Influence of Oxycodone on Individuals Taking an SSRI

• Status: Not yet recruiting
• Trial end date: 2025-04-15
• Target enrollment: 0
• Participant gender: All

Summary

This study will determine whether selective serotonin reuptake inhibitors (SSRI) exacerbate opioid induced respiratory depression in patients initiating treatment for underlying conditions such as depression or an anxiety disorder. Next to paroxetine which has been evaluated in a previous study in healthy volunteers sertraline, citalopram and escitalopram will be evaluated with regards to its influence on opioid induced respiratory depression.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Leiden University Medical Center
• Treatments: Oxycodone

Criteria

Inclusion Criteria:

• Signed the informed consent form (ICF) and able to comply with the study requirements and restrictions listed therein;

• Male and female subjects, age 18 to 75 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 agree to use a medically acceptable means of contraception from screening through at least 1 month after the last dose of study drug;

• Body Mass Index (BMI) 18 to 35 kg/m2, inclusive;

• Stable as defined by the Investigator, based on a medical evaluation that includes the subject's medical and surgical history, physical examination, vital signs;

• Using sertraline (minimal dose 50 mg), paroxetine minimal dose 20 mg), citalopram (minimal dose 20 mg) or escitalopram (minimal dose 10 mg).

Exclusion Criteria:

• 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;

• 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;

• 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]);

• Significant traumatic injury, major surgery, or open biopsy within the prior 4 weeks of informed consent;

• History of substance use disorder;

• 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;

• 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 subjects affiliated with, or a family member of, site staff directly involved in the study.

• Current use of any opioid.

• Opioid use less than 4 weeks prior to dosing with oxycodone in the current study.