Neuropsychopharmacological Influence of Pharmahuasca on Theory-of-Mind Processes in Healthy Subjects
Résumé de l'étude
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)
Intervention étudiée
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)
Maladie en cours d'investigation
Neuropsychological Basic Research
(BASEC)
- Subjects aged 25-45 years - Physical and mental health - Good German language skills (BASEC)
Critères d'exclusion
- 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)
Lieu de l’étude
Zurich
(BASEC)
Sponsor
non disponible
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Dr. Dr. Milan Scheidegger (Co-Investigator)
+41 79 436 13 92
milan.scheidegger@clutterbli.uzh.ch(BASEC)
Informations scientifiques
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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
19.08.2022
(BASEC)
Identifiant de l'essai ICTRP
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Titre officiel (approuvé par le comité d'éthique)
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Titre académique
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Titre public
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Maladie en cours d'investigation
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Intervention étudiée
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Type d'essai
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Plan de l'étude
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Critères d'inclusion/exclusion
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Critères d'évaluation principaux et secondaires
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Date d'enregistrement
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Inclusion du premier participant
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Sponsors secondaires
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Contacts supplémentaires
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ID secondaires
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Résultats-Données individuelles des participants
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Informations complémentaires sur l'essai
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Résultats de l'essai
Résumé des résultats
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Lien vers les résultats dans le registre primaire
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