CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 30 enrolled
Drug / intervention
Very low nicotine content cigarettesother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04033237
NCT04033237Phase 2Completed
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Project 4, Study 2: Extended Exposure to Low Nicotine Content Cigarettes in Pregnant Women

University of Vermont·interventional·Posted Jul 26, 2019·Updated May 18, 2026

In Brief

A Phase 2 clinical trial evaluating Very low nicotine content cigarettes for Tobacco Use Disorder. Completed, enrolled 30 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTobacco Use Disorder
CountriesUnited States
CollaboratorsNational Institute on Drug Abuse (NIDA), Food and Drug Administration (FDA), University of Kentucky

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedJul 26, 2019
Enrollment StartAug 21, 2019
Primary CompletionApr 17, 2024
Study CompletionAug 19, 2024
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 6.9 years ago

Interventions

Very low nicotine content cigarettesother

Cigarettes containing 0.4 mg nicotine/g tobacco