Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Duke University National Cancer Institute (NCI) |
---|---|
Information provided by: | Duke University |
ClinicalTrials.gov Identifier: | NCT00224419 |
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.
Condition | Intervention | Phase |
---|---|---|
Smoking Pregnancy |
Behavioral: Motivational interviewing for smoking cessation Drug: Patient choice of nicotine replacement (patch, gum, lozenge) |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Testing Pharmacological Therapies for Pregnant Smokers |
Estimated Enrollment: | 300 |
Study Start Date: | June 2003 |
Estimated Study Completion Date: | April 2006 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, North Carolina | |
Duke University Medical Center | |
Durham, North Carolina, United States, 27710 | |
Womack Army Medical Center | |
Fayetteville, North Carolina, United States, 28310 |
Principal Investigator: | Evan Myers, MD, MPH | Duke University |
Study ID Numbers: | CA89053, Duke University IRB #2865 |
Study First Received: | September 21, 2005 |
Last Updated: | June 1, 2006 |
ClinicalTrials.gov Identifier: | NCT00224419 |
Health Authority: | United States: Food and Drug Administration |
Smoking cessation Pregnancy Nicotine replacement therapy Motivational interviewing |
Nicotine polacrilex Smoking Nicotine |
Habits Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Cholinergic Agonists Autonomic Agents Nicotinic Agonists |
Physiological Effects of Drugs Ganglionic Stimulants Peripheral Nervous System Agents Cholinergic Agents Pharmacologic Actions |