Clinical TrialHealthy VolunteersPsilocybinMDMAPlaceboCompleted

Does Serotonin System Stimulation Increase Pro-social Behavior? – A Comparative Pharmacological Neuroscientific Study in Healthy Humans

This Phase I intervention trial (n=120) investigates whether stimulating the serotonin system influences pro-social behaviour compared to stimulating the dopamine system in healthy individuals; single-dose psilocybin (15 mg), MDMA (100 mg) or methylphenidate (60 mg) in a double-blind randomized parallel design.

Target Enrollment
120 participants
Study Type
Phase I interventional
Design
Randomized, double Blind

Detailed Description

Randomized, double-blind, single-center, parallel-group Phase I study in healthy volunteers comparing single doses of psilocybin (15 mg), MDMA (100 mg) and methylphenidate (60 mg) to investigate pro-social cognition.

Objective, ecologically valid measures of pro-social behaviour will be assessed acutely and at four weeks to determine lasting and pharmacology-specific effects; safety and tolerability monitored by standard clinical and laboratory measures.

Study Protocol

Preparation

sessions

Dosing

1 sessions

Integration

sessions

Study Arms & Interventions

Psilocybin

active comparator

Single oral dose psilocybin (capsule), 40 participants.

Interventions

  • Psilocybin15 mg
    via Oral• single dose• 1 doses total

    Oral capsule

MDMA

active comparator

Single oral dose MDMA (capsule), 40 participants.

Interventions

  • MDMA100 mg
    via Oral• single dose• 1 doses total

    Oral capsule

Methylphenidate

active comparator

Single oral dose methylphenidate, 40 participants.

Interventions

  • Placebo60 mg
    via Oral• single dose• 1 doses total

    Methylphenidate 60 mg (encoded as non-psychedelic comparator)

Participants

Ages
18 – 40
Sexes
Male & Female

Inclusion Criteria

  • Healthy male or female aged 18-40
  • Willing and capable to give informed consent (signed ICF)
  • Willing to refrain from alcohol the day before testing, from alcohol and caffeinated drinks on testing days, and from psychoactive substances two weeks before the first visit and for study duration
  • Willing to abstain from drugs that may interfere with study medications (sleeping aids, cough meds, beta-blockers, etc.)
  • Able and willing to comply with study requirements
  • Good physical health with no unstable medical conditions per history, exam, labs, ECG, urine analysis/toxicology
  • Women of childbearing potential must use effective contraception for the entire study; pregnant or breastfeeding women excluded
  • Willing not to drive or operate machines for 48h following administration
  • Have a friend/family member to pick them up after dosing

Exclusion Criteria

  • Poor knowledge of German
  • Previous significant adverse response to a hallucinogenic drug (incl. psilocybin), MDMA, or methylphenidate
  • Allergy or hypersensitivity to MDMA, psilocybin, or methylphenidate
  • Lifetime use of hallucinogens, MDMA, or methylphenidate on >10 occasions
  • Personal or family history of major psychiatric disease (e.g., schizophrenia, schizoaffective disorder, psychosis, major depression, bipolar disorder, substance addiction/abuse other than caffeine and nicotine) in 1st or 2nd degree relatives
  • History of suicidal behavior
  • Inability to follow study procedures (language problems, cognitive impairment, etc.)
  • ADHD
  • Any current major medical condition or unstable illness per history or labs
  • Uncorrected thyroid disease
  • Uncorrected hypo- or hypertension
  • Epilepsy
  • Abnormal ECG
  • BMI <17 or >35
  • Personal history of head trauma, brain/cardiac surgery, fainting, or ECT
  • Personal or family history of seizure disorder and strokes (1st and 2nd degree relatives)
  • Participation in another drug trial within 30 days
  • Current psychopharmacological treatment or medications affecting brain function
  • Use of contraindicated medications (MAOIs, antidepressants, sedatives, etc.)
  • Women who are pregnant, breastfeeding, or intend to become pregnant during the study

Study Details

  • Status
    Completed
  • Phase
    Phase I
  • Type
    interventional
  • Design
    Randomizeddouble Blind
  • Target Enrollment120 participants
  • Timeline
    Start: 2023-10-24
    End: 2025-06-30
  • Compounds
    PsilocybinMDMAPlacebo
  • Topic
    Healthy Volunteers

Locations

Psychiatrische Universitätsklinik Zürich — Zurich, Canton of Zurich, Switzerland

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