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CompletedPhase 1

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

NCT06081179 · University of Zurich

Closed to entry
Status
Not accepting participants
Phase 1
Phase
122
Target enrolment
1
Study sites
Outside the US

What it is testing

Summary

The study looks into whether administering psychedelic substances that stimulate the serotonin system influences pro-social behavior when compared to administering substances that stimulate the dopamine system in healthy individuals.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Multifaceted Empathy Test

    Measured over t0 - 10 days (+/- 7 days) and t0 + 4 weeks (+/- 3 days); t0 being the day of substance administration

  • Moral Inference Task

    Measured over t0 - 10 days (+/- 7 days) and t0 + 4 weeks (+/- 3 days); t0 being the day of substance administration

  • Zurich Prosocial Game

    Measured over t0 - 10 days (+/- 7 days) and t0 + 4 weeks (+/- 3 days); t0 being the day of substance administration

  • Social Gaze Task

    Measured over t0 - 10 days (+/- 7 days) and t0 + 4 weeks (+/- 3 days); t0 being the day of substance administration

  • Moral Expansion Task

    Measured over t0 - 10 days (+/- 7 days) and t0 + 4 weeks (+/- 3 days); t0 being the day of substance administration

  • Social Network Questionnaire

    Measured over t0 - 10 days (+/- 7 days) and t0 + 4 weeks (+/- 3 days); t0 being the day of substance administration

  • Pro-social Voting Behavior

    Measured over t0 - 10 days (+/- 7 days) and t0 + 4 weeks (+/- 3 days); t0 being the day of substance administration

  • Oxford Utilitarianism Scale

    Measured over t0 - 10 days (+/- 7 days) and t0 + 4 weeks (+/- 3 days); t0 being the day of substance administration

  • Compassion Scale

    Measured over t0 - 10 days (+/- 7 days) and t0 + 4 weeks (+/- 3 days); t0 being the day of substance administration

  • Inclusion of others in the self

    Measured over t0 - 10 days (+/- 7 days), t0, and t0 + 4 weeks (+/- 3 days); t0 being the day of substance administration

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 40 Years
Ages
All
Sex
Accepted
Healthy volunteers
Inclusion Criteria: * Healthy male or female at the age of 18-40 * Willing and capable to give informed consent for study participation as documented by signature (Informed Consent Form) after the nature of the study has been thoroughly explained * Willing to refrain from drinking alcohol the day before testing session, from drinking alcohol and caffeinated drinks at the testing days and from consuming psychoactive substances two weeks before the first investigation visit and for the duration of the study * Willing to abstain from using drugs that may interfere with the effects of the study medications including sleeping aids, cough medications, beta-blocker or other substances with potentially relevant psychoactive and cardiovascular effects. * Able and willing to comply with all study requirements * Good physical health with no unstable medical conditions, as determined by medical history, physical examination, routine blood labs, electrocardiogram, urine analysis, and urine toxicology * Women of childbearing potential (as defined by: 'the age of carrying or giving birth to a child', normally between 14-45 years of age, not in menopause, last menstrual period (LMP) less than 12 months, no removal of ovaries or uterus, no ligature of Fallopian tubes') must be using an effective, established method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices. Note: female participants who are surgically sterilized/hysterectomized or post-menopausal for longer than 2 years are not considered as being of childbearing potential * Willing not to drive a traffic vehicle or to operate machines within 48h following substance administration * Have a family member or friend who can pick them up after the substance administration sessions (driving is forbidden at drug treatment days) Exclusion Criteria: * Poor knowledge of the German language * Previous significant adverse response to a hallucinogenic drug (incl. psilocybin), MDMA, or methylphenidate * Allergy or hypersensitivity to previous use of MDMA, psilocybin, or methylphenidate * Lifetime history of hallucinogen (incl. psilocybin), MDMA, or methylphenidate use on more than 10 occasions * Personal and family history of major psychiatric disease (e.g., schizophrenia, schizoaffective disorder, psychosis, major depression, bipolar disorder, psychotic disorder, substance addiction/abuse other than caffeine and nicotine) as defined in the DSM-V (1st and 2nd degree relatives) * History of suicidal behavior * Inability to follow the procedures of the study, e.g., due to language problems, psychological disorders, dementia, etc. of the participant * Attention-Deficit/Hyperactivity-Disorder (ADHD) * Any current major medical condition (e.g., neurologic, cardiovascular, metabolic, infectious disease) or any unstable illness as determined by medical history or laboratory tests * Uncorrected hypo-or hyperthyroidism * Uncorrected hypo-and hypertension * Epilepsy * Abnormal electrocardiogram * BMI \<17 or \>35 * Personal history of head trauma, brain/cardiac surgery, fainting, or electroconvulsive therapy * Personal and family history of seizure disorder and strokes (1st and 2nd degree relatives) * Participation in another study where pharmaceutical compounds are given within the 30 days preceding and during the present study * Current psychopharmacological treatment or medication that affects brain function * Use of medications that are contraindicated or otherwise interfere with the effects of the study medications (monoamine oxidase inhibitors, antidepressants, sedatives etc.) * Women who are pregnant or breast feeding, or have the intention to become pregnant during the study (for safety reasons, a urine pregnancy test will be done at the screening visit and before the substance administration) * Enrollment of the investigator, his/her family members, employees, and other dependent persons

Where

1 study site

FacilityCityRegionCountry
Psychiatrische Universitätsklinik ZürichZurichCanton of ZurichSwitzerland

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT06081179 on ClinicalTrials.gov →

Last updated in the registry 2025-11-19. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits