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

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University of Vermont

Status and phase

Active, not recruiting
Phase 2
Phase 1

Conditions

Tobacco Use Disorder

Treatments

Other: Very low nicotine content cigarettes

Study type

Interventional

Funder types

Other
Other U.S. Federal agency
NIH

Identifiers

NCT04033237
CHRMS 16-390
U54DA036114 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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

Enrollment

66 estimated patients

Sex

Female

Ages

18 to 44 years old

Volunteers

Accepts 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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

66 participants in 2 patient groups

Very low nicotine content cigarettes
Experimental group
Treatment:
Other: Very low nicotine content cigarettes
Usual Brand
No Intervention group

Trial contacts and locations

2

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Central trial contact

Shirley Plucinski

Data sourced from clinicaltrials.gov

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