Status:
COMPLETED
Project 4, Study 2: Extended Exposure to Low Nicotine Content Cigarettes in Pregnant Women
Lead Sponsor:
University of Vermont
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Food and Drug Administration (FDA)
Conditions:
Tobacco Use Disorder
Eligibility:
FEMALE
18-44 years
Phase:
PHASE1
PHASE2
Brief Summary
Study 2 will evaluate the effects of extended exposure to cigarettes with varying levels of nicotine in pregnant smokers who have less than an Associate's degree. This study will be limited to two con...
Detailed Description
Some inclusion/exclusion criteria are purposely omitted at this time to preserve scientific integrity. They will be included after the trial is complete.
Eligibility Criteria
Inclusion
- Female
- Ages 18-44 years
- Gestational age ≤ 25 weeks
Exclusion
- Male
- Under 18 years old
- Over 44 years old
- Gestational age \> 25 weeks
Key Trial Info
Start Date :
August 21 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 19 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04033237
Start Date
August 21 2019
End Date
August 19 2024
Last Update
October 30 2025
Active Locations (2)
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1
University of Kentucky
Lexington, Kentucky, United States, 40536
2
University of Vermont
Burlington, Vermont, United States, 05401