NCT04033237

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University of Vermont · Academic / Other
• Sex: Female
• Age: 18 Years – 44 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Tobacco Use Disorder

Interventions

Type	Name	Description
OTHER	Very low nicotine content cigarettes	Cigarettes containing 0.4 mg nicotine/g tobacco

Timeline

• Start date: 2019-08-21
• Primary completion: 2024-04-17
• Completion: 2024-08-19
• First posted: 2019-07-26
• Last updated: 2025-10-30
• Results posted: 2025-10-30

Locations

2 sites across 1 country: United States