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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

April 24, 2009
February 23, 2010
April 2009
June 2010   (final data collection date for primary outcome measure)
Cigarette abstinence [ Time Frame: At 2 and 4 weeks after quit date. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00888979 on ClinicalTrials.gov Archive Site
Cotinine concentrations [ Time Frame: At 2 and 4 weeks after treatment compared to baseline levels while smoking ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Pilot Study of Nicotine Replacement for Smoking Cessation During Pregnancy
Pilot Study of Nicotine Replacement for Smoking Cessation During Pregnancy

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.

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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Tobacco Use Disorder
Drug: Nicotrol Inhaler
10 mg of nicotine per one inhaler cartridge. Inhaler use will substitute the usual smoking pattern
Experimental: 1
Nicotrol Inhaler with Behavioral Counseling
Intervention: Drug: Nicotrol Inhaler
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10
November 2010
June 2010   (final data collection date for primary outcome measure)

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
Female
18 Years and older
Yes
Contact: Cheryl Oncken, MD 860-679-3425 oncken@nso2.uchc.edu
Contact: Sheila Thurlow, RN 860-679-4637 Thurlow@uchc.edu
United States
 
NCT00888979
ONCK002885HU, H09-183-2
No
Cheryl Oncken, MD, University of Connecticut Health Center
Hartford Hospital
University of Connecticut Health Center
Principal Investigator: Cheryl Oncken, MD MPH University of Connecticut Health Center
Hartford Hospital
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP