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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00135746
Recruitment Status : Completed
First Posted : August 26, 2005
Last Update Posted : January 12, 2017
Virginia Commonwealth University
Information provided by:
National Institute on Drug Abuse (NIDA)

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Tobacco Use Disorder Drug: nicotine transdermal system Not Applicable

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Effects of Transdermal Nicotine on Tobacco Withdrawal and the Effects of Smoking in Men and Women
Study Start Date : May 2004
Actual Primary Completion Date : May 2007
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Subjective effects
  2. Cognitive performance
  3. Physiologic measures
  4. Smoking Behavior
  5. Plasma Nicotine

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00135746

United States, Virginia
Behavioral Pharmacolgy Research Laboratory
Richmond, Virginia, United States, 23298 0205
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
Virginia Commonwealth University
Principal Investigator: Thomas Eissenberg, Ph.D. Virginia Commonwealth University

Responsible Party: Thomas Eissenberg, Virginia Commonwealth University Identifier: NCT00135746     History of Changes
Other Study ID Numbers: NIDA-11082-2
First Posted: August 26, 2005    Key Record Dates
Last Update Posted: January 12, 2017
Last Verified: October 2015

Keywords provided by National Institute on Drug Abuse (NIDA):

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action