Reversal of opioid-induced respiratory depression with opioid antagonists - a study in opioid naïve individuals and chronic opioid users under real-life conditions - ROAR

eiden University Medical Center0 sites24 target enrollmentOctober 21, 2021

Drugsfentanyl Sufenta Narcan

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: eiden University Medical Center
Enrollment: 24
Status: Active, not recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

October 21, 2021

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

eiden University Medical Center

Eligibility Criteria

Inclusion Criteria

•Healthy volunteers
•1\. Signed the informed consent form (ICF) and able to comply with the study requirements and restrictions listed therein;
•2\. Male and female subjects, age 18 to 45 years, inclusive;
•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;
•4\. Body Mass Index (BMI) 18 to 30 kg/m2, inclusive;
•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;
•6\. No history of substance use disorder;
•7\. No current use of any central nervous system (CNS) depressants prescribed or otherwise.
•Chronic opioid users
•1\. Signed the consent form and able to comply with the requirements and restrictions listed therein;

Exclusion Criteria

•Healthy volunteers
•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;
•2\. Any other active medical condition, organ disease or concurrent medication or treatment that may either compromise subject safety or interfere with study endpoints;
•3\. Consume, on average, \>20 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);
•4\. Previous treatment with any prescribed medications or over\-the\-counter (OTC) medications (including homeopathic preparations, vitamins, and minerals) within 14 days or 5 half\-lives (whichever is longer) prior to first study treatment administration;
•5\. Previous or current treatment with opioid agonist, partial agonist, or antagonist treatment within 30 days prior to the first study drug administration;
•6\. Require on\-going prescription or OTC medications that are clinically relevant CYP P450 3A4 or CYP P450 2C8 inducers or inhibitors (e.g., rifampicin, azole antifungals \[e.g., ketoconazole], macrolide antibiotics \[e.g., erythromycin]);
•7\. Significant traumatic injury, major surgery, or open biopsy within the prior 4 weeks of informed consent;
•8\. 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;
•9\. Measured systolic blood pressure greater than 160 or less than 95 mmHg or diastolic pressure greater than 95 mmHg at screening;