Testing Pharmacological Therapies for Pregnant Smokers

Stopped early · Phase 4

Conditions studied: Smoking, Pregnancy

In brief

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 suggests that nicotine replacement therapies may be beneficial cessation aids for pregnant smokers who are unable to stop smoking. The tremendous potential of these therapies for promoting smoking cessation among pregnant women creates a pressing need for decision tools and protocols to encourage treatment adherence that is essential for rigorous evaluation of the effectiveness of OTC NRT when provided as part of prenatal care. The results of this research could be directly translated to the improvement of obstetrical care providers' clinical practices. Medically supervised use of OTC NRT by pregnant smokers is an alternative to continued smoking that has the potential to substantially increase rates of smoking cessation during pregnancy.

Key facts

Study ID

NCT00224419

Run by

Duke University

People needed

181

Starts

2003-06-01

Last updated by the study team

2014-07-21

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Duke University Medical Center — Durham, North Carolina, United States
• Womack Army Medical Center — Fayetteville, North Carolina, United States

Full record on ClinicalTrials.gov

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