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临床试验/NCT00135746
NCT00135746已完成不适用

Effects of Transdermal Nicotine on Tobacco Withdrawal and the Effects of Smoking in Men and Women

National Institute on Drug Abuse (NIDA)2 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2004年5月最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
128
试验地点
2
主要终点
Cognitive performance

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
干预模型
Crossover
主要目的
Treatment
盲法
Double

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Cognitive performance

Smoking Behavior

Subjective effects

Physiologic measures

Plasma Nicotine

次要结局

未报告次要终点

研究者

申办方类型
Nih

研究点 (2)

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