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ID
Source
Health condition
psilocybin, divergent thinking, neurotransmission
Sponsors and support
Intervention
Outcome measures
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.
Background summary
Posttraumatic stress disorder (PTSD) is an anxiety disorder in which an individual’s ability to function is impaired by emotional responses to memories of a traumatic event. It is typically a chronic illness associated with high rates of psychiatric and medical comorbidity, disability, suffering, drug abuse, and suicide. However despite the high incidence of PTSD, current therapies provide limited effectiveness, with many people being unresponsive to treatment. Suggestions for effective treatments for PTSD include a hypothetical drug that would be capable of enhancing divergent thinking, a cognitive process used to generate as many innovative ideas as possible. A recent study from our lab showed that psychedelics significantly increased divergent thinking after drug intake. Furthermore, imaging studies have shown that the classic psychedelic, psilocybin, promotes a de-synchronization in the default mode network that is suggested to result in cognitive flexibility and enhanced creative thinking. Taken together these studies suggest that psilocybin can enhance divergent thinking, which may provide therapeutic potential in facilitating goal directed over habitual behaviour. Principal demonstrations showing that psilocybin facilitates cognitive flexibility would be very relevant for future support of clinical applications of psilocybin assisted therapy in PTSD patients, and may provide therapeutic potential for patients whom current options are not effective.
Study objective
The study will assess drug-induced change in performance in divergent thinking and goal-directed behaviour when comparing psilocybin to placebo, before and after an induction of stress. Additional study parameters include frontal-subcortical connectivity alterations and neurotransmission of glutamate and GABA between treatment conditions, as well as subjective questionnaires, pharmacokinetics, and cortisol.
Study design
Measurements will take place up until 360 minutes after drug intake on testing day one. Testing day two includes up to 2.5 hours of follow up measurements.
Intervention
psilocybin (.17 mg/kg) bodyweight or placebo;
Maastricht acute stress test or placebo
Natasha Mason
Universiteit Maastricht
Faculteit der Psychologie en Neurowetenschappen
Capgroep Neuropsychologie & Psychofarmacologie
Maastricht 6200 MD
The Netherlands
natasha.mason@maastrichtuniversity.nl
Natasha Mason
Universiteit Maastricht
Faculteit der Psychologie en Neurowetenschappen
Capgroep Neuropsychologie & Psychofarmacologie
Maastricht 6200 MD
The Netherlands
natasha.mason@maastrichtuniversity.nl
Inclusion criteria
• Previous experience with a psychedelic drug, but not within the past 6 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
• 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
Recruitment
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL6007 |
| NTR-old | NTR6505 |
| Other | METC : 173006 |