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

Primary Purpose

Tobacco Use Disorder

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Very low nicotine content cigarettes
Sponsored by
University of Vermont
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Tobacco Use Disorder focused on measuring Biomarkers of exposure, Compensatory smoking, Nicotine dependence, Reduced nicotine cigarettes, Tobacco withdrawal, Women, Pregnancy, Health disparities, Vulnerable populations

Eligibility Criteria

18 Years - 44 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of KentuckyRecruiting
  • University of VermontRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Very low nicotine content cigarettes

Usual Brand

Arm Description

Outcomes

Primary Outcome Measures

Cigarettes per day

Secondary Outcome Measures

Full Information

First Posted
July 23, 2019
Last Updated
November 30, 2022
Sponsor
University of Vermont
Collaborators
National Institute on Drug Abuse (NIDA), Food and Drug Administration (FDA), University of Kentucky
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1. Study Identification

Unique Protocol Identification Number
NCT04033237
Brief Title
Project 4, Study 2: Extended Exposure to Low Nicotine Content Cigarettes in Pregnant Women
Official Title
Project 4, Study 2: Extended Exposure to Low Nicotine Content Cigarettes in Pregnant Women
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 21, 2019 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
July 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Vermont
Collaborators
National Institute on Drug Abuse (NIDA), Food and Drug Administration (FDA), University of Kentucky

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Use Disorder
Keywords
Biomarkers of exposure, Compensatory smoking, Nicotine dependence, Reduced nicotine cigarettes, Tobacco withdrawal, Women, Pregnancy, Health disparities, Vulnerable populations

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Very low nicotine content cigarettes
Arm Type
Experimental
Arm Title
Usual Brand
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Very low nicotine content cigarettes
Intervention Description
Cigarettes containing 0.4 mg nicotine/g tobacco
Primary Outcome Measure Information:
Title
Cigarettes per day
Time Frame
12 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shirley Plucinski
Phone
802-656-9619
Email
shirley.plucinski@uvm.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah H. Heil
Organizational Affiliation
University of Vermont
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea McCubbin
Phone
859-323-6650
Email
akmccu0@uky.edu
First Name & Middle Initial & Last Name & Degree
Kristin Ashford
Facility Name
University of Vermont
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shirley Plucinski
Phone
802-656-9619
Email
shirley.plucinski@uvm.edu
First Name & Middle Initial & Last Name & Degree
Sarah H Heil, PhD

12. IPD Sharing Statement

Learn more about this trial

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

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