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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

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

ArmDescriptionAssigned Intervention
Experimental
Very low nicotine content cigarettes
  • Other: Very low nicotine content cigarettes
    Cigarettes containing 0.4 mg nicotine/g tobacco
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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.