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Completed

NCT Number: NCT04716335

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

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.

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Key information

Age range

20 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Early Phase 1

Primary location

Psychiatric University Hospital

Zurich, 8032, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DMT

Drug

DMT

Harmine

Drug

Harmine

Placebo (Harmine)

Drug

Placebo for Harmine

Placebo (DMT)

Drug

Placebo for DMT

Primary outcomes

  1. Change in Behavioral Outcome Measures (Social Value Orientation - SVO, Charity Donation Frank Task)

    Time frame: Acute drug effects (240 minutes - Charity Donation Frank Task, 300 minutes - SVO)

    Social Cognition

  2. Change in Behavioral Outcome Measures (Visuall Oddball, Karaoke Task)

    Time frame: Acute drug effects (60 min - Visuall Oddball, 150 min - Karaoke Task)

    Self-referential Processing

  3. Change in Pharmacological-EEG (Lagged Phase Synchronicity)

    Time frame: Baseline, Acute drug effects (30 minutes , 135 minutes, 195 minutes, 285 minutes)

    Functional brain connectivity

  4. Change in Pharmacological-EEG (Resting State)

    Time frame: Baseline, Acute drug effects (30 minutes , 135 minutes, 195 minutes, 285 minutes)

    Spectral Density

  5. Change in Pharmacological-EEG

    Time frame: Acute drug effects (60 minutes, 240 minutes)

    Event-Related Potentials (ERP)

Secondary outcomes

  1. Change in biomarkers

    Time frame: Baseline, Acute drug effects (0 minutes, 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes, 210 minutes, 240 minutes, 270 minutes, 300 minutes)

    Tryptophan catabolites (TRYCAT)

  2. Change in biomarkers

    Time frame: Baseline, Acute drug effects (30 minutes, 90 minutes, 150 minutes, 300 minutes)

    Brain-derived Neurotrophic Factor (BDNF)

  3. Change in biomarkers

    Time frame: Baseline, Acute drug effects (0 minutes, 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes, 210 minutes, 240 minutes, 270 minutes, 300 minutes)

    Hypothalamic-Pituitary-Adrenal Axis (HPA-A)

  4. Change in biomarkers

    Time frame: Baseline, Acute drug effects (0 minutes, 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes, 210 minutes, 240 minutes, 270 minutes, 300 minutes)

    API (DMT, Harmine)

  5. Change in biomarkers

    Time frame: Baseline, Acute drug effects (30 minutes, 90 minutes, 150 minutes, 300 minutes)

    Neuroinflammation - Interleukines

  6. Change in biomarkers

    Time frame: Baseline, Acute drug effects (30 minutes, 90 minutes, 150 minutes, 300 minutes)

    Oxidative Stress Markers (Nitric Oxide Synthase)

  7. Psychometry

    Time frame: Baseline, Acute, 1 day after, 1 week after, 1 month after and 4 month after intervention

    Cognitive Flexibility

  8. Psychometry

    Time frame: Baseline, Acute, 1 day after, 1 week after, 1 month after and 4 month after intervention

    MINDSENS

  9. Psychometry

    Time frame: Baseline, Acute, 1 day after, 1 week after, 1 month after and 4 month after intervention

    PANAS

  10. Psychometry

    Time frame: Baseline, Acute, 1 day after, 1 week after, 1 month after and 4 month after intervention

    CFI

  11. Psychometry

    Time frame: Baseline, Acute, 1 day after, 1 week after, 1 month after and 4 month after intervention

    SRQ

  12. Psychometry

    Time frame: Baseline, Acute, 1 day after, 1 week after, 1 month after and 4 month after intervention

    MBQ

Sponsors and collaborators

Lead sponsor

Psychiatric University Hospital, Zurich

Other

Collaborators

  • University of Basel

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Jan 20, 2021
Registry last updated
Oct 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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