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…
ID
Source
Brief title
Condition
- Mood disorders and disturbances NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To determine the effect of low-dose (10 mg) oxycodone versus placebo in
individuals that either use paroxetine, citalopram or escitalopram on
ventilation at an extrapolated end-tidal carbon dioxide concentration of 55
mmHg at 1 week (4-10 days) of SSRI treatment.
Secondary outcome
To determine the effect of low dose (10 mg) oxycodone versus placebo in
individuals that either use paroxetine, citalopram or escitalopram on
ventilation at an extrapolated end-tidal carbon dioxide concentration of 55
mmHg following at 1 month (25-45 days) following initiation of SSRI treatment.
To determine the effect of low-dose oxycodone versus placebo in individuals
that use and SSRI on pupil diameter.
Background summary
In a recent study, in collaboration with the US FDA, we observed that 1-5 days
paroxetine treatment in healthy volunteers enhanced oxycodone-induced
respiratory depression. It remains unknown whether this is true for patients
that use an antidepressant such as paroxetine.
Study 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.
Study design
This is a randomized double blind, placebo-controlled, crossover study.
Intervention
Subjects will receive an oral oxycodone 10 mg immediate release tablet or a
placebo tablet.
Respiration will be measured by rebreating from aballoon.
Study burden and risks
Apart from mild respiratory depression and pissbly nausea, we expete minimal
burden to the subjects.
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
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
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
EudraCT | EUCTR2022-001824-13-NL |
CCMO | NL81527.058.22 |