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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
  Purpose

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 Intervention
Tobacco Use Disorder
Drug: nicotine transdermal system

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Effects of Transdermal Nicotine on Tobacco Withdrawal and the Effects of Smoking in Men and Women

Resource links provided by NLM:


Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • Subjective effects
  • Cognitive performance
  • Physiologic measures
  • Smoking Behavior
  • Plasma Nicotine

Estimated Enrollment: 128
Study Start Date: May 2004
Study Completion Date: June 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00135746

Locations
United States, Virginia
Behavioral Pharmacolgy Research Laboratory
Richmond, Virginia, United States, 23298 0205
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
Principal Investigator: Thomas Eissenberg, Ph.D. Virginia Commonwealth University
  More Information

No publications provided

Responsible Party: Thomas Eissenberg, Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT00135746     History of Changes
Other Study ID Numbers: NIDA-11082-2, R01-11082-2, DPMC
Study First Received: August 23, 2005
Last Updated: July 21, 2008
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on November 25, 2014