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Pilot Study of Nicotine Replacement for Smoking Cessation During Pregnancy

This study has been completed.
Sponsor:
Collaborator:
UConn Health
Information provided by (Responsible Party):
Hartford Hospital
ClinicalTrials.gov Identifier:
NCT00888979
First received: April 24, 2009
Last updated: November 10, 2016
Last verified: November 2016
April 24, 2009
November 10, 2016
April 2009
May 2011   (Final data collection date for primary outcome measure)
Number of Days of Inhaler Use [ Time Frame: Baseline to 4 weeks ]
Cigarette abstinence [ Time Frame: At 2 and 4 weeks after quit date. ]
Complete list of historical versions of study NCT00888979 on ClinicalTrials.gov Archive Site
  • Cartridge Use [ Time Frame: Baseline to 4 weeks ]
  • Change in Number of Cigarettes Used Per Day From Baseline to 4 Weeks. [ Time Frame: Baseline to 4 weeks ]
Cotinine concentrations [ Time Frame: At 2 and 4 weeks after treatment compared to baseline levels while smoking ]
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: Nicotrol with Behavioral Counseling
Nicotrol Inhaler: 10 mg of nicotine per one inhaler cartridge. Inhaler use will substitute the usual smoking pattern
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.
 
Completed
10
April 2014
May 2011   (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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00888979
ONCK002885HU
H09-183-2 ( Other Identifier: Hartford Hospital )
No
Not Provided
Plan to Share IPD: No
Hartford Hospital
Hartford Hospital
UConn Health
Principal Investigator: Cheryl Oncken, MD MPH UConn Health
Hartford Hospital
November 2016

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