Project 4, Study 2: Extended Exposure to Low Nicotine Content Cigarettes in Pregnant Women
2 other identifiers
interventional
30
1 country
2
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 conditions: usual brand vs. 0.4 mg nicotine/g tobacco. After a baseline period in which daily smoking rate and other baseline assessments are completed, participants will be randomly (by chance) assigned to either their usual brand or the very low nicotine content condition and followed for 12 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Aug 2019
Longer than P75 for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 23, 2019
CompletedFirst Posted
Study publicly available on registry
July 26, 2019
CompletedStudy Start
First participant enrolled
August 21, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 17, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 19, 2024
CompletedResults Posted
Study results publicly available
October 30, 2025
CompletedOctober 30, 2025
October 1, 2025
4.7 years
July 23, 2019
September 9, 2025
October 16, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Total Cigarettes Per Day
12 weeks
Study Arms (2)
Very low nicotine content cigarettes
EXPERIMENTALUsual Brand
NO INTERVENTIONInterventions
Cigarettes containing 0.4 mg nicotine/g tobacco
Eligibility Criteria
You may qualify if:
- Female
- Ages 18-44 years
- Gestational age ≤ 25 weeks
You may not qualify if:
- Male
- Under 18 years old
- Over 44 years old
- Gestational age \> 25 weeks
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Vermontlead
- National Institute on Drug Abuse (NIDA)collaborator
- Food and Drug Administration (FDA)collaborator
- University of Kentuckycollaborator
Study Sites (2)
University of Kentucky
Lexington, Kentucky, 40536, United States
University of Vermont
Burlington, Vermont, 05401, United States
Related Publications (1)
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 Dec;201:108351. doi: 10.1016/j.ypmed.2025.108351. Epub 2025 Jul 5.
PMID: 40623557DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The sample included participants who smoke more than is typical during pregnancy and the sample size (N=30) was small. Study generality may be limited by the high smoking rate and the small sample size.
Results Point of Contact
- Title
- Sarah H. Heil, PhD
- Organization
- University of Vermont
Study Officials
- PRINCIPAL INVESTIGATOR
Sarah H. Heil
University of Vermont
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 23, 2019
First Posted
July 26, 2019
Study Start
August 21, 2019
Primary Completion
April 17, 2024
Study Completion
August 19, 2024
Last Updated
October 30, 2025
Results First Posted
October 30, 2025
Record last verified: 2025-10