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Assessment of High Dose Transdermal Nicotine for Fast Metabolizers of Nicotine (HDP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Robert Schnoll, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00956943
First received: July 23, 2009
Last updated: February 14, 2013
Last verified: October 2012
History of Changes
Results First Received: January 14, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Factorial Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Nicotine Dependence
Interventions: Drug: Nicoderm CQ transdermal nicotine
Drug: placebo

  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
Media ads asked treatment-seeking smokers to call for information about a smoking cessation program and to have their initial eligibility reviewed. Participants interested in the clinical trial and initially eligible attended an in-person session to determine their final eligibility. Recruitment was from 2009-2011.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
To be eligible, participants had to be: between age 18 and 55, smoke >10 cigarettes/day, and able to communicate in English. In addition, participants had to have a 3-HC/cotinine ratio that placed them in the top 3 quartiles of the 3-HC/cotinine ratio distribution to be consider fast nicotine metabolizers, which was >.18.

Reporting Groups
  Description
21mg Transdermal Nicotine + Placebo Patch

21mg transdermal nicotine + placebo patch

Nicoderm CQ transdermal nicotine : Transdermal nicotine patch (21mg vs. 42mg), 8 weeks

placebo : placebo patch
42mg Transdermal Nicotine

42mg transdermal nicotine

Nicoderm CQ transdermal nicotine : Transdermal nicotine patch (21mg vs. 42mg), 8 weeks

Participant Flow:   Overall Study
    21mg Transdermal Nicotine + Placebo Patch     42mg Transdermal Nicotine  
STARTED     43     44  
Baseline     43     44  
COMPLETED     34     34  
NOT COMPLETED     9     10  
Lost to Follow-up                 9                 10  



  Baseline Characteristics
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Reporting Groups
  Description
21mg Transdermal Nicotine + Placebo Patch No text entered.
42mg Transdermal Nicotine No text entered.
Total Total of all reporting groups

Baseline Measures
    21mg Transdermal Nicotine + Placebo Patch     42mg Transdermal Nicotine     Total  
Number of Participants  
[units: participants]
 		  43     44     87  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     43     44     87  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation 		  37.1  ± 9.0     38.8  ± 9.0     38  ± 9  
Gender  
[units: participants]
 		     
Female     22     23     45  
Male     21     21     42  
Region of Enrollment  
[units: participants]
 		     
United States     43     44     87  



  Outcome Measures
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1.  Primary:   Biochemically Verified 7-day Point Prevalence Abstinence at the End of 8 Weeks of Treatment   [ Time Frame: After 8 weeks of treatment with the patch, outcome will be measured. ]
  Show Outcome Measure 1

2.  Secondary:   Side Effects   [ Time Frame: 8 weeks ]
  Show Outcome Measure 2


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
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
This was a proof of concept trial and, as such, was inadequately powered to detect statistically significant treatment arm effects and did not include a long-term follow-up assessment.  


Results Point of Contact:  
Name/Title: Robert A. Schnoll, Ph.D.
Organization: University of Pennsylvania
phone: 215-746-7143
e-mail: schnoll@mail.med.upenn.edu


No publications provided


Responsible Party: Robert Schnoll, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00956943     History of Changes
Other Study ID Numbers: 809716, R21DA026889
Study First Received: July 23, 2009
Results First Received: January 14, 2013
Last Updated: February 14, 2013
Health Authority: United States: Food and Drug Administration