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临床试验/NCT00770237
NCT00770237已完成不适用

Effects of Smoking Cues on Tobacco Craving Responses and the Reinforcing Efficacy of Cigarettes in Smokers With and Without Schizophrenia

University of Maryland, Baltimore2 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2008年10月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
44
试验地点
2
主要终点
To compare the effects of smoking versus neutral cues on craving, mood, and autonomic responsivity in smokers with schizophrenia and smokers without schizophrenia.

研究概览

简要总结

In this study, we will compare cue-reactivity in smokers with and without schizophrenia and the influence of smoking cues on responding for cigarette puffs under a PR schedule of reinforcement. Given the high prevalence of smoking among individuals with schizophrenia, understanding some of the environmental factors that serve to maintain nicotine dependence is a critical step in improving smoking cessation treatment outcomes. Establishing and validating a laboratory model of cue-elicited responsivity and cigarette self- administration will allow the investigation of the efficacy of anti-craving medications in people with schizophrenia.

Specific Aims 1) To compare the effects of smoking versus neutral cues on craving, mood, and autonomic responsivity in smokers with schizophrenia and smokers without schizophrenia. 2) To compare the effects of smoking versus neutral cues on the reinforcing efficacy of tobacco cigarettes in smokers with schizophrenia and smokers without schizophrenia.

Outcome Measures During cue trials, primary measures include craving (TCQ-SF, VAS), mood (mood form, VAS), and autonomic (heart rate, blood pressure, skin conductance and temperature) responsivity. During self-administration trials, primary measures include breakpoint (final ratio completed), total number of responses, and number of cigarette puffs earned and taken. Secondary measures include baseline smoking history, mood form, TCQ-SF, CO, FTND, and urinary cotinine and 3-hydroxycotinine (3-HC).

The ratio of 3-HC/cotinine is a phenotypic biomarker of the rate of nicotine metabolism, which has been shown to be associated with level of nicotine dependence, various smoking behaviors, and treatment outcome (Ho & Tyndale, 2007). We will correlate the primary measures with the 3-HC/cotinine ratio to explore possible relationships for future study.

研究设计

研究类型
Interventional
干预模型
Crossover
主要目的
Diagnostic
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 64 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

Cues

Experimental

Outcome Measures During cue trials, primary measures include craving (TCQ-SF, VAS), mood (mood form, VAS), and autonomic (heart rate, blood pressure, skin conductance and temperature) responsivity. During self-administration trials, primary measures include breakpoint (final ratio completed), total number of responses, and number of cigarette puffs earned and taken. Secondary measures include baseline smoking history, mood form, TCQ-SF, CO, FTND, and urinary cotinine and 3-hydroxycotinine (3-HC).

干预措施: Smoking Cues (Behavioral)

Cues

Experimental

Outcome Measures During cue trials, primary measures include craving (TCQ-SF, VAS), mood (mood form, VAS), and autonomic (heart rate, blood pressure, skin conductance and temperature) responsivity. During self-administration trials, primary measures include breakpoint (final ratio completed), total number of responses, and number of cigarette puffs earned and taken. Secondary measures include baseline smoking history, mood form, TCQ-SF, CO, FTND, and urinary cotinine and 3-hydroxycotinine (3-HC).

干预措施: Neutral Cues (Behavioral)

结局指标

主要结局

To compare the effects of smoking versus neutral cues on craving, mood, and autonomic responsivity in smokers with schizophrenia and smokers without schizophrenia.

时间窗: 7-10 Days

次要结局

未报告次要终点

研究者

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

MPRC

Deanna L. Kelly, Pharm.D., BCPP

University of Maryland, Baltimore

研究点 (2)

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