrol Inhaler

Intervention Type DRUG

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

Group Type PLACEBO_COMPARATOR

Placebo Inhaler

Intervention Type DRUG

Placebo inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper

Interventions

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Nicotrol Inhaler

Nicotrol Inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper

Intervention Type DRUG

Placebo Inhaler

Placebo inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper

Intervention Type DRUG

Other Intervention Names

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Nicotine Inhaler

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

Minimum Eligible Age

16 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes