NVT. De studiemedicatie wordt gegeven aan gezonde ouderen NVT
Conditions
Interventions
Volunteers will be randomized to receive 3 doses Namisol® (3 mg, 5 mg, 6,5 mg)
and placebo during 4 seperatie occasions (visit 1 to 4).
Sponsors
Universitair Medisch Centrum Sint Radboud
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Subject is a healthy old person as established by medical history, physical examination, electrocardiography, results of hematological and biochemical blood tests on screening. - Age 65 years or older - Body mass index (BMI) between 18.0 and 30 kg m-2 - Subject is able and willing to sign the Informed Consent Form prior to screening evaluations
Exclusion criteria
Exclusion criteria: - Regular cannabis user defined as: smoking one or more joints per week - Documented history of sensitivity/idiosyncrasy to cannabis - Relevant history or presence of severe pulmonary disorders [e.g. COPD GOLD III or IV], serious cardiovascular disorders [e.g. myocardial infarction = 10); mania; psychosis; dementia], cognitive impairment [based on documented history or MMSE on screening = twice the upper limit of normal], diabetes mellitus, coagulation disorders - Inability to understand the nature and extent of the trial and the procedures required - Current alcohol abuse or use of more than 2 alcoholic consumptions daily - History of, or current drug abuse - Using drugs that are inhibitors of CYP2C9, CYP2C19 and CYP3A4 (see appendix 13.3) - Participation in a drug trial within 60 days prior to the first intervention day - Donation of blood within 60 days prior to the first intervention day - Known lactosis intolerance - Using more than six units of (methyl)xanthine products per day (e.g. coffee, tea, cola, chocolate) - Smoking more than ten cigarettes per day - High fall-risk (based on Body Sway Test)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Safety and tolerability profiles of three oral doses of Namisol® | — |
Secondary
| Measure | Time frame |
|---|---|
| 1- The relationship between VAS-feeling high and the plasma concentrations of THC and its active metabolites 11-OH-THC and THC-COOH in a healthy elderly population at three different doses Namisol® 2- The relationship between TAP- alertness and the plasma concentrations of THC and its active metabolites 11-OH-THC and THC-COOH in a healthy elderly population at three different doses Namisol® 3- The relationship between Body Sway and the plasma concentrations of THC and its active metabolites 11-OH-THC and THC-COOH in a healthy elderly population at three different doses Namisol® | — |
Countries
Netherlands
Outcome results
None listed