Nicotine Replacement for Smoking Cessation During Pregnancy

UConn Health

Status and phase: Completed; Phase 4

Conditions: Nicotine Dependence; Smoking Cessation

Treatments: Drug: Placebo Inhaler; Drug: Nicotrol Inhaler

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01656733

1R01HD069314-01A1 (U.S. NIH Grant/Contract)

11-057-6

Details and patient eligibility

About

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).

Full description

This project will examine the safety and efficacy of the nicotine inhaler as an aid to smoking cessation during pregnancy. The specific aims are: (1) To examine the efficacy of the nicotine inhaler compared to a matching placebo for smoking cessation during pregnancy; (2) To compare the nicotine inhaler with placebo on overall nicotine exposure (i.e., serum cotinine concentrations), and on birth outcomes (i.e., birth weight and gestational age); (3) To identify factors that determine which women benefit most from the use of the nicotine inhaler for smoking cessation during pregnancy; (4) To explore mechanisms by which the nicotine inhaler increases birth weight and gestational age.

Subjects will be recruited from two prenatal clinics that serve primarily a low-income, minority population.

Pregnant smokers (n=270) who smoke at least 5 cigarettes/ day will receive nurse-delivered behavioral counseling and be randomized to receive a 6-week course of treatment with either a nicotine inhaler or placebo, followed by a 6-week taper. Birth outcomes will be obtained on all participants

Enrollment: 154 patients

Sex: Female

Ages: 16+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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154 participants in 2 patient groups, including a placebo group

Nicotrol Inhaler

Experimental group

Description:

Nicotrol Inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper.

Treatment:

Drug: Nicotrol Inhaler

Placebo Inhaler

Placebo Comparator group

Description:

Placebo inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper

Treatment:

Drug: Placebo Inhaler