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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
Enrollment 674

Recruitment Details Recruitment occurred between December 1999 and July 2003.
Pre-assignment Details  
Arm/Group Title Transdermal Nicotine Nicotine Nasal Spray
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 344 330
Completed 302 298
Not Completed 42 32
Arm/Group Title Transdermal Nicotine Nicotine Nasal Spray Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 344 330 674
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 344 participants 330 participants 674 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
329
  95.6%
321
  97.3%
650
  96.4%
>=65 years
15
   4.4%
9
   2.7%
24
   3.6%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 344 participants 330 participants 674 participants
45.63  (10.88) 45.41  (10.37) 45.53  (10.63)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 344 participants 330 participants 674 participants
Female
174
  50.6%
185
  56.1%
359
  53.3%
Male
170
  49.4%
145
  43.9%
315
  46.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 344 participants 330 participants 674 participants
344 330 674
1.Primary Outcome
Title Continuous Abstinence at End of Treatment (Self-report)(Defined as the Number of Consecutive Days Without Smoking a Cigarette for Each Subject)
Hide Description A self-report measure of continuous abstinence at end of treatment. It is defined as the number of consecutive days without smoking a cigarette for each subject, as determined by the Timeline Followback (TLFB), completed by research staff. The TLFB is an assessment tool that obtains estimates of daily smoking. Using a calendar, people provide retrospective estimates of their daily smoking over a specified time period that can vary up to 12 months from the interview date. The TLFB has also been used to assess other forms of substance abuse (e.g., alcohol, drugs, etc.).
Time Frame End of Treatment (8-weeks after quit date)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was intention to treat (ITT)
Arm/Group Title Transdermal Nicotine Nicotine Nasal Spray
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 344 330
Measure Type: Number
Unit of Measure: Participants
83 75
2.Secondary Outcome
Title Verified 7-day Point Prevalence Abstinence at End Of Treatment.
Hide Description

End-of-Treatment (EOT) is defined as the phone survey that takes place at the end of each subject's nicotine replacement therapy treatment. The EOT took place up to 8 weeks after participants began the study and also utilized the Timeline Followback. It is a 7-day point prevalence measure describing a subject's ability to remain abstinent from smoking for the 7 previous days occurring before a subject's EOT phone survey.

This was verified by a Carbon Monoxide breath reading taking place within a week of a subject's End of Treatment phone survey.

Time Frame End of Treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Transdermal Nicotine Nicotine Nasal Spray
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 344 330
Measure Type: Number
Unit of Measure: participants
112 95
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Transdermal Nicotine Nicotine Nasal Spray
Hide Arm/Group Description 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. 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.
All-Cause Mortality
Transdermal Nicotine Nicotine Nasal Spray
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Transdermal Nicotine Nicotine Nasal Spray
Affected / at Risk (%) Affected / at Risk (%)
Total   0/344 (0.00%)   0/330 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Transdermal Nicotine Nicotine Nasal Spray
Affected / at Risk (%) Affected / at Risk (%)
Total   0/344 (0.00%)   0/330 (0.00%) 
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
Publications of Results:
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