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

Completed

• Conditions: opiaat bijwerkingen; respiratory depression

• Registration Number: NL-OMON52028
• Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-06-29
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 32

Inclusion Criteria

Healthy volunteers of either sex with earlier experience with cannabis (>2
lifetime exposures and <2x/week in the last 12 months).
- aged 18-45 years,
- body mass index < 30 kg.m-2,
- able to understand the written informed consent form,
- able to communicate with the staff,
- able and willing to complete the study procedures,
- signed the informed consent form,
- deemed suitable by the investigators.

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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