Alprazolam and Simulated Driving Performance: Next Day Effects
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Standard Deviation of Lane Position (SLDP)
研究概览
简要总结
This study evaluates the effect of anxiety drugs taken at night on the ability to drive a car the next day. Participants will receive alprazolam, placebo, or zolpidem at night before bed or in the morning before using a driving simulator to assess impairment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
盲法说明
Participants and outcomes assessors were masked with respect to each individual intervention.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •valid driver's license
- •english-speaking and literate
排除标准
- •using daily medication for chronic condition
- •acute narrow angle glaucoma
- •previous adverse experience with study drugs
- •experiences motion sickness in response to driving simulator
- •BMI > 30
- •women who are pregnant, lactating, or planning on becoming pregnant
- •regular use of tobacco products
- •current substance use disorder
- •clinically significant ECG
- •current ongoing psychiatric disorder
研究组 & 干预措施
All Participants
All participants received each intervention with alprazolam, zolpidem and placebo.
干预措施: Alprazolam 2mg (2ALP/PLC) (Drug)
All Participants
All participants received each intervention with alprazolam, zolpidem and placebo.
干预措施: Alprazolam 1mg (1ALP/PLC) (Drug)
All Participants
All participants received each intervention with alprazolam, zolpidem and placebo.
干预措施: Alprazolam 0.5mg (0.5ALP/PLC) (Drug)
All Participants
All participants received each intervention with alprazolam, zolpidem and placebo.
干预措施: Zolpidem 10mg (ZOL/PLC) (Drug)
All Participants
All participants received each intervention with alprazolam, zolpidem and placebo.
干预措施: Placebo (PLC/PLC) (Drug)
All Participants
All participants received each intervention with alprazolam, zolpidem and placebo.
干预措施: Alprazolam 1mg (PLC/ALC) (Drug)
结局指标
主要结局
Standard Deviation of Lane Position (SLDP)
时间窗: 16 hours
Lane deviation (swerving) on a driving simulator. This is measured as the distance (cm) the driver deviates from the lane.
次要结局
未报告次要终点
研究者
Marion Coe
Doctoral Candidate
University of Kentucky