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Psilocybin as a tool for enhancing cognitive flexibility”


- candidate number26949
- NTR NumberNTR6505
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR22-mrt-2017
- Secondary IDs173006 METC
- Public TitlePsilocybin as a tool for enhancing cognitive flexibility”
- Scientific TitlePsilcobyin as a tool for enhaned divergent thinking and positive learning mechanisms
- ACRONYM
- hypothesisThe 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.
- Healt Condition(s) or Problem(s) studiedNeurotransmission, Cognition
- 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
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mei-2017
- planned closingdate1-mei-2020
- Target number of participants60
- Interventionspsilocybin (.17 mg/kg) bodyweight or placebo; Maastricht acute stress test or placebo
- Primary outcomeTo 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 outcomeTo 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.
- TimepointsMeasurements 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.
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES Natasha Mason
- CONTACT for SCIENTIFIC QUERIES Natasha Mason
- Sponsor/Initiator University Maastricht (UM)
- Funding
(Source(s) of Monetary or Material Support)
University Maastricht (UM)
- Publications
- Brief summaryPosttraumatic 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.
- Main changes (audit trail)
- RECORD22-mrt-2017 - 14-jul-2017


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