Influence of oxycodone on individuals taking an SSRI

Recruiting

• Conditions: depression; Respiratory depression; 10027946

• Registration Number: NL-OMON51651
• Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 55

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.

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.
13.Current opioid use
14. Opioid use less than 4 weeks before dosing

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To determine the effect of low-dose (10 mg) oxycodone versus placebo in<br /><br>individuals that either use paroxetine, citalopram or escitalopram on<br /><br>ventilation at an extrapolated end-tidal carbon dioxide concentration of 55<br /><br>mmHg at 1 week (4-10 days) of SSRI treatment. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To determine the effect of low dose (10 mg) oxycodone versus placebo in<br /><br>individuals that either use paroxetine, citalopram or escitalopram on<br /><br>ventilation at an extrapolated end-tidal carbon dioxide concentration of 55<br /><br>mmHg following at 1 month (25-45 days) following initiation of SSRI treatment.<br /><br><br /><br>To determine the effect of low-dose oxycodone versus placebo in individuals<br /><br>that use and SSRI on pupil diameter. </p><br>