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Internet-Administered Smoking Cessation Treatment for Overweight and Obese Smokers

This study has been completed.
Sponsor:
Collaborator:
American Heart Association
Information provided by (Responsible Party):
Marney A. White, Yale University
ClinicalTrials.gov Identifier:
NCT01259466
First received: November 11, 2010
Last updated: August 27, 2015
Last verified: August 2015
Results First Received: July 16, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Smoking Cessation
Overweight
Obesity
Intervention: Drug: Nicotine patch

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Cognitive Behavioral Treatment + Nicotine Replacement Nicotine patch: Transdermal Nicotine Replacement Therapy - 21 mg daily for 10 weeks
Health Education + Nicotine Replacement Nicotine patch: Transdermal Nicotine Replacement Therapy - 21 mg daily for 10 weeks

Participant Flow:   Overall Study
    Cognitive Behavioral Treatment + Nicotine Replacement     Health Education + Nicotine Replacement  
STARTED     27     27  
COMPLETED     26     18  
NOT COMPLETED     1     9  
Withdrawal by Subject                 1                 9  



  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
Cognitive Behavioral Treatment + Nicotine Replacement Nicotine patch: Transdermal Nicotine Replacement Therapy - 21 mg daily for 10 weeks
Health Education + Nicotine Replacement Nicotine patch: Transdermal Nicotine Replacement Therapy - 21 mg daily for 10 weeks
Total Total of all reporting groups

Baseline Measures
    Cognitive Behavioral Treatment + Nicotine Replacement     Health Education + Nicotine Replacement     Total  
Number of Participants  
[units: participants]
  27     27     54  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     27     27     54  
>=65 years     0     0     0  
Age  
[units: years]
Mean (Standard Deviation)
  46.4  (11.6)     45.4  (9.6)     45.9  (10.5)  
Gender  
[units: participants]
     
Female     20     19     39  
Male     7     8     15  
Region of Enrollment  
[units: participants]
     
United States     27     27     54  



  Outcome Measures
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1.  Primary:   Number of Participants With Verified Smoking Cessation (Abstinence)   [ Time Frame: Post-treatment (12-weeks) ]

2.  Secondary:   Percent Weight Change   [ Time Frame: Post-treatment (12 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: Dr. Marney A. White
Organization: Yale University School of Medicine
phone: 203-785-4349
e-mail: marney.white@yale.edu



Responsible Party: Marney A. White, Yale University
ClinicalTrials.gov Identifier: NCT01259466     History of Changes
Other Study ID Numbers: 1001006181
Study First Received: November 11, 2010
Results First Received: July 16, 2015
Last Updated: August 27, 2015
Health Authority: United States: Institutional Review Board