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

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)

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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