Comparing the effects of giving various doses of medication through injection into the muscle versus using a nasal spray. This is to see which method works better in reversing the harmful effects of taking too many opioid drugs.

Not Applicable

• Conditions: Healthy volunteers and chronic opioid users; Not Applicable

• Registration Number: ISRCTN21068708
• Lead Sponsor: eiden University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-09-06
• Last Update Posted: 18 September 2023
• Study Completion: 2024-09-01

Recruitment & Eligibility

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

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified