Does stimulation of the serotonin system increase prosocial behavior? A comparative pharmacological neuroscience study with healthy individuals
Summary description of the study
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)
Intervention under investigation
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)
Disease under investigation
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)
Exclusion criteria
- 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)
Trial sites
Zurich
(BASEC)
Sponsor
PD Dr. med. Marcus Herdener
(BASEC)
Contact
Contact Person Switzerland
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)
Scientific Information
not available
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Zurich
(BASEC)
Date of authorisation
17.02.2023
(BASEC)
ICTRP Trial ID
not available
Official title (approved by ethics committee)
Does serotonin system stimulation increase pro-social behavior? - A comparative pharmacological neuroscientific study in healthy humans (BASEC)
Academic title
not available
Public title
not available
Disease under investigation
not available
Intervention under investigation
not available
Type of trial
not available
Trial design
not available
Inclusion/Exclusion criteria
not available
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Primary and secondary end points
not available
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Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
not available
Additional contacts
not available
Secondary trial IDs
not available
Results-Individual Participant Data (IPD)
not available
Further information on the trial
not available
Results of the trial
Results summary
not available
Link to the results in the primary register
not available