NL-OMON34124已完成不适用
A double-blind, randomized, three-way cross-over trial to develop a pharmacologic challenge with ketamine. - ketamine-challenge
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Age between 18 and 45 (extremes included)
- •Body Mass Index (BMI) between 18 and 30 kg/m2 (extremes included)
- •Mild cannabis users (defined as >= 4 times in last year and <= 1x/week in last year)
- •Willing to provide informed consent to participate in the study and to comply with all study procedures
排除标准
- •Clinically significant (history of) disease as determined by medical history, physical examination, ECG or routine blood chemistry, hematology or virology tests.
- •Clinically significant (history of) psychiatric illnesses (including substance abuse) or (history of) psychotic symptoms
- •Family history of relevant psychiatric disorders (first degree) and/or psychotic disorders (first and second degree)
- •Smokes more than five cigarettes a day
- •Positive urine drug screen for recreational drugs (i.e. cocaine, opioids, benzodiazepines, amphetamines, metamphetamines, MDMA or THC)
- •Positive urine pregnancy test or breastfeeding
- •Exposure to medication (including St. John's Wort) known to interfere with CYP3A4 metabolism within 14 days prior to dosing
- •Unable or unwilling to refrain from smoking, heavy physical exercise or the use of alcohol, xanthine, or grapefruit juice 24 hours prior to dosing until discharge.
- •Blood loss or donation outside the limits of the Dutch blood bank (Sanquin)
- •Participation in a clinical study within the past three months, or participation within four or more clinical studies in the past twelve months
研究者
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