Neurodynamics of Prosocial Emotional Processing Following Serotonergic Stimulation With N,N-Dimethyltryptamine (DMT) and Harmine in Healthy Subjects

DMT

Brief Summary

The aim of the project is to assess brain network dynamics, self-referential information processing and prosociality and learning following the modulation of the serotonin-system by serotonergic-psychoactive compounds.

Intervention / Treatment

  • DMT (DRUG)
  • Harmine (DRUG)
  • Placebo (Harmine) (DRUG)
    Placebo for Harmine
  • Placebo (DMT) (DRUG)
    Placebo for DMT

Condition or Disease

  • Emotions
  • Mood
  • Cognitive Function 1, Social
  • Empathy

Phase

  • Early Phase 1

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 20 Years to 40 Years
    Enrollment: 34 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Basic Science

    Masking

    QUADRUPLE:
    • Participant
    • Care Provider
    • Investigator
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Dec 01, 2020 ACTUAL
    Primary Completion: Jul 19, 2021 ACTUAL
    Completion Date: Jan 10, 2022 ACTUAL
    Study First Posted: Jan 20, 2021 ACTUAL
    Last Updated: Oct 03, 2022

    Sponsors / Collaborators

    Lead Sponsor: Psychiatric University Hospital, Zurich
    Responsible Party: Milan Scheidegger

    Location

    Zürich, Switzerland

    Participant Groups

    • No description provided

    • No description provided

    • No description provided

    Eligibility Criteria

    Sex: Male
    Minimum Age: 20
    Maximum Age: 40
    Age Groups: Adult
    Healthy Volunteers: Yes

    Inclusion Criteria:

    * Willing and capable to give informed consent for the participation in the study after it has been thoroughly explained
    * Little or no previous experiences with psychedelic substances
    * Body mass index (BMI) between 18.5 and 25
    * Willing to refrain from drinking caffeine 3 days and alcohol the day before testing session, from drinking alcohol and caffeinated drinks at the testing days and from consuming psychoactive substances or other medications for 2 weeks before testing days and for the duration of the study
    * Able and willing to comply with all study requirements
    * Informed consent form was signed
    * Good knowledge of the German language

    Exclusion Criteria:

    * Previous significant adverse response to a hallucinogenic drug
    * Participation in another study where pharmaceutical compounds will be given
    * Self or first-degree relatives with present or antecedent psychiatric disorders
    * History of head trauma or fainting
    * Recent cardiac or brain surgery
    * Current use of medication or psychotropic substances (including nicotine addiction)
    * Presence of major internal or neurological disorders (including sepsis, pheochromocytoma, thyrotoxicosis, drug-induced fibrosis, familiar or basilar artery migraine)
    * Cardiovascular disease (hypertonia, coronary artery disease, heart insufficiency, myocardial infarction, coronary spastic angina)
    * Peripheral vascular disease (thromboangiitis obliterans, luetic arteritis, severe arteriosclerosis, thrombophlebitis, Raynaud's disease)
    * Liver or renal disease

    Primary Outcomes

    • Social Cognition

    • Self-referential Processing

    • Functional brain connectivity

    • Spectral Density

    • Event-Related Potentials (ERP)

    Secondary Outcomes

    • Tryptophan catabolites (TRYCAT)

    • Brain-derived Neurotrophic Factor (BDNF)

    • Hypothalamic-Pituitary-Adrenal Axis (HPA-A)

    • API (DMT, Harmine)

    • Neuroinflammation - Interleukines

    • Oxidative Stress Markers (Nitric Oxide Synthase)

    • Cognitive Flexibility

    • MINDSENS

    • PANAS

    • CFI

    • SRQ

    • MBQ

    More Details

    NCT Number: NCT04716335
    Other IDs: 2018-01385
    Study URL: https://clinicaltrials.gov/study/NCT04716335
    Last updated: Sep 29, 2023