Nicotine Replacement for Smoking Cessation During Pregnancy

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).

Study Overview

• Status: Completed
• Conditions: Smoking Cessation; Nicotine Dependence
• Intervention / Treatment: Drug: Nicotrol Inhaler; Drug: Placebo Inhaler

Detailed 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

• Study Type: Interventional
• Enrollment (Actual): 154
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Hartford, Connecticut, United States, 06106
      • Women's Ambulatory Health Services at Hartford Hospital
  • Massachusetts
    • Springfield, Massachusetts, United States, 01199
      • Wesson Women's Clinic at Baystate Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nicotrol Inhaler; Nicotrol Inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper.	Drug: Nicotrol Inhaler; Nicotrol Inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper; Other Names: Nicotine Inhaler
Placebo Comparator: Placebo Inhaler; Placebo inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper	Drug: Placebo Inhaler; Placebo inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Self Report an Average of Zero Cigarettes Smoked Per Day in Preceding 7 Days	Number of participants who self report an average of zero cigarettes smoked per day in preceding 7 days	32-34 weeks gestation (Visit 6)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exhaled Carbon Monoxide	As measured by parts per million (ppm) on CO breathalyzer	32-34 weeks gestation
Birth Weight	Birth weight in grams	At delivery
Gestational Age	Measure of age of pregnancy at delivery	At delivery

Collaborators and Investigators

• Sponsor: UConn Health
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Principal Investigator: Cheryl Oncken, M.D., M.P.H., UConn Health

Publications and helpful links

General Publications

• Oncken C, Dornelas EA, Kuo CL, Sankey HZ, Kranzler HR, Mead EL, Thurlow MSD. Randomized Trial of Nicotine Inhaler for Pregnant Smokers. Am J Obstet Gynecol MFM. 2019 Mar;1(1):10-18. doi: 10.1016/j.ajogmf.2019.03.006. Epub 2019 Mar 27.

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Actual): September 30, 2017
• Study Completion (Actual): October 25, 2017

Study Registration Dates

• First Submitted: August 1, 2012
• First Submitted That Met QC Criteria: August 1, 2012
• First Posted (Estimate): August 3, 2012

Study Record Updates

• Last Update Posted (Actual): September 30, 2019
• Last Update Submitted That Met QC Criteria: September 27, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Pregnancy; Smoking Cessation; Nicotrol Inhaler; Placebo Inhaler; Nicotine Inhaler
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: 11-057-6; 1R01HD069314-01A1 (U.S. NIH Grant/Contract)