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

NCT04033237 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-05-18

Study results available
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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.

Conditions

  • Tobacco Use Disorder

Interventions

OTHER

Very low nicotine content cigarettes

Cigarettes containing 0.4 mg nicotine/g tobacco

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • Food and Drug Administration (FDA)

    collaborator FED

  • University of Kentucky

    collaborator OTHER

  • University of Vermont

    lead OTHER

Principal Investigators

  • Sarah H. Heil · University of Vermont

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
44 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-08-21
Primary Completion
2024-04-17
Completion
2024-08-19

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04033237 on ClinicalTrials.gov