Prazosin as a Novel Treatment for Smoking Cessation
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
- 是
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
干预措施: Placebo (Drug)
Prazosin pills
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
Christian Hendershot
Independent Scientist
Centre for Addiction and Mental Health
