Examining the Effectiveness of the Nicotine Patch in Male and Female Smokers - 2
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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 |
- 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) |
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 |
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| United States, Virginia | |
| Behavioral Pharmacolgy Research Laboratory | |
| Richmond, Virginia, United States, 23298 0205 | |
| 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 Substance-Related Disorders Mental Disorders Nicotine Nicotine polacrilex Ganglionic Stimulants Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
Pharmacologic Actions Nicotinic Agonists Cholinergic Agonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Central Nervous System Stimulants Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 22, 2013