NCT00888979CompletedNot Applicable
Pilot Study of Nicotine Replacement for Smoking Cessation During Pregnancy
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Hartford Hospital
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Number of Days of Inhaler Use
Study Overview
Brief Summary
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.
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Nicotrol with Behavioral Counseling
Experimental
Nicotrol Inhaler: 10 mg of nicotine per one inhaler cartridge. Inhaler use will substitute the usual smoking pattern
Intervention: Nicotrol Inhaler (Drug)
Outcomes
Primary Outcomes
Number of Days of Inhaler Use
Time Frame: Baseline to 4 weeks
Secondary Outcomes
- Cartridge Use(Baseline to 4 weeks)
- Change in Number of Cigarettes Used Per Day From Baseline to 4 Weeks.(Baseline to 4 weeks)
Investigators
Study Sites (1)
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