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Pilot Study of Nicotine Replacement for Smoking Cessation During Pregnancy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by Hartford Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
University of Connecticut Health Center
Information provided by:
Hartford Hospital
ClinicalTrials.gov Identifier:
NCT00888979
First received: April 24, 2009
Last updated: February 23, 2010
Last verified: February 2010
History of Changes
  Purpose

We plan to examine the feasibility, acceptability, preliminary quit rates, overall nicotine exposure and adverse effects of the nicotine inhaler for smoking cessation in pregnancy.


Condition Intervention
Tobacco Use Disorder
 Drug: Nicotrol Inhaler

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Study of Nicotine Replacement for Smoking Cessation During Pregnancy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hartford Hospital:

Primary Outcome Measures:
  • Cigarette abstinence [ Time Frame: At 2 and 4 weeks after quit date. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cotinine concentrations [ Time Frame: At 2 and 4 weeks after treatment compared to baseline levels while smoking ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: April 2009
Estimated Study Completion Date: November 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Nicotrol Inhaler with Behavioral Counseling
 Drug: Nicotrol Inhaler
10 mg of nicotine per one inhaler cartridge. Inhaler use will substitute the usual smoking pattern

Detailed Description:

Subjects in this pilot study are healthy pregnant women who wish to quit smoking. They will set a quit date and use the nicotine inhaler for 4 weeks. They will receive behavioral counseling in addition to the inhaler for 4 weeks.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 13-26 weeks pregnant
  • Smoking at least 5 cigarettes per day the preceding 7 days
  • Motivated to quit smoking (at least 7 on a 10 pt. scale)
  • Able to speak English
  • Intend to carry pregnancy to term
  • Stable residence

Exclusion Criteria:

  • Current drug or alcohol abuse or dependence (other than methadone maintenance
  • Twins or multiple gestation
  • Unstable psychiatric disorder
  • Unstable medical problems
  • Known congenital abnormality
  • High risk pregnancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00888979

Contacts
Contact: Cheryl Oncken, MD 860-679-3425 oncken@nso2.uchc.edu
Contact: Sheila Thurlow, RN 860-679-4637 Thurlow@uchc.edu

Locations
United States, Connecticut
Hartford Hospital Recruiting
Hartford, Connecticut, United States, 06102
Contact: Ellen Dornelis, Ph.D     860-545-3086     edornel@harthosp.org    
Contact: John F Greene, MD     860-545-5223     jgreene@harthosp.org    
Sub-Investigator: Ellen Dornelis, Ph.D            
Sub-Investigator: John F. Greene, MD            
Sponsors and Collaborators
Hartford Hospital
University of Connecticut Health Center
Investigators
Principal Investigator: Cheryl Oncken, MD MPH University of Connecticut Health Center
  More Information

No publications provided

Responsible Party: Cheryl Oncken, MD, University of Connecticut Health Center
ClinicalTrials.gov Identifier: NCT00888979     History of Changes
Other Study ID Numbers: ONCK002885HU, H09-183-2
Study First Received: April 24, 2009
Last Updated: February 23, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Hartford Hospital:
Smoking Cessation during Pregnancy
Nicotrol Inhaler

Additional relevant MeSH terms:
Smoking
Tobacco Use Disorder
Habits
Substance-Related Disorders
Mental Disorders
Nicotine
Nicotine polacrilex
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
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013