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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
Results First Received: July 10, 2015  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Tobacco Use Disorder
Intervention: Drug: Nicotrol Inhaler

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Nicotrol Inhaler With Behavioral Counseling Nicotrol Inhaler: 10 mg of nicotine per one inhaler cartridge. Inhaler use will substitute the usual smoking pattern

Participant Flow:   Overall Study
    Nicotrol Inhaler With Behavioral Counseling
STARTED   10 
Received the Inhaler/Counseling   8 
COMPLETED   6 
NOT COMPLETED   4 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Nicotrol Inhaler With Behavioral Counseling Nicotrol Inhaler: 10 mg of nicotine per one inhaler cartridge. Inhaler use will substitute the usual smoking pattern

Baseline Measures
   Nicotrol Inhaler With Behavioral Counseling 
Overall Participants Analyzed 
[Units: Participants]
 8 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      8 100.0% 
>=65 years      0   0.0% 
Age 
[Units: Years]
Mean (Full Range)
 26 
 (19 to 38) 
Gender 
[Units: Participants]
Count of Participants
 
Female      8 100.0% 
Male      0   0.0% 
Region of Enrollment 
[Units: Participants]
 
United States   8 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Days of Inhaler Use   [ Time Frame: Baseline to 4 weeks ]

2.  Secondary:   Cartridge Use   [ Time Frame: Baseline to 4 weeks ]

3.  Secondary:   Change in Number of Cigarettes Used Per Day From Baseline to 4 Weeks.   [ Time Frame: Baseline to 4 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Cheryl Oncken
Organization: UConn Health
phone: 860-679-3425
e-mail: oncken@uchc.edu



Responsible Party: Hartford Hospital
ClinicalTrials.gov Identifier: NCT00888979     History of Changes
Other Study ID Numbers: ONCK002885HU
H09-183-2 ( Other Identifier: Hartford Hospital )
Study First Received: April 24, 2009
Results First Received: July 10, 2015
Last Updated: November 10, 2016