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临床试验/NCT01642433
NCT01642433终止2 期

Prazosin as a Novel Treatment for Smoking Cessation

Centre for Addiction and Mental Health1 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2012年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
终止
入组人数
1
试验地点
1
主要终点
Short-term smoking cessation

研究概览

简要总结

The most likely outcome of smoking cessation attempts is relapse, underscoring the need to advance novel treatments. Preclinical research shows that the noradrenergic system is critical for modulating drug-seeking behavior and recent findings indicate that the α1-adrenergic antagonist prazosin reduces nicotine self-administration and reinstatement. Presently, data on prazosin's effects on nicotine-related behaviour in humans is lacking. An efficient method for screening novel smoking cessation medications is to integrate human laboratory paradigms in the context of brief, randomized trials of smoking cessation that include smokers motivated to quit. This study aims to provide an initial test of prazosin for smoking cessation by implementing a brief, randomized trial that will include both human laboratory and clinical phenotypes. This approach will allow an efficient but sensitive method for medication screening that maximizes clinical validity.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Greater than or equal to 10 cigarettes per day for past year
  • Baseline Fagerstrom Test for Nicotine Dependence (FTND) score of greater than or equal to four
  • Willing to engage in two practice quit attempts
  • Willingness to forgo other medication based treatments during the trial

排除标准

  • Current illicit drug use
  • Current treatment with psychiatric medications other than selective serotonin re-uptake inhibitors (SSRIs)
  • Lifetime diagnosis of post-traumatic stress disorder (PTSD)
  • Significant medical/neurological illness
  • Baseline BP outside of normal range
  • Current use of tobacco aids
  • Current use of medications that could interact with prazosin
  • Pregnancy or nursing

研究组 & 干预措施

Sugar pills

Placebo Comparator

干预措施: Placebo (Drug)

Prazosin pills

Active Comparator

干预措施: Prazosin (Drug)

结局指标

主要结局

Short-term smoking cessation

时间窗: 4 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

Christian Hendershot

Independent Scientist

Centre for Addiction and Mental Health

研究点 (1)

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