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6月2日最近更新: 2024年7月22日

适应症

试验速览

暂无简介。

•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.

•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.

发起方

eiden University Medical Center