Psychosis Psychotic disorder
Conditions
Interventions
The drugs used in the study are olanzapine 10 mg orally, diphenhydramine 2x15
mg orally and/or THC intrapulmonary (2, 4, and 6 mg with intervals of 90
minutes) or placebo of any of these drugs.
Sponsors
Centre for Human Drug Research
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Male sex • Age between 18 and 45 (extremes included) • Body Mass Index (BMI) between 18 and 30 kg/m2 (extremes included) • Mild cannabis user for at least one year, defined as use of cannabis no more than once a week (as an average in the last year) • Ability to refrain from using cannabinoids (other than the THC used in the study) from at least two weeks prior to the first treatment period till the end of the follow-up periods • Willing to give written informed consent to participate in the study and to comply with the study procedures
Exclusion criteria
Exclusion criteria: • Clinically significant (history of) psychiatric illness (including substance abuse) • Clinically significant cardiac, pulmonary, gastrointestinal, hepatic, renal, haematological, endocrine or neurological disease as determined by medical history, physical examination, ECG or laboratory test results • Family history (first-degree relatives) of relevant psychiatric disorders and/or family history (second-degree relatives) of psychotic disorders • Participation in a clinical study within the past three months • Participation in four or more clinical studies in the past twelve months • Positive urine screen for recreational drugs, i.e. cocaine, opioids, benzodiazepines, amphetamines, metamphetamines, or MDMA. THC will be tested as well; since volunteers are cannabis users, subjects with a positive THC urine test will be tested again and have to be found THC-negative before the first study day. Subjects with a positive drug test on a study day, including THC, will be excluded • Exposure to any medication, including over-the-counter medication and herbal agents, 14 days prior to randomization (except paracetamol) • Exposure to prescription medication within 30 days prior to screening • Positive testing for Hepatitis B or C, or HIV-1 or HIV-2 • Smokes more than four cigarettes per day • Unable or unwilling to refrain from alcohol, starting 24 hours before each study day until the end of the study day • Unable or unwilling to refrain from smoking on study days • Unable or unwilling to refrain from xanthine (i.e. caffeine) intake on study days • Unable or unwilling to refrain from quinine (bitter drinks in general, i.e. tonic, grapefruit juice) from 14 days before dosing until discharge • Unable or unwilling to refrain from heavy physical exercise 24 hours before study days • Unable or unwilling to maintain a regular day/night rhythm during the study • Donation (or loss) of more blood, including this study, than allowed by the regulations of the Dutch blood bank (Sanquin) • Relevant (history of) drug allergy or hypersensitivity to drugs • Subject is the investigator or any sub-investigator, or a subordinate of the investigator or any sub-investigator
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| - other parameters for the functioning of the central nervous systems (see protocol chapter 7) | — |
Primary
| Measure | Time frame |
|---|---|
| - the PANSS (Positive and Negative Syndrome Scale - a widely used, clinical questionnaire based on a semi-structured interview) - Visual Analogue Scales (VAS - Bond & Lader, Bowdle - validated scales to objectify subjective parameters) | — |
Countries
Netherlands
Outcome results
None listed