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Reversal of opioid-induced respiratory depression with opioid antagonists - a pharmacokinetic pharmacodynamic modeling study in opioid naïve individuals and chronic opioid users under real-life conditions
EU CTIS ID: 2024-518041-16-00
What this study is testing
To describe the pharmacokinetics and pharmacodynamics of intravenous fentanyl and sufentanil on ventilation and the ability of intranasal and intravenous naloxone and intravenous nalmefene in its ability to reverse respiratory depression (important model parameters include C50, a measure of potency and t½ke0).
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Healthy 1. Signed the informed consent form (ICF) and able to comply with the study requirements and restrictions listed therein
- Chronic opioid users 4. BMI 18 to 32 kg/m2, inclusive;
- Chronic opioid users 5. Opioid tolerant patients administered prescription opioids at daily doses ≥ 60 mg oral morphine equivalents;
- Chronic opioid users 6. 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;
- Chronic opioid users 7. positive opioid urine drug screening;
- Chronic opioid users 8. positive naloxone challenge.
You likely can't join if
- Healthy 1. Currently meet the criteria for diagnosis of substance use disorder according to the Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria on any substance
- Healthy 10. Treatment with another investigational drug within 3 months prior to dosing or having participated in more than 4 investigational drug studies within 1 year prior to screening
- Healthy 11. Site staff or subjects affiliated with, or a family member of, site staff directly involved in the study;
- Chronic opioid users 1. 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 2. 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 3. Consume, on average, >27 units/week of alcohol in men and >20 units/week of alcohol in women (1 unit = 1 glass (250 mL) beer, 125 mL glass of wine or 25 mL of 40% spirit);
See the full eligibility criteria
Who can join
- Healthy 1. Signed the informed consent form (ICF) and able to comply with the study requirements and restrictions listed therein
- Chronic opioid users 4. BMI 18 to 32 kg/m2, inclusive;
- Chronic opioid users 5. Opioid tolerant patients administered prescription opioids at daily doses ≥ 60 mg oral morphine equivalents;
- Chronic opioid users 6. 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;
- Chronic opioid users 7. positive opioid urine drug screening;
- Chronic opioid users 8. positive naloxone challenge.
- Healthy 2. Male and female subjects, age 18 to 70 years, inclusive
- Healthy 3. Women of childbearing potential (defined as all women who are not surgically sterile or postmenopausal for at least 1 year prior to informed consent) must have a negative serum pregnancy test prior to enrolment and must agree to use a medically acceptable means of contraception from screening through at least 1 month after the last dose of study drug
- Healthy 4. Body Mass Index (BMI) 18 to 30 kg/m2, inclusive;
- Healthy 5. Healthy as defined by the Investigator, based on a medical evaluation that includes the subject’s medical and surgical history, physical examination, vital signs, lab chemistry: estimated glomerular filtration rate >60 mL/min as estimated by the CKD-EPI equation, and AST or ALT levels < 3.0 times the upper limit of normal at screening, and negative serology tests for HIV, acute hepatitis B, or acute hepatitis C;
- Healthy 6. No history of substance use disorder
- Chronic opioid users 1. Signed the consent form and able to comply with the requirements and restrictions listed therein;
- Chronic opioid users 2. Males or females age 18 to 70 years, inclusive
- Chronic opioid users 3. Women of childbearing potential (defined as all women who are not surgically sterile or postmenopausal for at least 1 year prior to informed consent) must have a negative serum pregnancy test prior to enrolment and must agree to use a medically acceptable means of contraception from screening through at least 3 months after the last dose of study drug.
What rules you out
- Healthy 1. Currently meet the criteria for diagnosis of substance use disorder according to the Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria on any substance
- Healthy 10. Treatment with another investigational drug within 3 months prior to dosing or having participated in more than 4 investigational drug studies within 1 year prior to screening
- Healthy 11. Site staff or subjects affiliated with, or a family member of, site staff directly involved in the study;
- Chronic opioid users 1. 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 2. 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 3. Consume, on average, >27 units/week of alcohol in men and >20 units/week of alcohol in women (1 unit = 1 glass (250 mL) beer, 125 mL glass of wine or 25 mL of 40% spirit);
- Chronic opioid users 4. Currently receiving medication-assisted treatment for the treatment of opioid-use disorder
- Chronic opioid users 5. Significant traumatic injury, major surgery, or open biopsy within the prior 4 weeks of informed consent;
- Chronic opioid users 6. History of suicidal ideation within 30 days prior to informed consent or history of a suicide attempt in the 6 months prior to informed consent;
- Chronic opioid users 7. Measured systolic blood pressure greater than 160 or less than 95 mmHg or diastolic pressure greater than 95 mmHg at screening;
- Chronic opioid users 8. History or presence of allergic response to fentanyl, sufentanil, nalmefene or naloxone
- Healthy 2. Any other active medical condition, organ disease or concurrent medication or treatment that may either compromise subject safety or interfere with study endpoints;
- Chronic opioid users 9. Opioid tolerant patients who have demonstrated allergic reactions (e.g., food, drug, atopic reactions or asthmatic episodes) which, in the opinion of the Investigator and sponsor, interfere with their ability to participate in the trial.
- Chronic opioid users 10. Estimated glomerular filtration rate <60 mL/min as estimated by the CKD-EPI equation;
- Chronic opioid users 11. Anemia at screening or donation of > 250 mL of blood or plasma within the last 3 months;
- Chronic opioid users 12. Positive serology tests for HIV, acute hepatitis B, or acute hepatitis C (OT patients with asymptomatic hepatitis B or C infection may be enrolled);
- Chronic opioid users 13. AST or ALT levels >3.0 times the upper limit of normal at screening;
- Chronic opioid users 14. Treatment with another investigational drug within 3 months prior to dosing or having participated in more than 4 investigational drug studies within 1 year prior to screening
- Chronic opioid users 15. Site staff or subjects affiliated with, or a family member of, site staff directly involved in the study
- Healthy 3. Consume, on average, >27 units/week of alcohol in men and >13 units/week of alcohol in women (1 unit = 1 glass (250 mL) beer, 125 mL glass of wine or 25 mL of 40% spirit);
- Healthy 4. Previous or current treatment with opioid agonist, partial agonist, or antagonist treatment within 30 days prior to the first study drug administration
- Healthy 5. Significant traumatic injury, major surgery, or open biopsy within the prior 4 weeks of informed consent
- Healthy 6. History of suicidal ideation within 30 days prior to informed consent or history of a suicide attempt in the 6 months prior to informed consent
- Healthy 7. Measured systolic blood pressure greater than 160 or less than 95 mmHg or diastolic pressure greater than 95 mmHg at screening
- Healthy 8. History or presence of allergic response to fentanyl, sufentanil or naloxone or nalmefene
- Healthy 9. Subjects who have demonstrated allergic reactions (e.g., food, drug, atopic reactions or asthmatic episodes) which, in the opinion of the Investigator and sponsor, interfere with their ability to participate in the trial
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.