Ability of Partial Inverse Agonist, Iomazenil, to Block Ethanol Effects in Humans
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Biphasic Ethanol Effects Scale (BAES)
研究概览
简要总结
Alcohol is abused commonly, but there is no remedy for alcohol intoxication. This project is looking at the substance iomazenil and its effect on alcohol intoxication and alcohol's effects on driving using a driving simulator.
详细描述
Alcohol is abused commonly, but there is no antidote for alcohol intoxication the way naltrexone or naloxone is an antidote for opioids. A medication that has the potential to block alcohol actions in the Central Nervous System could act as a unique medication in the treatment of alcohol intoxication and alcoholism. This project is evaluating the benzodiazepine partial inverse agonist, iomazenil, as an agent that could reverse alcohol's effects on subjective intoxication, alcohol's effects on driving using a driving simulator and on measures of electrophysiology in the laboratory in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 35 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •21-35 years old
- •Medically healthy
排除标准
- •Under the age of 21 or greater than the age 35
- •History of seizures
研究组 & 干预措施
Active Ethanol and Active Iomazenil
Participants will receive in a randomized, double-blind, cross-over design, ethanol or placebo and iomazenil or placebo.
Potential Randomizations: a) active ethanol and placebo iomazenil, b) active ethanol and active iomazenil, c) placebo ethanol and active iomazenil, and d) placebo ethanol and placebo iomazenil
干预措施: Active Ethanol (Drug)
Active Ethanol and Active Iomazenil
Participants will receive in a randomized, double-blind, cross-over design, ethanol or placebo and iomazenil or placebo.
Potential Randomizations: a) active ethanol and placebo iomazenil, b) active ethanol and active iomazenil, c) placebo ethanol and active iomazenil, and d) placebo ethanol and placebo iomazenil
干预措施: Active Iomazenil (Drug)
Active Ethanol and Placebo Iomazenil
Participants will receive in a randomized, double-blind, cross-over design, ethanol or placebo and iomazenil or placebo.
Potential Randomizations: a) active ethanol and placebo iomazenil, b) active ethanol and active iomazenil, c) placebo ethanol and active iomazenil, and d) placebo ethanol and placebo iomazenil
干预措施: Active Ethanol (Drug)
Active Ethanol and Placebo Iomazenil
Participants will receive in a randomized, double-blind, cross-over design, ethanol or placebo and iomazenil or placebo.
Potential Randomizations: a) active ethanol and placebo iomazenil, b) active ethanol and active iomazenil, c) placebo ethanol and active iomazenil, and d) placebo ethanol and placebo iomazenil
干预措施: Placebo (Drug)
Placebo Ethanol and Active Iomazenil
Participants will receive in a randomized, double-blind, cross-over design, ethanol or placebo and iomazenil or placebo.
Potential Randomizations: a) active ethanol and placebo iomazenil, b) active ethanol and active iomazenil, c) placebo ethanol and active iomazenil, and d) placebo ethanol and placebo iomazenil
干预措施: Active Iomazenil (Drug)
Placebo Ethanol and Active Iomazenil
Participants will receive in a randomized, double-blind, cross-over design, ethanol or placebo and iomazenil or placebo.
Potential Randomizations: a) active ethanol and placebo iomazenil, b) active ethanol and active iomazenil, c) placebo ethanol and active iomazenil, and d) placebo ethanol and placebo iomazenil
干预措施: Placebo (Drug)
Placebo Ethanol and Placebo Iomazenil
Participants will receive in a randomized, double-blind, cross-over design, ethanol or placebo and iomazenil or placebo.
Potential Randomizations: a) active ethanol and placebo iomazenil, b) active ethanol and active iomazenil, c) placebo ethanol and active iomazenil, and d) placebo ethanol and placebo iomazenil
干预措施: Placebo (Drug)
结局指标
主要结局
Biphasic Ethanol Effects Scale (BAES)
时间窗: Administered 160 mins and 10 mins prior to the target ethanol/placebo dose being reached, when the target ethanol dose (BrAC of 0.1%)/placebo has been reached, and 15, 70, 90, 150, and 240 minutes after the target ethanol/placebo dose has been reached.
A 14-item scale with 7 items designated to assess stimulant effects associated with the ascending limb of ethanol intoxication and 7 items developed to measure sedative effects associated with the descending limb of ethanol intoxication. The BAES full scale would be 0 to 140. However, the scale itself is analyzed by breaking up the full 14 item scale into 2 parts - sedation and stimulation. Therefore, the total score for sedation ranges from 0 to 70, with higher scores indicating more sedation, and the total score for stimulation also ranges from 0 to 70, with higher scores indicating more stimulation. Timepoints: Administered 160 mins (M160) and 10 mins (M10) prior to the target ethanol/placebo dose being reached, when the target ethanol dose (BrAC of 0.1%)/placebo has been reached (0), and 15 (P15), 70 (P70), 90 (P90), and 150 (P150) minutes after the target ethanol/placebo dose has been reached.
次要结局
未报告次要终点