This interventional trial (n=60), conducted by the University Maastricht (UM), investigates the effects of psilocybin (12mg/70kg) on cognitive flexibility, specifically divergent thinking and goal-directed behaviour.
The study aims to assess drug-induced changes in performance by comparing psilocybin to a placebo, both before and after an induction of stress. Additional parameters include evaluating frontal-subcortical connectivity alterations, neurotransmission of glutamate and GABA, subjective experiences, pharmacokinetics, and cortisol levels. The study involves up to 360 minutes of measurements after drug intake on the first testing day and up to 2.5 hours of follow-up measurements on the second testing day.
The primary sponsor is the University of Maastricht. The study, pending recruitment completion, started on May 1, 2017, with an anticipated enrolment of 60 participants.
Trial Details
Primary outcome: to use psilocybin as a research tool in order to enhance divergent thinking, and facilitate relative goal-directed versus habitual behaviour during and after drug intoxication, and to assess whether psilocybin will deter a stress induced shift from goal directed to habitual behaviour. Secondary outcome: to assess cortical-subcortical functional connectivity alterations, as well as the relationship between metabolic activity and behavioural outcomes. Furthermore, subjective experience and drug concentration levels will be assessed in relation to the aforementioned variables.NCT Number
Sponsors & Collaborators
Maastricht UniversityMaastricht University is host to the psychopharmacology department (Psychopharmacology in Maastricht) where various researchers are investigating the effects of psychedelics.