Influence of *9-tetrahydrocannabinol (THC) on oxycodone induced ventilatory depression in healthy volunteers

Influence of *9-tetrahydrocannabinol (THC) on oxycodone induced ventilatory depression in healthy volunteers - COXY study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON52028

Enrollment

Registered

2021-03-31

Start date

2021-11-25

Completion date

Unknown

Last updated

2024-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

opiaat bijwerkingen respiratory depression

Interventions

inhalation Bedrocan (with THC) and intake oxycodone or placebo On fixed timepoints: - respiratory measurements by giving CO2 - experimental pain test - questionnaires - blood sampling

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Healthy volunteers of either sex with earlier experience with cannabis (>2 lifetime exposures and

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 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

Secondary

Measure	Time frame
Secondary objective: To measure the effect of inhaled THC (100 mg Bedrocan) without and with concomitant intake of 20 mg oxycodone immediate release (IR) on - occurrence of apneic events; - occurrence of desaturation events; - baseline ventilation; - psychomimetic side effects as measured by Bowdle and Bond & Lader questionnaires; - cognition (p-deletion test) - pain pressure threshold - plasma concentrations of THC and oxycodone; - blood pressure and heart rate.	—

Measure

Time frame

Secondary objective: To measure the effect of inhaled THC (100 mg Bedrocan) without and with concomitant intake of 20 mg oxycodone immediate release (IR) on - occurrence of apneic events; - occurrence of desaturation events; - baseline ventilation; - psychomimetic side effects as measured by Bowdle and Bond & Lader questionnaires; - cognition (p-deletion test) - pain pressure threshold - plasma concentrations of THC and oxycodone; - blood pressure and heart rate.

—

Primary

Measure	Time frame
Primary objective: To measure the effect of inhaled THC (100 mg Bedrocan) on ventilation at isohypercapnia (end-tidal PCO2 = 55 mmHg) without and with concomitant intake of 20 mg oxycodone immediate release (IR) tablet in healthy volunteers 90 min after oxycodone intake.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)