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Trial record 1 of 1 for:    15007373 [PUBMED-IDS]
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Bio-Behavioral Predictors of the Efficacy of Nicotine Replacement Therapy (NRT)

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ClinicalTrials.gov Identifier: NCT00326781
Recruitment Status : Completed
First Posted : May 17, 2006
Results First Posted : March 19, 2010
Last Update Posted : August 24, 2010
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
University of Pennsylvania

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Smoking
Interventions: Drug: Nicoderm Transdermal Patch
Drug: Nicotine Nasal Spray

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment occurred between December 1999 and July 2003.

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
Transdermal Nicotine Half of randomized participants received 8-weeks of transdermal nicotine (Nicoderm CQ). The dosing schedule was as follows: 4 weeks of 21mg per 24 hours, 2 weeks of 14mg per 24 hours, and 2 weeks of 7mg per 24 hours.
Nicotine Nasal Spray Half of all participants received nicotine nasal spray. 8 weeks of self-administered nicotine nasal spray @ 40 recommended doses per day, tapering by 1/3 for the last 4 weeks. Nasal spray dosing was 0.5 mg spray per nostril (1 mg) for a maximum of 5 doses per hour and 40 doses per day. This dosing schedule is based on the average nicotine intake per cigarette of 1 mg per cigarette.

Participant Flow:   Overall Study
    Transdermal Nicotine   Nicotine Nasal Spray
STARTED   344   330 
COMPLETED   302   298 
NOT COMPLETED   42   32 



  Baseline Characteristics

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
Transdermal Nicotine Half of randomized participants received 8-weeks of transdermal nicotine (Nicoderm CQ). The dosing schedule was as follows: 4 weeks of 21mg per 24 hours, 2 weeks of 14mg per 24 hours, and 2 weeks of 7mg per 24 hours.
Nicotine Nasal Spray Half of all participants received nicotine nasal spray. 8 weeks of self-administered nicotine nasal spray @ 40 recommended doses per day, tapering by 1/3 for the last 4 weeks. Nasal spray dosing was 0.5 mg spray per nostril (1 mg) for a maximum of 5 doses per hour and 40 doses per day. This dosing schedule is based on the average nicotine intake per cigarette of 1 mg per cigarette.
Total Total of all reporting groups

Baseline Measures
   Transdermal Nicotine   Nicotine Nasal Spray   Total 
Overall Participants Analyzed 
[Units: Participants]
 344   330   674 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   329   321   650 
>=65 years   15   9   24 
Age 
[Units: Years]
Mean (Standard Deviation)
 45.63  (10.88)   45.41  (10.37)   45.53  (10.63) 
Gender 
[Units: Participants]
     
Female   174   185   359 
Male   170   145   315 
Region of Enrollment 
[Units: Participants]
     
United States   344   330   674 


  Outcome Measures

1.  Primary:   Continuous Abstinence at End of Treatment (Self-report)(Defined as the Number of Consecutive Days Without Smoking a Cigarette for Each Subject)   [ Time Frame: End of Treatment (8-weeks after quit date) ]

2.  Secondary:   Verified 7-day Point Prevalence Abstinence at End Of Treatment.   [ Time Frame: End of Treatment ]


  Serious Adverse Events


  Other Adverse Events


  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
No text entered.


  More Information

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: Caryn Lerman, Ph.D.
Organization: University of Pennsylvania
phone: 215-746-7141
e-mail: clerman@mail.med.upenn.edu


Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Caryn Lerman, Ph.D., University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00326781     History of Changes
Other Study ID Numbers: 703294
P50CA084718 ( U.S. NIH Grant/Contract )
First Submitted: May 15, 2006
First Posted: May 17, 2006
Results First Submitted: May 15, 2009
Results First Posted: March 19, 2010
Last Update Posted: August 24, 2010