Neuropsychopharmacological Influence of Pharmahuasca on Theory-of-Mind Processes in Healthy Subjects
Descrizione riassuntiva dello studio
The aim of this study is to investigate the pharmacokinetic and pharmacodynamic properties of DMT and Harmin ("Pharmahuasca") and the effect of the psychedelic experience on behavioral parameters of the "Theory of Mind". Furthermore, we examine whether this form of administration of DMT and Harmin is suitable for use in a group setting, which could also be implemented in subsequent clinical studies. We evaluate the feasibility of this approach using coaching elements from Acceptance and Commitment Therapy (ACT), which will be offered as preparatory psychoeducation for study participants. By taking blood samples, continuously measuring vital parameters, and quantifying relevant metabolites, additional pharmacokinetic and pharmacodynamic data will be collected for further correlation analyses with behavioral data. We use a novel behavioral experiment to investigate the influence of DMT and Harmin on vividness, intentionality, and experienced connectedness to various stimuli while study participants view naturalistic images. These behavioral data will be collected during the acute effects of the psychopharmacological stimulation and analyzed within the framework of behavioral psychology. 48 healthy subjects will be randomly assigned, taking into account age and sex, to one of 2 dose groups (high dose and low dose). The study will be conducted in smaller cohorts consisting of 6 people. Each cohort will consist of 3 people from the high dose condition and 3 people from the low dose condition. The subjects will undergo 2 testing days + one preparation meeting + one follow-up meeting in the group.
(BASEC)
Intervento studiato
A substance combination consisting of DMT and Harmin (known as Pharmahuasca) is being investigated. On Day 1, up to 100 mg of DMT/Harmin will be administered, on Day 2 between 80-120 mg of DMT/Harmin.
(BASEC)
Malattie studiate
Neuropsychological Basic Research
(BASEC)
- Subjects aged 25-45 years - Physical and mental health - Good German language skills (BASEC)
Criteri di esclusione
- Simultaneous participation in other studies with pharmacological intervention - Intake of certain psychoactive medications/drugs up to 2 weeks prior to the study start and during the study duration - Certain psychiatric disorders in the personal history or in first-degree relatives (BASEC)
Luogo dello studio
Zurigo
(BASEC)
Sponsor
non disponibile
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Dr. Dr. Milan Scheidegger (Co-Investigator)
+41 79 436 13 92
milan.scheidegger@clutterbli.uzh.ch(BASEC)
Informazioni scientifiche
non disponibile
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione etica Zurigo
(BASEC)
Data di approvazione del comitato etico
19.08.2022
(BASEC)
ID di studio ICTRP
non disponibile
Titolo ufficiale (approvato dal comitato etico)
non disponibile
Titolo accademico
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Intervento studiato
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Tipo di studio
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Disegno dello studio
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Criteri di inclusione/esclusione
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non disponibile
Endpoint primari e secondari
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Data di registrazione
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Inclusione del primo partecipante
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Sponsor secondari
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Contatti aggiuntivi
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ID secondari
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Risultati-Dati individuali dei partecipanti
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Ulteriori informazioni sullo studio
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Risultati dello studio
Riepilogo dei risultati
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Link ai risultati nel registro primario
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