Clinical TrialHealthy VolunteersPsilocybinPlaceboNot yet recruiting

Psilocybin as a tool for enhancing cognitive flexibility

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.

Target Enrollment
60 participants
Study Type
interventional
Design
Randomized, double Blind
Registry
NTR / NL6007

Detailed Description

Randomised, double-blind, placebo-controlled parallel design in healthy volunteers (n=60) assessing a single oral dose of psilocybin (0.17 mg/kg) versus placebo on divergent thinking and goal-directed versus habitual behaviour with stress induction.

Outcomes include behavioural measures of divergent thinking and goal-directed behaviour, cortical–subcortical functional connectivity and neurotransmission (GABA and glutamate), subjective experience, pharmacokinetics and cortisol. Acute measurements up to 360 minutes post-dose and follow-up testing on day two (~150 minutes).

Study Protocol

Preparation

sessions

Dosing

1 sessions
360 min each

Integration

sessions

Study Arms & Interventions

Psilocybin

experimental

Single oral psilocybin dose

Interventions

  • Psilocybin0.17 mg/kg
    via Oral• single dose• 1 doses total

    Dose per bodyweight (0.17 mg/kg)

Placebo

inactive

Placebo comparator

Interventions

  • Placebo
    via Oral• single dose• 1 doses total

    Placebo capsule

Participants

Ages
18 – 40
Sexes
Male & Female

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

Study Details

  • Status
    Not yet recruiting
  • Type
    interventional
  • Design
    Randomizeddouble Blind
  • Target Enrollment60 participants
  • Timeline
    Start: 2017-05-01
    End: 2024-12-30
  • Compounds
    PsilocybinPlacebo
  • Topic
    Healthy Volunteers

Locations

Netherlands

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