Nicotine Replacement for Smoking Cessation During Pregnancy

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by University of Connecticut Health Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Cheryl Oncken, University of Connecticut Health Center
ClinicalTrials.gov Identifier:
NCT01656733
First received: August 1, 2012
Last updated: June 19, 2013
Last verified: June 2013
  Purpose

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).


Condition Intervention Phase
Nicotine Dependence
Smoking Cessation
Drug: Nicotrol Inhaler
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Nicotine Replacement for Smoking Cessation During Pregnancy

Resource links provided by NLM:


Further study details as provided by University of Connecticut Health Center:

Primary Outcome Measures:
  • 7 day point prevalence (PPA) [ Time Frame: 32-34 weeks gestation ] [ Designated as safety issue: No ]
    To examine the efficacy of the nicotine inhaler compared to a matched placebo for smoking cessation and reduction among pregnant smokers.


Secondary Outcome Measures:
  • Birth weights, gestational age and cotinine concentrations [ Time Frame: 32-34 weeks gestation ] [ Designated as safety issue: No ]
    To compare the nicotine inhaler with placebo on safety measures which include a) overall nicotine exposure (i.e. serum cotinine) and birth outcomes (i.e. birth weight and gestational age)

  • Exhaled carbon monoxide and cigarettes per day (CPD) [ Time Frame: 6 weeks and 32-34 weeks gestation ] [ Designated as safety issue: No ]
    To identify factors that determine which women benefit most from the use of nicotine inhaler for smoking cessation during pregnancy.

  • Birth Weight and gestational age [ Time Frame: 32-34 weeks gestation ] [ Designated as safety issue: No ]
    To explore mechanisms by which the nicotine inhaler increases birth weight and gestational age.


Estimated Enrollment: 360
Study Start Date: December 2010
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Placebo Inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper.
Other Names:
  • Nicitine Inhaler
  • Placebo Inhaler
Placebo Comparator: Placebo Inhaler
Placebo 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 Placebo Inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper.
Other Names:
  • Nicitine Inhaler
  • 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

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01656733

Contacts
Contact: Sheila D. Thurlow, M.S.N., R.N. 860-679-4637 thurlow@uchc.edu

Locations
United States, Connecticut
Women's Ambulatory Health Services at Hartford Hospital Recruiting
Hartford, Connecticut, United States, 06106
Contact: Lindsay Lorson, B.S.    860-545-1295    llorson@harthosp.org   
Sub-Investigator: Ellen Dornelas, Ph.D.         
United States, Massachusetts
Wesson Women's Clinic at Baystate Medical Center Recruiting
Springfield, Massachusetts, United States, 01199
Sub-Investigator: Heather Sankey, M.D.         
Sponsors and Collaborators
University of Connecticut Health Center
Investigators
Principal Investigator: Cheryl Oncken, M.D., M.P.H. University of Connecticut Health Center
  More Information

No publications provided

Responsible Party: Cheryl Oncken, Professor of Medicine, University of Connecticut Health Center
ClinicalTrials.gov Identifier: NCT01656733     History of Changes
Other Study ID Numbers: 11-057-6, 1R01HD069314-01A1
Study First Received: August 1, 2012
Last Updated: June 19, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Connecticut Health Center:
Smoking Cessation
Pregnancy
Nicotrol Inhaler
Placebo Inhaler
Nicotine Inhaler

Additional relevant MeSH terms:
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014