Nicotine Replacement for Smoking Cessation During Pregnancy

• Status: Completed
• Trial end date: 2017-10-25
• Target enrollment: 0
• Participant gender: Female

Summary

This is a clinical trial to determine if the nicotine inhaler in combination with counseling will help pregnant women quit smoking, and whether it is safe when compared to placebo (an inactive inhaler).

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: UConn Health
• Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Treatments: Nicotine

Criteria

Inclusion Criteria:

• smoking at least 5 cigarettes per day for the preceding 7 days

• previous attempt to quit smoking during pregnancy by self report

• 13-26 weeks gestation

• at least 16 years of age

• able to speak English or Spanish

• intent to carry pregnancy to term

• stable residence

Exclusion Criteria:

• current drug or alcohol abuse or dependence (other than methadone maintenance)

• twins or other multiple gestation

• unstable psychiatric disorder

• unstable medical problems (e.g., pre-eclampsia, threatened abortion, hyperemesis gravidarum)

• known congenital abnormality