Status:
UNKNOWN
Influence of Δ9-tetrahydrocannabinol (THC) on Oxycodone Induced Ventilatory Depression in Healthy Volunteers
Lead Sponsor:
Leiden University Medical Center
Conditions:
Respiratory Depression
Cannabis Use
Eligibility:
All Genders
18-45 years
Phase:
PHASE4
Brief Summary
Rationale: Opioid misuse and abuse are common problems in the Western world. The rate of unintentional drug overdose is rapidly increasing, not only in the Unites States but also in the Netherlands. ...
Detailed Description
General study design The design of the study is randomized, placebo-controlled crossover. Each subject will be studied twice, on one occasion he or she will receive THC and a placebo opioid capsule, a...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 9 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05235503
Start Date
December 9 2021
End Date
June 1 2023
Last Update
February 11 2022
Active Locations (1)
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1
Leiden University Medical Center
Leiden, South Holland, Netherlands, 2333 ZA