no health condition is being address in the research, and healthy volunteers who have previous experience with psychedelics will be recruited n.a.
Conditions
Interventions
Administration of treatments (see objective of the study and study design), the
Maastricht Acute Stress Test, and collection of blood samples each test day to
determine treatment concentrations,cort
creativity
goal-directed
Psilocybin
Sponsors
Universiteit Maastricht
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: * Previous experience with a psychedelic drug, but not within the past 3 months. * Age between 18 and 40 years * Free from psychotropic medication * Good physical health as determined by medical examination and laboratory analysis * Absence of any major medical, endocrine and neurological condition * Normal weight, body mass index (weight/height2) between 18 and 28 kg/m2 * Proficient knowledge of the English language, defined as having at least 5 years of English language education (in high school or other education) * Written Informed Consent
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: * History of drug addiction (determined by the medical questionnaire, drug questionnaire and medical examination) * Previous experience of serious side effects to psychedelic drugs (anxiety or panic attacks) * Pregnancy or lactation * Hypertension (diastolic> 90; systolic> 140) * Current or history of psychiatric disorder (determined by the medical questionnaire and medical examination) * Liver dysfunction * History of cardiac dysfunctions (arrhythmia, ischemic heart disease,*) * For women: no use of a reliable contraceptive
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Divergent thinking will be measured using the picture concept test and the alternate uses test Outcome measures of these tests include fluency, originality, quantity, quality, and flexibility of answers. Behavior switching will be measured via the three-stage instrumental learning task. Outcome measures of this test include accuracy and reaction time. | — |
Secondary
| Measure | Time frame |
|---|---|
| Underlying receptor mechanisms will be assessed via ketanserin. Functional connectivity will be measures via functional magnetic resonance imaging. Neurotransmission and metabolic activity will be measured via proton magnetic resonance imaging. Drug kinetics will be assessed via blood samples. Subjective experience will be assessed via questionnaires (Visual analogue scale, five-dimensional altered states of consciousness, profile of mood states, ego-dissolution inventory, and the persisting effects questionnaire). Neuroendocrine stress markers will be assessed via cortisol concentrations in saliva. Additionally, cognitive and affective empathy will be assessed using the multifacted empathy test. | — |
Countries
The Netherlands
Outcome results
None listed