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

October 18, 2006
July 6, 2012
October 2005
March 2008   (final data collection date for primary outcome measure)
Subjective Effects [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
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").
  • Subjective effects
  • Cognitive performance
  • Heart Rate
  • Expired Air Carbon Monoxide Level
  • Plasma Nicotine
  • Smoking Behavior
Complete list of historical versions of study NCT00390559 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Examining the Effect of the Nicotine Patch in Male and Female Smokers - 3
Effects of Transdermal Nicotine on Tobacco Withdrawal and the Effects of Smoking-related Stimuli in Men and Women

Treatment studies have demonstrated that current smoking cessation techniques are less effective for women. The purpose of this study is to determine the role that gender plays in the effectiveness of nicotine replacement therapy. In addition, the purpose of this study is to determine whether men and women differ in their response to smoking-related stimuli (e.g., taste or smell of a lit cigarette). Conclusions drawn from this study may help to improve cessation interventions for all smokers, particularly women.

Currently,about 70 percent of smokers who try to quit by using smoking cessation treatments are unsuccessful. Treatment studies have demonstrated that current smoking cessation techniques are less effective for women. There is no clear explanation for this difference, but it may involve a differential response to nicotine replacement treatments (NRTs) and/or smoking-related stimuli. For women, NRT may be less effective at suppressing withdrawal or blunting the effects of smoking during a quit attempt. Women may also be more sensitive to smoking-related stimuli, suc has the taste, sight, or smell of cigarette smoke. Tailoring treatments to the separate needs of smoker subgroups , such as men and women, my produce better cessation outcomes. The purpose of this study is to assess whether men and women differ in the their response to NRT (i.e., transdermal nicotine) and smoking-related stimuli.

Participants in this double-blind, dose-comparison study will complete separate sessions in random order.

Each session will last approximately 6.5 hours and will correspond to a transdermal patch dose (0 or 21mg) and cigarette type (denicotinized and nicotinized). Objectively verified cigarette abstinence will be required before each session. Sessions will occur at least 48 hours apart to avoid carryover. At the beginning of each session a patch will be placed on the participant's back and at 4, 5, and 6 hours after patch application the participant will smoke a cigarette (all identifying marking on the cigarette will be covered for blinding purposes). Physiological, subjective, cognitive, and smoking behavior outcomes will be collected during study visits.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Basic Science
  • Drug Addiction
  • Smoking Cessation
  • Drug: nicotine transdermal system
    21 mg nicotine transdermal system
    Other Name: Nicoderm CQ
  • Drug: Nicotine transdermal system
    Placebo nicotine patch
  • Other: Nicotine containing cigarette
    Nicotine containing cigarette
  • Other: Placebo cigarette
    Non nicotine containing cigarette
  • Experimental: ActiveP/ActiveC
    21 mg patch/Nicotine-containing cigarette
    Interventions:
    • Drug: nicotine transdermal system
    • Other: Nicotine containing cigarette
  • Experimental: PlaceboP/ActiveC
    0 mg patch/nicotine-containing cigarette
    Interventions:
    • Drug: Nicotine transdermal system
    • Other: Nicotine containing cigarette
  • Experimental: Active P/PlaceboC
    21 mg patch/no nicotine cigarette
    Interventions:
    • Drug: nicotine transdermal system
    • Other: Placebo cigarette
  • Experimental: PlaceboP/PlaceboC
    0 mg patch/no nicotine cigarette
    Interventions:
    • Drug: Nicotine transdermal system
    • Other: Placebo cigarette
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
March 2008
March 2008   (final data collection date for primary outcome measure)

Inclusion Criteria include, but are not limited to:

18-50 years of age Smokes 15 cigarettes/day for at least 2 years Healthy (as determined by a brief study physical with medical doctor) Displays understanding of cognitive tasks.

Exclusion Criteria include, but are not limited to:

History of chronic health problems or psychiatric conditions History of cardiovascular disease, low or high blood pressure, seizures, head injuries requiring hospital care, peptic ulcer, or diabetes Pregnancy (tested by urinalysis) Scores greater than 17 on the Beck Depression Inventory Lack of a high school degree or GED

Both
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00390559
NIDA-11082-3, R01DA011082, R01-11082-3 DPMC
No
Virginia Commonwealth University
Virginia Commonwealth University
National Institute on Drug Abuse (NIDA)
Principal Investigator: Thomas E Eissenberg, PhD Virginia Commonwealth University Department of Psychology, Institute for Drug and Alcohol Studies
Virginia Commonwealth University
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP