Status:
TERMINATED
Testing Pharmacological Therapies for Pregnant Smokers
Lead Sponsor:
Duke University
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Smoking
Pregnancy
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief Summary
Nicotine dependence has not been sufficiently addressed in current state-of-the-science cessation interventions for pregnant smokers. The weight of the evidence from the general population of smokers ...
Detailed Description
The proposed five-year study is designed to evaluate the effectiveness of providing over-the-counter (OTC) nicotine replacement therapy, choice of gum, lozenge or patch, (NRT) to promote prepartum smo...
Eligibility Criteria
Inclusion
- Be at least 18 years of age
- Be between 13 and 25 weeks of pregnancy
- Be receiving prenatal care at one of the participating clinics
- Have smoked at least 100 cigarettes in their lifetime
- Be currently smoking and have smoked at least 5 cigarettes per day in the past 7 days
- Speak and write English
Exclusion
- Evidence of cognitive or mental health problems
- Evidence of possible drug or alcohol addiction
- Documented history in medical chart of mental retardation, significant chronic or recurrent psychiatric disorder such as schizophrenia or severe depression, history of cardiac arrhythmias, history of myocardial infarction within the past 6 months, history of previous pregnancy with congenital anomaly,family history of congenital anomalies
- Complications of pregnancy during the current pregnancy, including: threatened miscarriage, congenital anomalies, unexplained vaginal bleeding, pelvic or abdominal surgical procedures, deep venous thrombosis, malignancy
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
181 Patients enrolled
Trial Details
Trial ID
NCT00224419
Start Date
June 1 2003
Last Update
July 21 2014
Active Locations (2)
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1
Duke University Medical Center
Durham, North Carolina, United States, 27710
2
Womack Army Medical Center
Fayetteville, North Carolina, United States, 28310