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NCT04033237 Clinical Trial

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

Tobacco Use Disorder Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04033237
Other study ID # CHRMS 16-390
Secondary ID U54DA036114
Status Active, not recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date August 21, 2019
Est. completion date July 2024

Study information
Verified date February 2024
Source University of Vermont
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 66
Est. completion date July 2024
Est. primary completion date July 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 44 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Very low nicotine content cigarettes
Cigarettes containing 0.4 mg nicotine/g tobacco

Locations
Country Name City State
United States University of Vermont Burlington Vermont
United States University of Kentucky Lexington Kentucky

Sponsors (4)
Lead Sponsor Collaborator
University of Vermont Food and Drug Administration (FDA), National Institute on Drug Abuse (NIDA), University of Kentucky

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Cigarettes per day 12 weeks
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