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Examining the Effect of the Nicotine Patch in Male and Female Smokers - 3

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT00390559
First received: October 18, 2006
Last updated: July 6, 2012
Last verified: July 2012
Results First Received: November 10, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Pharmacodynamics Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Outcomes Assessor);   Primary Purpose: Basic Science
Conditions: Drug Addiction
Smoking Cessation
Interventions: Drug: nicotine transdermal system
Drug: Nicotine transdermal system
Other: Nicotine containing cigarette
Other: Placebo cigarette

  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
Recruitment via media advertisement and flyer. Recruitment began 9/14/2005 and ended 1/30/2008.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Enrolled (i.e., consented) participants were excluded if they failed to meet safety criteria (e.g., blood pressure) measured after the informed consent was given.

Reporting Groups
  Description
All Participants In this study, overnight abstinent smokers completed four, double-blind laboratory sessions corresponding to a 2x2 design where transdermal nicotine dose (TN, 0 or 21 mg) was crossed with type of cigarette (nicotine-containing [NIC] or not [DENIC]). Cigarettes were smoked 4 hours after TN administration.

Participant Flow:   Overall Study
    All Participants  
STARTED     124  
Received PlaceboP/Active C     93  
ActiveP/ActiveC     87  
PlaceboP/PlaceboC     93  
ActiveP/PlaceboC     90  
COMPLETED     80  
NOT COMPLETED     44  



  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.
No text entered.

Reporting Groups
  Description
All Participants In this study, overnight abstinent smokers completed four, double-blind laboratory sessions corresponding to a 2x2 design where transdermal nicotine dose (TN, 0 or 21 mg) was crossed with type of cigarette (nicotine-containing [NIC] or not [DENIC]). Cigarettes were smoked 4 hours after TN administration.

Baseline Measures
    All Participants  
Number of Participants  
[units: participants]
  124  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     124  
>=65 years     0  
Gender  
[units: participants]
 
Female     42  
Male     82  



  Outcome Measures

1.  Primary:   Subjective Effects   [ Time Frame: 6 hours ]


  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
No text entered.


  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: Thomas Eissenberg
Organization: Virginia Commonwealth University
phone: 804.827.4617
e-mail: teissenb@vcu.edu


No publications provided


Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT00390559     History of Changes
Other Study ID Numbers: NIDA-11082-3, R01DA011082, R01-11082-3 DPMC
Study First Received: October 18, 2006
Results First Received: November 10, 2011
Last Updated: July 6, 2012
Health Authority: United States: Federal Government