Project 4, Study 2: Extended Exposure to Low Nicotine Content Cigarettes in Pregnant Women
Purpose
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
- Tobacco Use Disorder
Eligibility
- Eligible Ages
- Between 18 Years and 44 Years
- Eligible Genders
- 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
Study Design
- Phase
- Phase 1/Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Basic Science
- Masking
- None (Open Label)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental Very low nicotine content cigarettes |
|
|
No Intervention Usual Brand |
|
Recruiting Locations
More Details
- NCT ID
- NCT04033237
- Status
- Active, not recruiting
- Sponsor
- University of Vermont
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.