Nicotine Replacement for Smoking Cessation During Pregnancy

September 27, 2019 updated by: Cheryl Oncken, UConn Health
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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 32-34 weeks gestation (Visit 6)
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
Time Frame: 32-34 weeks gestation
As measured by parts per million (ppm) on CO breathalyzer
32-34 weeks gestation
Birth Weight
Time Frame: At delivery
Birth weight in grams
At delivery
Gestational Age
Time Frame: At delivery
Measure of age of pregnancy at delivery
At delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-057-6
  • 1R01HD069314-01A1 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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