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

Phase 1

Active, not recruiting

• Conditions: Tobacco Use Disorder
• Interventions: Other: Very low nicotine content cigarettes

• Registration Number: NCT04033237
• Lead Sponsor: University of Vermont

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.

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.

Study Timeline

• Study First Submitted: 2019-07-23
• Study First Submitted QC: 2019-07-23
• Study First Posted: 2019-07-26
• Study Start: 2019-08-21
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-06
• Last Update Posted: 2024-02-07
• Primary Completion: 2024-07
• Study Completion: 2024-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 66

Inclusion Criteria

• Female
• Ages 18-44 years
• Gestational age ≤ 25 weeks

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Exclusion Criteria

• Male
• Under 18 years old
• Over 44 years old
• Gestational age > 25 weeks

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Very low nicotine content cigarettes	Very low nicotine content cigarettes	-

Primary Outcome Measures

Name	Time	Method
Cigarettes per day	12 weeks

Trial Locations

Locations (2)

University of Kentucky; 🇺🇸 Lexington, Kentucky, United States

University of Vermont; 🇺🇸 Burlington, Vermont, United States