Pilot Study of Nicotine Replacement for Smoking Cessation During Pregnancy

Hartford Hospital10 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Tobacco Use Disorder

Interventions

Nicotrol InhalerDRUG

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

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Hartford Hospital

Hartford, Connecticut, United States

Outcomes

Primary Outcomes

Number of Days of Inhaler Use

Time frame: Baseline to 4 weeks

Secondary Outcomes

Cartridge Use

Time frame: Baseline to 4 weeks

Change in Number of Cigarettes Used Per Day From Baseline to 4 Weeks.

Time frame: Baseline to 4 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.