Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00224419
Status:
TERMINATED
Last Update Posted:
2014-07-21
First Post:
2005-09-21
Brief Title:
Testing Pharmacological Therapies for Pregnant Smokers
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Testing Pharmacological Therapies for Pregnant Smokers
Status:
TERMINATED
Status Verified Date:
2009-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
was terminated due to meeting a priori stopping rule set by DSMB
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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 smoking cessation Proposed is a two-arm design Eligible pregnant women N300 will be randomized to either Arm 1 Tailored Cognitive Behavioral Treatment TCBT n100 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 n200 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Duke University IRB 2865 | None | None | None |
| CA89053 | OTHER | DUMC | None |