2023-505338-93-00已完成2 期
Comparison of multiple doses of intramuscular versus intranasal naloxone for reversal of opioid toxicity
Leiden University Medical Center1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2023年8月14日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- • Number of naloxone administrations
研究概览
简要总结
The number IM and IN administrations needed to restore ventilation to baseline levels in healthy volunteers
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Aged 18-65 years with body mass index 19-40 kg/m2
- •Opioid users: use opioids at daily doses ≥ 60 mg oral morphine equivalents. . No upper limit is set as would like to study an as large as possible range of opioid use. It is our experience that the majority of patients uses 60-600 mg oral morphine equivalents.
- •Opioid users: • Stable as defined by the Investigator, based on a medical evaluation that includes the subject’s medical and surgical history, physical examination, vital signs, 12-lead ECG, hematology, and blood chemistry.
排除标准
- •A medical history of medical or psychiatric disease (incl. drug or alcohol addiction);
- •Pregnancy or lactation
- •A positive drug urine dipstick on the screening or study days
- •History or presence of allergic response to study medication
- •for chronic opioid users: • Currently meet the criteria for diagnosis of moderate or severe substance use disorder according to the DSM-5 criteria on any substances other than opioids, caffeine, or nicotine;
- •Chronic opioid users: Any active medical condition, organ disease or concurrent medication or treatment that may either compromise subject safety or interfere with study endpoints;
- •Chronic opioid users: Currently receiving medication-assisted treatment for the treatment of opioid-use disorder;
- •Treatment with mixed agonists-antagonists (such as buprenorphine) or use of benzodiazepines.
结局指标
主要结局
• Number of naloxone administrations
• Number of naloxone administrations
次要结局
- • Number of naloxone administrations
- • Timing of minute ventilation, end-tidal PCO2 and plasma concentrations of naloxone
- • Plasma concentrations of naloxone and fentanyl
- • Pupil diameter and muscle tone
研究者
Albert Dahan, MD PhD
Scientific
Leiden University Medical Center
研究点 (1)
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