Pilot Study of Nicotine Replacement for Smoking Cessation During Pregnancy

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2014-04-30

Brief Summary

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We plan to examine the feasibility, acceptability, preliminary quit rates, overall nicotine exposure and adverse effects of the nicotine inhaler for smoking cessation in pregnancy.

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Detailed Description

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Subjects in this pilot study are healthy pregnant women who wish to quit smoking. They will set a quit date and use the nicotine inhaler for 4 weeks. They will receive behavioral counseling in addition to the inhaler for 4 weeks.

Conditions

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Tobacco Use Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Nicotrol with Behavioral Counseling

Nicotrol Inhaler: 10 mg of nicotine per one inhaler cartridge. Inhaler use will substitute the usual smoking pattern

Group Type EXPERIMENTAL

Nicotrol Inhaler

Intervention Type DRUG

10 mg of nicotine per one inhaler cartridge. Inhaler use will substitute the usual smoking pattern

Interventions

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Nicotrol Inhaler

10 mg of nicotine per one inhaler cartridge. Inhaler use will substitute the usual smoking pattern

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 13-26 weeks pregnant
* Smoking at least 5 cigarettes per day the preceding 7 days
* Motivated to quit smoking (at least 7 on a 10 pt. scale)
* Able to speak English
* Intend to carry pregnancy to term
* Stable residence

Exclusion Criteria

* Current drug or alcohol abuse or dependence (other than methadone maintenance
* Twins or multiple gestation
* Unstable psychiatric disorder
* Unstable medical problems
* Known congenital abnormality
* High risk pregnancy

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes