Investigating the effects of serotonin stimulation on social behavior in healthy individuals
Does Serotonin System Stimulation Increase Pro-social Behavior? - A Comparative Pharmacological Neuroscientific Study in Healthy Humans
This study is testing if taking certain psychedelic substances that boost serotonin can improve friendly behavior in healthy people compared to those that boost dopamine.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | All |
| Sponsor | University of Zurich Academic / other |
| Locations | 1 site (Zürich) |
| Trial ID | NCT06081179 on ClinicalTrials.gov |
What this trial studies
This study examines whether the administration of psychedelic substances that stimulate the serotonin system can enhance pro-social behavior compared to substances that stimulate the dopamine system in healthy participants. It aims to answer two main questions: whether serotonin stimulation leads to lasting changes in pro-social behavior and if these effects are unique to serotonergic stimulation. The study will utilize objective measures of pro-social cognition four weeks after participants receive pharmacological challenges with MDMA, psilocybin, or methylphenidate. Healthy volunteers aged 18-40 will be recruited for this phase 1 interventional study.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy males and females aged 18-40 who can provide informed consent and comply with study requirements.
Not a fit: Patients with unstable medical conditions or those who regularly use psychoactive substances may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into how serotonin stimulation may enhance social behaviors, potentially informing therapeutic approaches for social deficits.
How similar studies have performed: While the effects of psychedelics on behavior have been explored, this specific comparative approach to serotonin and dopamine stimulation in healthy individuals is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Zürich
- Psychiatrische Universitätsklinik Zürich — Zürich, Switzerland (Recruiting)
Study contacts
- Study coordinator: Lydia Belinger
- Email: studie.2asc@bli.uzh.ch
- Phone: 058 384 34 15
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.