EUCTR2021-000083-29-NLActive, not recruitingPhase 1
Influence of ?9-tetrahydrocannabinol (THC) on oxycodone induced ventilatory depression in healthy volunteers
eiden University Medical Center0 sites20 target enrollmentStarted: March 31, 2021Last updated:
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 20
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •- 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.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
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.
Investigators
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