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New treatment option for Opioid Induced Respiratory Depression
Official title Reversal of Opioid-induced Respiratory Depression With Opioid Antagonists
ClinicalTrials.gov ID: NCT05338632
What this study is testing
What is Narcan 40 MG/ML Nasal Spray?
Narcan 40 MG/ML Nasal Spray is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for opioid induced respiratory depression.
Also referred to as Intranasal naloxone.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70. Healthy volunteers may be eligible.
You may be able to join if
- Healthy volunteers
- Signed the informed consent form (ICF) and able to comply with the study requirements and restrictions listed therein;
- Male and female people, age 18 to 70 years, inclusive;
- Women of childbearing potential (defined as all women who are not surgically sterile or postmenopausal for at least 1 year prior to informed consent)...
- Body Mass Index (BMI) 18 to 30 kg/m2, inclusive;
You likely can't join if
- Healthy volunteers
- Currently meet the criteria for diagnosis of substance use disorder according to the Diagnostic and Statistical Manual of Mental Disorders (DSM)-5...
- Any other active medical condition, organ disease or concurrent medication or treatment that may either compromise subject safety or interfere with...
- Consume, on average, \>27 20 units/week of alcohol in men and \> 20 13 units/week of alcohol in women (1 unit = 1 glass (250 mL) beer, 125 mL glass...
- Previous or current treatment with opioid agonist, partial agonist, or antagonist treatment within 30 days prior to the first study drug...
- Significant traumatic injury, major surgery, or open biopsy within the prior 4 weeks of informed consent;
See the full eligibility criteria
Who can join
- Healthy volunteers
- Signed the informed consent form (ICF) and able to comply with the study requirements and restrictions listed therein;
- Male and female people, age 18 to 70 years, inclusive;
- 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...
- Body Mass Index (BMI) 18 to 30 kg/m2, inclusive;
- 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...
- No history of substance use disorder; Chronic opioid users
- Signed the consent form and able to comply with the requirements and restrictions listed therein;
- Males or females age 18 to 70 years, inclusive;
- 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...
- BMI 18 to 32 kg/m2, inclusive;
- Opioid tolerant patients administered prescription opioids at daily doses ≥ 60 mg oral morphine equivalents (See Table 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;
What rules you out
- Healthy volunteers
- 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;
- Any other active medical condition, organ disease or concurrent medication or treatment that may either compromise subject safety or interfere with study endpoints;
- Consume, on average, \>27 20 units/week of alcohol in men and \> 20 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);
- Previous or current treatment with opioid agonist, partial agonist, or antagonist treatment within 30 days prior to the first study drug administration;
- Significant traumatic injury, major surgery, or open biopsy within the prior 4 weeks of informed consent;
- 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;
- Measured systolic blood pressure greater than 160 or less than 95 mmHg or diastolic pressure greater than 95 mmHg at screening;
- History or presence of allergic response to fentanyl, sufentanil or naloxone;
- people 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;
- 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;
- Site staff or people affiliated with, or a family member of, site staff directly involved in the study; 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;
- Any active medical condition, organ disease or concurrent medication or treatment that may either compromise subject safety or interfere with study endpoints;
- 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);
- Currently receiving medication-assisted treatment for the treatment of opioid-use disorder;
- Significant traumatic injury, major surgery, or open biopsy within the prior 4 weeks of informed consent;
- 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;
- Measured systolic blood pressure greater than 160 or less than 95 mmHg or diastolic pressure greater than 95 mmHg at screening;
- History or presence of allergic response to study medication;
- 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...
- Estimated glomerular filtration rate \<60 mL/min as estimated by the CKD-EPI equation;
- Anemia at screening or donation of \> 250 mL of blood or plasma within the last 3 months;
- Positive serology tests for HIV, acute hepatitis B, or acute hepatitis C (OT patients with asymptomatic hepatitis B or C infection may be enrolled);
- AST or ALT levels \>3.0 times the upper limit of normal at screening;
- 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;
- Site staff or people affiliated with, or a family member of, site staff directly involved in the study.
The study team makes the final eligibility decision.
Where it's taking place
- Leiden, South Holland, Netherlands
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 years to 70 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Leiden, South Holland, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.