Status:
TERMINATED
Nicotine Replacement Treatment for Pregnant Smokers - 1
Lead Sponsor:
National Institute on Drug Abuse (NIDA)
Conditions:
Tobacco Use Disorder
Eligibility:
FEMALE
16-50 years
Phase:
PHASE2
Brief Summary
Smoking during pregnancy is an important modifiable cause of poor pregnancy outcomes. Even with augmented behavioral interventions, smoking cessation rates in pregnancy trials rarely exceed 20%. These...
Detailed Description
This proposal will examine the utility of one first-line medication, nicotine gum, as an aid to smoking cessation during pregnancy. The specific aims are: * (1) To compare smoking cessation rates an...
Eligibility Criteria
Inclusion
- Patient's gestational age is 26 weeks or less.
- Patient is at least 16 years of age.
- Patient is able to speak English or Spanish.
- Patient intends to carry to term.
- Patient has stable residence.
- Patient has smoked five or more cigarettes everyday for the past seven days.
Exclusion
- Evidence that the patient is pregnant with a fetus with a known congenital abnormality.
- Unstable medical problems (i.e., hyperthyroidism, temporomandibular joint disorder, pre-eclampsia, threatened abortion, hyperemesis gravidarum)
- Multiple Gestation
- Unstable psychiatric disorder
- Current drug or alcohol abuse or dependence
Key Trial Info
Start Date :
June 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2007
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT00115687
Start Date
June 1 2002
End Date
April 1 2007
Last Update
January 12 2017
Active Locations (4)
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1
University of Connecticut Health Center
Farmington, Connecticut, United States, 06030
2
Hartford Hospital
Hartford, Connecticut, United States, 06106
3
The Hospital of Central Connecticut
New Britain, Connecticut, United States, 06050
4
Baystate Medical Center
Springfield, Massachusetts, United States, 01199