healthy volunteers
Conditions
Interventions
Trade Name: oxycodone
Product Name: Oxycodone
Product Code: RVG110728
Pharmaceutical Form: Tablet
INN or Proposed INN: OXYCODONE
CAS Number: 76-42-6
Concentration unit: mg milligram(s)
Concentration t
Sponsors
Leiden University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - aged 18-45 years, - body mass index =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Presence or history of any medical or psychiatric disease (incl. a history of substance abuse, anxiety, or the presence of a painful syndrome such as fibromyalgia); - Use of any medication in the three months prior to the study (incl. paracetamol or other pain killers), except for oral contraceptives (females); - Use of more than 21 alcohol units per week; - Use of cannabis in the 4 weeks prior to the study; - A positive urinary drug test or a breath alcohol test at screening or on the morning of the experiment; - Pregnancy, lactating or a positive pregnancy test on the morning of the experiment; - Participation in another drug trial in the 60 days prior to dosing.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of the study is to quantify the interactive effect of ?9-tetrahydrocannabinol (THC) and oxycodone on ventilatory control. ;Secondary Objective: (1) Outcome of Bowdle and Bond & Lader questionnaires; (2) Level of sedation; (3) Hemodynamics; (4) Cognition (p-deletion test); (5) Pain Pressure Threshold; (6) slope of the hypercapnic ventilatory response; (7) plasma concentrations of THC, 11-OH-THC and oxycodone; a secondary analysis will be performed on the pharmacokinetic and pharmacodynamic data (PKPD modeling).;Primary end point(s): The effect of inhaled THC on ventilation at an end-tidal PCO2 = 55 mmHg without and with concomitant intake of 20 mg oxycodone immediate release (IR) tablet in healthy volunteers 120 min after oxycodone intake. ;Timepoint(s) of evaluation of this end point: 120 minutes after intake oxycodone or placebo | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): (1) Outcome of Bowdle and Bond & Lader questionnaires; (2) Level of sedation; (3) Hemodynamics; (4) Cognition (p-deletion test); (5) Pain Pressure Threshold; (6) slope of the hypercapnic ventilatory response; (7) plasma concentrations of THC, 11-OH-THC and oxycodone; a secondary analysis will be performed on the pharmacokinetic and pharmacodynamic data (PKPD modeling).;Timepoint(s) of evaluation of this end point: variable and across timepoints in trial | — |
Countries
Netherlands
Contacts
Public ContactMonique van Velzen
Leiden University Medical Center
Outcome results
None listed