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

Mood Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04716335
• Other study ID #: 2018-01385
• Status: Completed
• Phase: Early Phase 1
• Start date: December 1, 2020
• Est. completion date: January 10, 2022

Study information

• Verified date: October 2022
• Source: Psychiatric University Hospital, Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: January 10, 2022
• Est. primary completion date: July 19, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• DMT
DMT
• Harmine
Harmine
• Placebo (Harmine)
Placebo for Harmine
• Placebo (DMT)
Placebo for DMT

Locations

Country	Name	City	State
Switzerland	Psychiatric University Hospital	Zürich

Sponsors (2)

Lead Sponsor	Collaborator
Psychiatric University Hospital, Zurich	University of Basel

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Behavioral Outcome Measures (Social Value Orientation - SVO, Charity Donation Frank Task)	Social Cognition	Acute drug effects (240 minutes - Charity Donation Frank Task, 300 minutes - SVO)
Primary	Change in Behavioral Outcome Measures (Visuall Oddball, Karaoke Task)	Self-referential Processing	Acute drug effects (60 min - Visuall Oddball, 150 min - Karaoke Task)
Primary	Change in Pharmacological-EEG (Lagged Phase Synchronicity)	Functional brain connectivity	Baseline, Acute drug effects (30 minutes , 135 minutes, 195 minutes, 285 minutes)
Primary	Change in Pharmacological-EEG (Resting State)	Spectral Density	Baseline, Acute drug effects (30 minutes , 135 minutes, 195 minutes, 285 minutes)
Primary	Change in Pharmacological-EEG	Event-Related Potentials (ERP)	Acute drug effects (60 minutes, 240 minutes)
Secondary	Change in biomarkers	Tryptophan catabolites (TRYCAT)	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)
Secondary	Change in biomarkers	Brain-derived Neurotrophic Factor (BDNF)	Baseline, Acute drug effects (30 minutes, 90 minutes, 150 minutes, 300 minutes)
Secondary	Change in biomarkers	Hypothalamic-Pituitary-Adrenal Axis (HPA-A)	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)
Secondary	Change in biomarkers	API (DMT, Harmine)	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)
Secondary	Change in biomarkers	Neuroinflammation - Interleukines	Baseline, Acute drug effects (30 minutes, 90 minutes, 150 minutes, 300 minutes)
Secondary	Change in biomarkers	Oxidative Stress Markers (Nitric Oxide Synthase)	Baseline, Acute drug effects (30 minutes, 90 minutes, 150 minutes, 300 minutes)
Secondary	Psychometry	Cognitive Flexibility	Baseline, Acute, 1 day after, 1 week after, 1 month after and 4 month after intervention
Secondary	Psychometry	MINDSENS	Baseline, Acute, 1 day after, 1 week after, 1 month after and 4 month after intervention
Secondary	Psychometry	PANAS	Baseline, Acute, 1 day after, 1 week after, 1 month after and 4 month after intervention
Secondary	Psychometry	CFI	Baseline, Acute, 1 day after, 1 week after, 1 month after and 4 month after intervention
Secondary	Psychometry	SRQ	Baseline, Acute, 1 day after, 1 week after, 1 month after and 4 month after intervention
Secondary	Psychometry	MBQ	Baseline, Acute, 1 day after, 1 week after, 1 month after and 4 month after intervention