Project 4, Study 2: Extended Exposure to Low Nicotine Content Cigarettes in Pregnant Women

Completed · Phase 1/Phase 2

Conditions studied: Tobacco Use Disorder

In brief

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.

Key facts

Study ID

NCT04033237

Run by

University of Vermont

People needed

30

Starts

2019-08-21

Expected to finish

2024-08-19

Last updated by the study team

2026-05-18

Who can join

Age: 18 and older, up to 44. Sex: female. Healthy volunteers: accepted.

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

Where it is running

• University of Kentucky — Lexington, Kentucky, United States
• University of Vermont — Burlington, Vermont, United States

Full record on ClinicalTrials.gov

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