Does stimulation of the serotonin system increase prosocial behavior? A comparative pharmacological neuroscience study with healthy individuals
Zusammenfassung der Studie
In this study, we aim to investigate whether stimulation of the serotonin system with psychedelic substances has a lasting effect on social behavior. By social behavior, we mean aspects such as empathy, morality, trust, selflessness, compassion, or even the size and quality of a social environment. We will compare the two psychedelic substances MDMA and psilocybin with the non-psychedelic substance methylphenidate.
In total, we will include 120 healthy study participants. They will be randomly divided into three groups (MDMA, psilocybin, and methylphenidate).
The study consists of three appointments. At the first appointment, a medical health check will be conducted, and it will be verified whether a person is suitable to participate in the study. Additionally, baseline assessments of social behavior will be conducted through tasks and questionnaires on the computer. At the second appointment, the study participants will receive either MDMA, psilocybin, or methylphenidate, without knowing which substance it is (blinding). The examiner also does not know who receives which substance (double-blinding). Four weeks later, the third appointment will follow, during which further assessments of social behavior will be conducted through tasks and questionnaires on the computer. Three months after the study ends, we will send the study participants additional questionnaires that they can fill out online on a voluntary basis.
(BASEC)
Untersuchte Intervention
The study investigates whether stimulation of the serotonin system can increase prosocial behavior in the long term. This is explored through the intake of different substances, some of which are psychedelic. As an intervention, the study participants will receive one of three substances orally in capsule form: MDMA (100 mg), psilocybin (15 mg), or methylphenidate (60 mg).
MDMA ("Ecstasy") has a serotonergic, noradrenergic, and dopaminergic effect. Psilocybin ("Magic Mushrooms") is a classic psychedelic and has a serotonergic effect. Methylphenidate (Ritalin®), which is used as an active placebo, has a noradrenergic and dopaminergic effect.
(BASEC)
Untersuchte Krankheit(en)
The study investigates whether stimulation of the serotonin system can increase prosocial behavior in healthy individuals. Consequently, only healthy individuals will be included in the study.
(BASEC)
- Healthy study participants aged between 18 and 40 years
- Ability to read, understand, and provide written consent after information
(BASEC)
Ausschlusskriterien
- Pregnant or breastfeeding women
- Personal history of a severe psychiatric disorder (e.g., severe depression, bipolar disorder, psychotic disorder) according to the DSM-V definition and somatic diseases (e.g., cardiovascular problems, uncorrected low or high blood pressure) and family history of a psychotic disorder (e.g., bipolar disorder, psychotic disorder, schizophrenia) according to the DSM-V definition
- Current psychopharmacological treatment/intake of medications
(BASEC)
Studienstandort
Zürich
(BASEC)
Sponsor
PD Dr. med. Marcus Herdener
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Lydia Belinger
+41 (0)58 384 34 15
studie.2asc@clutterbli.uzh.chDepartment of Adult Psychiatry and Psychotherapy Pharmaco-Neuroimaging and Cognitive-Emotional Processing Addictive Disorders Psychiatric Hospital, University of Zurich
(BASEC)
Wissenschaftliche Auskünfte
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Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Zürich
(BASEC)
Datum der Bewilligung durch die Ethikkommission
17.02.2023
(BASEC)
ICTRP Studien-ID
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Offizieller Titel (Genehmigt von der Ethikkommission)
Does serotonin system stimulation increase pro-social behavior? - A comparative pharmacological neuroscientific study in healthy humans (BASEC)
Wissenschaftlicher Titel
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Öffentlicher Titel
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Untersuchte Krankheit(en)
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Untersuchte Intervention
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Studientyp
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Studiendesign
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Ein-/Ausschlusskriterien
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Primäre und sekundäre Endpunkte
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Registrierungsdatum
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Einschluss des ersten Teilnehmers
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Sekundäre Sponsoren
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Weitere Kontakte
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Sekundäre IDs
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Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
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Weitere Informationen zur Studie
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Ergebnisse der Studie
Zusammenfassung der Ergebnisse
lay-summary-2asc.pdfLink zu den Ergebnissen im Primärregister
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