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

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.

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Key information

Conditions

Tobacco Use Disorder Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year–44 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of Kentucky, Lexington, Kentucky, United States

About this study

Some inclusion/exclusion criteria are purposely omitted at this time to preserve scientific integrity. They will be included after the trial is complete.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Very low nicotine content cigarettes

Other

Cigarettes containing 0.4 mg nicotine/g tobacco

Primary outcomes

Total Cigarettes Per Day

Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

University of Vermont

Other

Collaborators

Food and Drug Administration (FDA)
National Institute on Drug Abuse (NIDA)
University of Kentucky

Registry information

Important dates

Study start: 2019
Primary completion: 2024
Study completion: 2024
First posted: Jul 26, 2019
Registry last updated: May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed