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临床试验/NCT00289653
NCT00289653已完成不适用

Smoking While on Transdermal Nicotine Replacement Therapy: Effects on Craving and Cessation

Centre for Addiction and Mental Health1 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2005年9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
23
试验地点
1
主要终点
Carbon Monoxide Levels

研究概览

简要总结

Smoking while on nicotine patches will help subjects to reduce their expired carbon monoxide levels from the levels they were before they started using the patch. Subjects will also decrease their daily consumption of cigarettes.

详细描述

Subjects who smoke while on an individually dosed tNRT will reduce their expired carbon monoxide levels from pre- to post-treatment conditions. They will also decrease their daily consumption of cigarettes.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • at least 19 years of age
  • male or female
  • have intention to quit smoking within the next 6 months
  • smoke 10 or more cigarettes per day

排除标准

  • Pregnant or not using an adequate enough method of birth control to ensure that they are not at risk of becoming pregnant
  • breastfeeding
  • have any generalized skin disorders
  • are in an immediate post-myocardial infarction period or have life-threatening arrhythmias, have severe or worsening angina pectoris or have had a recent cerebral vascular accident
  • are using additional nicotine replacement therapies or any other smoking cessation pharmacotherapy
  • any clinically significant ECG abnormalities
  • any known hypersensitivity to components of the transdermal system

研究组 & 干预措施

single open-label treatment arm

Experimental

Adult smokers willing to quit were treated with escalating doses of transdermal nicotine patch (Nicoderm) and brief counselling if they continued to smoke over a 9-week treatment period.

干预措施: Nicoderm (Drug)

结局指标

主要结局

Carbon Monoxide Levels

时间窗: measured at week 10

Expired Co levels were measured to confirm smoking status

次要结局

  • Smoking Cessation(Week 10)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Peter Selby

Dr. P. Selby

Centre for Addiction and Mental Health

研究点 (1)

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