Depression MedDRA version: 20.0 Level: PT Classification code 10038678 Term: Respiratory depression System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.0 Level: PT Classification code 10012378 Term: Depression System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Trade Name: Oxynorm
Product Name: Oxycodone
Product Code: RVG110728
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Sponsors
Leiden University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 75 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 35 kg/m2, inclusive; 5. Stable as defined by the Investigator, based on a medical evaluation that includes the subject’s medical and surgical history, physical examination, vital signs; 6. Using sertraline, paroxetine, citalopram or escitalopram. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: 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 caffeine, or nicotine; 2. Any 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, >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); 4. Currently receiving medication-assisted treatment for the treatment of opioid-use disorder; 5. Require on-going prescription or over-the-counter 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]); 6. Significant traumatic injury, major surgery, or open biopsy within the prior 4 weeks of informed consent; 7. History of substance use disorder; 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; 10. History or presence of allergic response to study medication; 11. 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; 12. Site staff or subjects affiliated with, or a family member of, site staff directly involved in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the effect of low-dose oxycodone versus placebo in individuals that either use a selective serotonin reuptake inhibitor (SSRI) such as sertraline, paroxetine, citalopram or escitalopram on ventilation at an extrapolated end-tidal carbon dioxide concentration of 55 mmHg.;Secondary Objective: To determine the effect of low-dose oxycodone versus placebo in individuals that use and SSRI on pupil diameter. ;Primary end point(s): The primary endpoint is ventilation measured at an extrapolated end-tidal PCO2 of 55 mmHg (VE55) at t = 4 h. ;Timepoint(s) of evaluation of this end point: Day 4-10 of start of treatment and days 25-45 of treatment. (1 session at each time frame) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): pupil diameter;Timepoint(s) of evaluation of this end point: Day 4-10 of start of treatment and days 25-45 of treatment. (1 session at each time frame) | — |
Countries
Netherlands
Contacts
Public ContactAlbert Dahan
Leiden University Medical Center
Outcome results
None listed