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临床试验/NCT00390559
NCT00390559已完成不适用

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

Virginia Commonwealth University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2005年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
1
主要终点
Subjective Effects

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 in the effectiveness of nicotine replacement therapy. In addition, the purpose of this study is to determine whether men and women differ in their response to smoking-related stimuli (e.g., taste or smell of a lit cigarette). Conclusions drawn from this study may help to improve 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, suc has the taste, sight, or smell of cigarette smoke. Tailoring treatments to the separate needs of smoker subgroups , such as men and women, my produce better cessation outcomes. The purpose of this study is to assess whether men and women differ in the their response to NRT (i.e., transdermal nicotine) and smoking-related stimuli.

Participants in this double-blind, dose-comparison study will complete separate sessions in random order.

Each session will last approximately 6.5 hours and will correspond to a transdermal patch dose (0 or 21mg) and cigarette type (denicotinized and nicotinized). Objectively verified cigarette abstinence will be required before each session. Sessions will occur at least 48 hours apart to avoid carryover. At the beginning of each session a patch will be placed on the participant's back and at 4, 5, and 6 hours after patch application the participant will smoke a cigarette (all identifying marking on the cigarette will be covered for blinding purposes). Physiological, subjective, cognitive, and smoking behavior outcomes will be collected during study visits.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Double (Participant, Outcomes Assessor)

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

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

ActiveP/ActiveC

Experimental

21 mg patch/Nicotine-containing cigarette

干预措施: Nicotine transdermal system (Drug)

ActiveP/ActiveC

Experimental

21 mg patch/Nicotine-containing cigarette

干预措施: Nicotine containing cigarette (Other)

PlaceboP/ActiveC

Experimental

0 mg patch/nicotine-containing cigarette

干预措施: Nicotine transdermal system (Drug)

PlaceboP/ActiveC

Experimental

0 mg patch/nicotine-containing cigarette

干预措施: Nicotine containing cigarette (Other)

Active P/PlaceboC

Experimental

21 mg patch/no nicotine cigarette

干预措施: Nicotine transdermal system (Drug)

Active P/PlaceboC

Experimental

21 mg patch/no nicotine cigarette

干预措施: Placebo cigarette (Other)

PlaceboP/PlaceboC

Experimental

0 mg patch/no nicotine cigarette

干预措施: Nicotine transdermal system (Drug)

PlaceboP/PlaceboC

Experimental

0 mg patch/no nicotine cigarette

干预措施: Placebo cigarette (Other)

结局指标

主要结局

Subjective Effects

时间窗: 6 hours

The full scale name is the "Urge to smoke" visual analog scale (VAS). It measures self-reported "urge to smoke". As with any VAS a word or phrase (in this case, "Urge to Smoke" is centered over a horizontal line anchored on the left by "not at all" and on the right by "extremely." In this study, participants used a mouse to produce a vertical mark on the horizontal line, and the score was the distance of the mark from the left anchor expressed as a percentage of total line length. Thus, the minimum was 0 ("not at all") and the maximum score was 100 ("extremely").

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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