Does stimulation of the serotonin system increase prosocial behavior? A comparative pharmacological neuroscience study with healthy individuals
Résumé de l'étude
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 étudiée
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)
Maladie en cours d'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)
Critères d'exclusion
- 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)
Lieu de l’étude
Zurich
(BASEC)
Sponsor
PD Dr. med. Marcus Herdener
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
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)
Informations générales
058 384 34 15058 384 34 15
studie.2asc@clutterbli.uzh.chstudie.2asc@clutterbli.uzh.ch(ICTRP)
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale de Zurich
(BASEC)
Date d'approbation du comité d'éthique
17.02.2023
(BASEC)
Identifiant de l'essai ICTRP
NCT06081179 (ICTRP)
Titre officiel (approuvé par le comité d'éthique)
Does serotonin system stimulation increase pro-social behavior? - A comparative pharmacological neuroscientific study in healthy humans (BASEC)
Titre académique
Does Serotonin System Stimulation Increase Pro-social Behavior? - A Comparative Pharmacological Neuroscientific Study in Healthy Humans (ICTRP)
Titre public
Does Serotonin System Stimulation Increase Pro-social Behavior? - A Comparative Pharmacological Neuroscientific Study in Healthy Humans (ICTRP)
Maladie en cours d'investigation
Healthy (ICTRP)
Intervention étudiée
Drug: PsilocybinDrug: 3,4 MethylenedioxymethamphetamineDrug: Methylphenidate (ICTRP)
Type d'essai
Interventional (ICTRP)
Plan de l'étude
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Basic Science. Masking: Double (Participant, Investigator). (ICTRP)
Critères d'inclusion/exclusion
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 (ICTRP)
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Critères d'évaluation principaux et secondaires
Multifaceted Empathy Test;Moral Inference Task;Zurich Prosocial Game;Social Gaze Task;Moral Expansion Task;Social Network Questionnaire;Pro-social Voting Behavior;Oxford Utilitarianism Scale;Compassion Scale;Inclusion of others in the self (ICTRP)
5-Dimensional Altered States of Consciousness Rating Scale;5-Dimensional Altered States of Consciousness Rating Scale short;Mystical Experience Questionnaire;Persisting Effects Questionnaire;Epistemic and personal transformation (pre and post versions);Symptom Checklist 90-R;The Positive and Negative Affect Schedule;FEELINGS;Ego Consciousness Change of Perspective Questionnaire (1 & 2) (ICTRP)
Date d'enregistrement
non disponible
Inclusion du premier participant
non disponible
Sponsors secondaires
non disponible
Contacts supplémentaires
Lydia Belinger;Lydia Belinger, studie.2asc@bli.uzh.ch, 058 384 34 15;058 384 34 15 (ICTRP)
ID secondaires
2A-SC-1 (ICTRP)
Résultats-Données individuelles des participants
non disponible
Informations complémentaires sur l'essai
https://clinicaltrials.gov/study/NCT06081179 (ICTRP)
Résultats de l'essai
Résumé des résultats
non disponible
Lien vers les résultats dans le registre primaire
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