Nicotine Replacement for Smoking Cessation During Pregnancy

Completed · Phase 4 · Has a placebo group

Conditions studied: Nicotine Dependence, Smoking Cessation

In brief

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).

Key facts

Study ID

NCT01656733

Run by

UConn Health

People needed

154

Starts

2012-08-01

Expected to finish

2017-10-25

Last updated by the study team

2019-09-30

Who can join

Age: 16 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Women's Ambulatory Health Services at Hartford Hospital — Hartford, Connecticut, United States
• Wesson Women's Clinic at Baystate Medical Center — Springfield, Massachusetts, United States

Full record on ClinicalTrials.gov

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