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

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ClinicalTrials.gov Identifier: NCT00390559
Recruitment Status : Completed
First Posted : October 20, 2006
Results First Posted : July 18, 2012
Last Update Posted : July 18, 2012
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Virginia Commonwealth University

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, 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
Enrollment 80

Recruitment Details Recruitment via media advertisement and flyer. Recruitment began 9/14/2005 and ended 1/30/2008.
Pre-assignment Details 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.
Arm/Group Title All Participants
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 124
Received PlaceboP/Active C 93
ActiveP/ActiveC 87
PlaceboP/PlaceboC 93
ActiveP/PlaceboC 90
Completed 80
Not Completed 44
Arm/Group Title All Participants
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 124
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 124 participants
<=18 years
0
   0.0%
Between 18 and 65 years
124
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 124 participants
Female
42
  33.9%
Male
82
  66.1%
1.Primary Outcome
Title Subjective Effects
Hide Description The full scale name is the "Urge to smoke" visual analog scale (VAS). It measures self-reported "urge to smoke". As with any VAS a word or phrase (in this case, "Urge to Smoke" is centered over a horizontal line anchored on the left by “not at all” and on the right by “extremely.” In this study, participants used a mouse to produce a vertical mark on the horizontal line, and the score was the distance of the mark from the left anchor expressed as a percentage of total line length. Thus, the minimum was 0 (“not at all”) and the maximum score was 100 (“extremely”).
Time Frame 6 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Those who completed all four "arms" of the crossover study.
Arm/Group Title ActiveP/ActiveC PlaceboP/ActiveC Active P/PlaceboC PlaceboP/PlaceboC
Hide Arm/Group Description:
21 mg patch/Nicotine-containing cigarette
0 mg patch/nicotine-containing cigarette
21 mg patch/no nicotine cigarette
0 mg patch/no nicotine cigarette
Overall Number of Participants Analyzed 80 80 80 80
Mean (Standard Deviation)
Unit of Measure: units on a scale
18.8  (24.7) 23.1  (24.5) 25.6  (28.8) 24.2  (25.8)
Time Frame 6 hours
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title ActiveP/ActiveC PlaceboP/ActiveC Active P/PlaceboC PlaceboP/PlaceboC
Hide Arm/Group Description 21 mg patch/Nicotine-containing cigarette 0 mg patch/nicotine-containing cigarette 21 mg patch/no nicotine cigarette 0 mg patch/no nicotine cigarette
All-Cause Mortality
ActiveP/ActiveC PlaceboP/ActiveC Active P/PlaceboC PlaceboP/PlaceboC
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
ActiveP/ActiveC PlaceboP/ActiveC Active P/PlaceboC PlaceboP/PlaceboC
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/80 (0.00%)   0/80 (0.00%)   0/80 (0.00%)   0/80 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
ActiveP/ActiveC PlaceboP/ActiveC Active P/PlaceboC PlaceboP/PlaceboC
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/80 (0.00%)   0/80 (0.00%)   0/80 (0.00%)   0/80 (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: Thomas Eissenberg
Organization: Virginia Commonwealth University
Phone: 804.827.4617
Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT00390559     History of Changes
Other Study ID Numbers: NIDA-11082-3
R01DA011082 ( U.S. NIH Grant/Contract )
R01-11082-3 DPMC
First Submitted: October 18, 2006
First Posted: October 20, 2006
Results First Submitted: November 10, 2011
Results First Posted: July 18, 2012
Last Update Posted: July 18, 2012