Phase 2
N=30
Project 4, Study 2: Extended Exposure to Low Nicotine Content Cigarettes in Pregnant Women
Tobacco Use Disorder
Bottom Line
View on ClinicalTrials.gov: NCT04033237 ↗Enrolled (actual)
30
Serious AEs
3.3%
Results posted
Oct 2025
Primary outcome: Primary: Total Cigarettes Per Day — 16.31; 18.36 Cigarettes per day
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Very low nicotine content cigarettes (Other)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Vermont
- Primary completion
- Apr 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Cigarettes Per Day |
16.31; 18.36 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Female
- Ages 18-44 years
- Gestational age ≤ 25 weeks
Exclusion Criteria
- Male
- Under 18 years old
- Over 44 years old
- Gestational age > 25 weeks
Data sourced from ClinicalTrials.gov (NCT04033237). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.