Project 4, Study 2: Extended Exposure to Low Nicotine Content Cigarettes in Pregnant Women
NCT ID: NCT04033237
Last Updated: 2025-10-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
30 participants
INTERVENTIONAL
2019-08-21
2024-08-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Very low nicotine content cigarettes
Very low nicotine content cigarettes
Cigarettes containing 0.4 mg nicotine/g tobacco
Usual Brand
No interventions assigned to this group
Interventions
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Very low nicotine content cigarettes
Cigarettes containing 0.4 mg nicotine/g tobacco
Eligibility Criteria
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Inclusion Criteria
* Ages 18-44 years
* Gestational age ≤ 25 weeks
Exclusion Criteria
* Under 18 years old
* Over 44 years old
* Gestational age \> 25 weeks
18 Years
44 Years
FEMALE
Yes
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
Food and Drug Administration (FDA)
FED
University of Kentucky
OTHER
University of Vermont
OTHER
Responsible Party
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Sarah Heil
Professor
Principal Investigators
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Sarah H. Heil
Role: PRINCIPAL_INVESTIGATOR
University of Vermont
Locations
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University of Kentucky
Lexington, Kentucky, United States
University of Vermont
Burlington, Vermont, United States
Countries
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References
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Heil SH, Kock LS, Harfmann RF, Ashford KB, Barnett J, McCubbin A, DeSarno MJ, Higgins ST. Pilot randomized clinical trial examining use of very low nicotine content cigarettes during pregnancy in the United States. Prev Med. 2025 Jul 5:108351. doi: 10.1016/j.ypmed.2025.108351. Online ahead of print.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CHRMS 16-390
Identifier Type: -
Identifier Source: org_study_id
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