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临床试验/NCT01214005
NCT01214005已完成2 期

Smoking Abstinence and Lapse Effects in Smokers With Schizophrenia and Controls

Brown University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2009年6月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
60
试验地点
2
主要终点
Withdrawal symptoms

研究概览

简要总结

This project tests two hypotheses concerning the low smoking cessation rates in smokers with schizophrenia. The first hypothesis is that smokers with schizophrenia experience stronger and more sustained effects of smoking abstinence on negative mood and smoking urge than control smokers without psychiatric illness. The second hypothesis is that smokers with schizophrenia experience stronger reinforcing effects of a smoking lapse (i.e., more rewarding effects of smoking after a period of abstinence) than control smokers without psychiatric illness.

详细描述

In this study, smokers with schizophrenia and smokers without psychiatric illness participate in a nicotine preference task before and after a 3-day period of continuous smoking abstinence. The investigators will experimentally control abstinence by providing participants with high-value cash incentives contingent upon smoking abstinence verified with breath carbon monoxide levels. The investigators will measure nicotine withdrawal and smoking urge during the abstinence period. In the nicotine preference task, participants will make choices between nicotine-containing and denicotinized cigarette puffs to provide a measure of nicotine reinforcement, and the investigators will also measure the effects of smoking on mood. After the second nicotine preference task, participants will receive a small-value reinforcer if they continue to abstain for another day, and the investigators will measure time to the second lapse.

研究设计

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

入排标准

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

入选标准

  • cigarette smokers, 20-50 cigarettes per day
  • schizophrenia or no psychiatric illness
  • age 18 or older
  • male or female

排除标准

  • unstable symptoms or medication
  • not interested in quitting smoking within 6 months

结局指标

主要结局

Withdrawal symptoms

时间窗: 3 days

negative mood related to nicotine withdrawal

positive and negative mood

时间窗: before and after 3 days of abstinence

positive and negative mood scale

urge to smoke

时间窗: 3 days

craving for smoking

nicotine preference

时间窗: before and after 3 days of abstinence

choice for nicotine puffs versus denicotinized cigarette puffs

次要结局

  • time to lapse(192 hours)

研究者

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

Jennifer Tidey

Associate Professor (Research)

Brown University

研究点 (2)

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