Actively Recruiting
Reversal of Opioid-induced Respiratory Depression With Opioid Antagonists
Led by Leiden University Medical Center · Updated on 2025-01-31
24
Participants Needed
1
Research Sites
222 weeks
Total Duration
On this page
Sponsors
L
Leiden University Medical Center
Lead Sponsor
F
Food and Drug Administration (FDA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
n this pharmacokinetic/pharmacodynamic modelling study we will determine the ability of intranasal and intravenous naloxone and intravenous nalmefene to reverse opioid (fentanyl and sufentanil)- induced respiratory depression in healthy volunteers and chronic opioid users to develop dosing recommendations in case of opioid-induced respiratory depression from an opioid overdose in clinical practice and in the out-of-hospital overdose.
CONDITIONS
Official Title
Reversal of Opioid-induced Respiratory Depression With Opioid Antagonists
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent and able to follow study requirements
- Male or female aged 18 to 70 years
- Women of childbearing potential must have a negative pregnancy test and agree to use contraception during and for one month after the study (healthy volunteers) or three months after the study (chronic opioid users)
- Body Mass Index between 18 and 30 kg/m2 for healthy volunteers, 18 and 32 kg/m2 for chronic opioid users
- Healthy volunteers must be healthy based on medical evaluation and lab tests
- No history of substance use disorder for healthy volunteers
- Chronic opioid users must be stable opioid-tolerant patients taking at least 60 mg oral morphine equivalents daily
- Chronic opioid users must be stable based on medical evaluation including ECG and blood tests
You will not qualify if you...
- Diagnosis of substance use disorder (any substance) for healthy volunteers or moderate/severe substance use disorder for chronic opioid users (except opioids, caffeine, nicotine)
- Active medical conditions or treatments that risk safety or affect study results
- High alcohol consumption exceeding 27 units/week for men or 20 units/week for women (healthy volunteers) or 27 units/week for men or 20 units/week for women (chronic opioid users)
- Recent opioid agonist, partial agonist, or antagonist treatment within 30 days before study drug (healthy volunteers)
- Recent major surgery, traumatic injury, or open biopsy within 4 weeks before consent
- Recent suicidal ideation (within 30 days) or suicide attempt (within 6 months)
- Abnormal blood pressure at screening (systolic >160 or <95 mmHg, diastolic >95 mmHg)
- History of allergic reaction to fentanyl, sufentanil, naloxone, or study medications
- Allergic reactions that interfere with study participation
- Participation in other investigational drug studies within 3 months or more than 4 studies in the past year
- Site staff or family involved in the study
- For chronic opioid users: anemia or recent blood/plasma donation within 3 months
- For chronic opioid users: low kidney function (estimated glomerular filtration rate <60 mL/min)
- For chronic opioid users: positive tests for HIV, acute hepatitis B or C (asymptomatic hepatitis B or C allowed)
- Elevated liver enzymes (AST or ALT >3 times upper limit) for chronic opioid users
- Currently receiving medication-assisted treatment for opioid-use disorder (chronic opioid users)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Leiden University Medical Center
Leiden, South Holland, Netherlands, 2333 ZA
Actively Recruiting
Research Team
R
Rutger van der Schrier, MD
CONTACT
A
Albert Dahan, MD PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
4
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