Pilot Study of Nicotine Replacement for Smoking Cessation During Pregnancy
- Registration Number
- NCT00888979
- Lead Sponsor
- Hartford Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 10
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Nicotrol with Behavioral Counseling Nicotrol Inhaler Nicotrol Inhaler: 10 mg of nicotine per one inhaler cartridge. Inhaler use will substitute the usual smoking pattern
- Primary Outcome Measures
Name Time Method Number of Days of Inhaler Use Baseline to 4 weeks
- Secondary Outcome Measures
Name Time Method Cartridge Use Baseline to 4 weeks Change in Number of Cigarettes Used Per Day From Baseline to 4 Weeks. Baseline to 4 weeks
Trial Locations
- Locations (1)
Hartford Hospital
🇺🇸Hartford, Connecticut, United States