Comparison of multiple doses of intramuscular versus intranasal naloxone for reversal of opioid toxicity

eiden University Medical Center0 个研究点目标入组 22 人开始时间: 2023年9月6日最近更新: 2023年9月18日

适应症

试验速览

暂无简介。

•Healthy volunteers + chronic opioid users:
•1. Aged 18-65 years with body mass index 19 - 40 kg/m²
•Additionally, for chronic opioid users:
•2. Opioid users: use opioids at daily doses = 60 mg oral morphine equivalents. No upper limit is set as would like to study as large as possible range of opioid use. It is our experience that the majority of patients use 60 - 600 mg oral morphine equivalents.
•3. 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.

•Healthy volunteers + chronic opioid users:
•1. A medical history of medical or psychiatric disease (incl. drug or alcohol addiction);
•2. Pregnancy or lactation;
•3. A positive drug urine dipstick on the screening or study days.
•4. History or presence of allergic response to study medication;
•Additionally, for chronic opioid users:
•5. 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;
•6. Any active medical condition, organ disease or concurrent medication or treatment that may either compromise subject safety or interfere with study endpoints;
•7. Currently receiving medication-assisted treatment for the treatment of opioid-use disorder;
•8. History or presence of allergic response to study medication;
•9. Treatment with mixed agonists-antagonists (such as buprenorphine) or use of benzodiazepines.

发起方

eiden University Medical Center