Examining the Effectiveness of the Nicotine Patch in Male and Female Smokers - 2

This study has been completed.
Sponsor:
Collaborator:
Virginia Commonwealth University
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00135746
First received: August 23, 2005
Last updated: July 21, 2008
Last verified: July 2008

August 23, 2005
July 21, 2008
May 2004
May 2007   (final data collection date for primary outcome measure)
  • Subjective effects
  • Cognitive performance
  • Physiologic measures
  • Smoking Behavior
  • Plasma Nicotine
Same as current
Complete list of historical versions of study NCT00135746 on ClinicalTrials.gov Archive Site
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Examining the Effectiveness of the Nicotine Patch in Male and Female Smokers - 2
Effects of Transdermal Nicotine on Tobacco Withdrawal and the Effects of Smoking 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 on the effectiveness of nicotine replacement therapy. This may lead to improved 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, such as the taste, sight, and smell of smoke. Tailoring treatment to the separate needs of subgroups, such as men and women, may produce better outcomes. The purpose of this study is to assess the influence of gender on the effectiveness of transdermal nicotine treatment in a group of male and female smokers.

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

Each session will last approximately 6.5 hours and will correspond to a specific transdermal patch dose (0, 7, 14, or 21 mg). Objectively verified cigarette abstinence will be required before each session. Sessions will occur at least 48 hours apart to avoid carryover. Cognitive, behavioral, subjective, and physiological measures will occur during study visits. Specifically, the NRT dose response to tobacco suppression and cigarette blunting effects will be compared in women and men.

Interventional
Not Provided
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Tobacco Use Disorder
Drug: nicotine transdermal system
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
128
June 2007
May 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Daily cigarette use of 15 or more cigarettes for at least 2 years
  • Screening CO level of or greater than 15 ppm
  • Normal or corrected-to-normal vision
  • Willing to abstain from tobacco products for 8 or more hours prior to testing

Exclusion Criteria:

  • 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
 
NCT00135746
NIDA-11082-2, R01-11082-2, DPMC
Not Provided
Thomas Eissenberg, Virginia Commonwealth University
National Institute on Drug Abuse (NIDA)
Virginia Commonwealth University
Principal Investigator: Thomas Eissenberg, Ph.D. Virginia Commonwealth University
National Institute on Drug Abuse (NIDA)
July 2008

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