Neuropsychopharmacological Influence of Pharmahuasca on Theory-of-Mind Processes in Healthy Subjects
Summary description of the study
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 under investigation
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)
Disease under investigation
Neuropsychological Basic Research
(BASEC)
- Subjects aged 25-45 years - Physical and mental health - Good German language skills (BASEC)
Exclusion criteria
- 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)
Trial sites
Zurich
(BASEC)
Sponsor
not available
Contact
Contact Person Switzerland
Dr. Dr. Milan Scheidegger (Co-Investigator)
+41 79 436 13 92
milan.scheidegger@clutterbli.uzh.ch(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
19.08.2022
(BASEC)
ICTRP Trial ID
not available
Official title (approved by ethics committee)
not available
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
not available
Primary and secondary end points
not available
not available
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