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
研究概览
详细说明
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.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
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Virginia
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Richmond、Virginia、美国、23298 0205
- Behavioral Pharmacolgy Research Laboratory
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 介入模型:交叉作业
- 屏蔽:双倍的
研究衡量的是什么?
主要结果指标
结果测量 |
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主观影响
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认知表现
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生理措施
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吸烟行为
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Plasma Nicotine
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合作者和调查者
调查人员
- 首席研究员:Thomas Eissenberg, Ph.D.、Virginia Commonwealth University
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
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