Testing Pharmacological Therapies for Pregnant Smokers

Status Terminated

Clinical Trial 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 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.

Clinical Trial 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 smoking cessation. Proposed is a two-arm design. Eligible pregnant women (N=300) will be randomized to either: Arm 1, Tailored Cognitive Behavioral Treatment (TCBT, n=100) that provides women with customized risk information about smoking and nicotine, the potential harms to the fetus and encouragement of appropriate behavioral skills building; or Arm 2, TCBT + NRT - the tailored intervention incorporating NRT information plus choice of patch or gum (n=200). The intervention will include 5 face-to-face contacts as part of prenatal visits and 1 telephone counseling session. Primary outcome measures will be biochemically validated 7-day prevalent abstinence rates at the 19-27th and 29-37th week of pregnancy. Secondary outcomes will include 7-day prevalent abstinence rates at 12 weeks postpartum, serious quit attempts, compliance with NRT, and use of materials. Saliva cotinine will be measured among all women at baseline, the 27-35th week of pregnancy, and 12 weeks postpartum. The significance of this project is that it relies on transdisciplinary collaborations to extend the science in nicotine replacement therapies to a population that could derive substantial health benefits. Moreover, the study results have immediate potential to inform clinical recommendations for integrating nicotine replacement into prenatal care. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00224419
Study type	Interventional
Source	Duke University
Contact
Status	Terminated
Phase	Phase 4
Start date	June 2003

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.