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

Phase 1

Recruiting

• Conditions: Healthy volunteers; Therapeutic area: Phenomena and Processes [G] - Physiological processes [G07]; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: CTIS2023-505338-93-00
• Lead Sponsor: eiden University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-02
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The number IM and IN administrations needed to restore ventilation to baseline levels in healthy volunteers;Secondary Objective: The number IM and IN administrations needed to restore ventilation to baseline levels in chronic opioid users, Naloxone-induced changes in minute ventilation, end-tidal PCO2 and plasma concentrations of naloxone upon naloxone (either IM or IN) administration as a function of time., Naloxone and fentanyl pharmacokinetics, Effect of fentanyl and naloxone on pupil diameter and muscle tone;Primary end point(s): •Number of naloxone administrations

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):•Number of naloxone administrations;Secondary end point(s):•Timing of minute ventilation, end-tidal PCO2 and plasma concentrations of naloxone;Secondary end point(s):•Plasma concentrations of naloxone and fentanyl;Secondary end point(s):•Pupil diameter and muscle tone