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

• Sponsor: University of Vermont (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04033237
• Collaborator: National Institute on Drug Abuse (NIDA) (NIH), Food and Drug Administration (FDA) (U.S. Fed), University of Kentucky (Other)
• Enrollment: 111
• Locations: 2
• Arms: 2
• Anticipated Duration (Months): 46.3
• Patients Per Site: 55.5
• Patients Per Site Per Month: 1.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Tobacco Use Disorder	Other: Very low nicotine content cigarettes	Phase 1/Phase 2

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 111 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Project 4, Study 2: Extended Exposure to Low Nicotine Content Cigarettes in Pregnant Women
• Actual Study Start Date: Aug 21, 2019
• Anticipated Primary Completion Date: Jul 1, 2023
• Anticipated Study Completion Date: Jul 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Very low nicotine content cigarettes	Other: Very low nicotine content cigarettes; Cigarettes containing 0.4 mg nicotine/g tobacco
No Intervention: Usual Brand

Outcome Measures

Primary Outcome Measures

1. Cigarettes per day [12 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 44 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Kentucky	Lexington	Kentucky	United States	40536
2	University of Vermont	Burlington	Vermont	United States	05401

Sponsors and Collaborators

• University of Vermont
• National Institute on Drug Abuse (NIDA)
• Food and Drug Administration (FDA)
• University of Kentucky

Investigators

• Principal Investigator: Sarah H. Heil, University of Vermont

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sarah Heil, Professor, University of Vermont
• ClinicalTrials.gov Identifier: NCT04033237
• Other Study ID Numbers: CHRMS 16-390; U54DA036114
• First Posted: Jul 26, 2019
• Last Update Posted: Apr 11, 2022
• Last Verified: Mar 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Sarah Heil, Professor, University of Vermont: Biomarkers of exposure; Compensatory smoking; Nicotine dependence; Reduced nicotine cigarettes; Tobacco withdrawal; Women; Pregnancy; Health disparities; Vulnerable populations
• Additional relevant MeSH terms: Tobacco Use Disorder; Nicotine

Study Results

No Results Posted as of Apr 11, 2022