NCT00888979
Completed
Not Applicable
Pilot Study of Nicotine Replacement for Smoking Cessation During Pregnancy
Overview
- Phase
- Not Applicable
- Intervention
- Nicotrol Inhaler
- Conditions
- Tobacco Use Disorder
- Sponsor
- Hartford Hospital
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Number of Days of Inhaler Use
- Status
- Completed
- Last Updated
- 9 years ago
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.
Investigators
Eligibility Criteria
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
Nicotrol Inhaler: 10 mg of nicotine per one inhaler cartridge. Inhaler use will substitute the usual smoking pattern
Intervention: Nicotrol Inhaler
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)
Study Sites (1)
Loading locations...
Similar Trials
Completed
Phase 1
Smoking Cessation Intervention for Thoracic PatientsLung CancerNCT00580398Massachusetts General Hospital49
Completed
Phase 2
Quit Smoking Study for People Who Use E-CigarettesNicotine AddictionE-Cig UseQuitting SmokingNCT04946825University of Vermont396
Completed
Phase 3
Smoking Cessation With the Nicotine Patch: A Pilot Study of Patch MessagingSmoking CessationNCT01287377University of California, San Diego243
Recruiting
Not Applicable
Nicotine Replacement Therapy Sampling for Smokers in the CommunityTobacco SmokingNCT05881083The University of Hong Kong1,014
Completed
Not Applicable
Yoga for Men Attempting Smoking CessationSmoking CessationNCT02055326The Miriam Hospital38