Clinical trial NCT04716335: Neurodynamics of Prosocial Emotional Processing Following Serotonergic Stimulation With N,N-Dimethyltryptamine (DMT) and Harmine in Healthy Subjects
Official title: Neurodynamics of Prosocial Emotional Processing Following Serotonergic Stimulation With N,N-Dimethyltryptamine (DMT) and Harmine in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Emotions
Mood
Cognitive Function 1, Social
Empathy
Lead sponsor: Psychiatric University Hospital, Zurich
Sponsor class: OTHER
Collaborators: name: University of Basel
First posted: 2021-01-20
Enrollment: 34
Sex: MALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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:
measure: Change in Behavioral Outcome Measures (Social Value Orientation - SVO, Charity Donation Frank Task)
timeFrame: Acute drug effects (240 minutes - Charity Donation Frank Task, 300 minutes - SVO)
measure: Change in Behavioral Outcome Measures (Visuall Oddball, Karaoke Task)
timeFrame: Acute drug effects (60 min - Visuall Oddball, 150 min - Karaoke Task)
measure: Change in Pharmacological-EEG (Lagged Phase Synchronicity)
timeFrame: Baseline, Acute drug effects (30 minutes , 135 minutes, 195 minutes, 285 minutes)
measure: Change in Pharmacological-EEG (Resting State)
timeFrame: Baseline, Acute drug effects (30 minutes , 135 minutes, 195 minutes, 285 minutes)
measure: Change in Pharmacological-EEG
timeFrame: Acute drug effects (60 minutes, 240 minutes)
Secondary outcomes:
measure: Change in biomarkers
timeFrame: 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)
measure: Change in biomarkers
timeFrame: Baseline, Acute drug effects (30 minutes, 90 minutes, 150 minutes, 300 minutes)
measure: Change in biomarkers
timeFrame: 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)
measure: Change in biomarkers
timeFrame: 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)
measure: Change in biomarkers
timeFrame: Baseline, Acute drug effects (30 minutes, 90 minutes, 150 minutes, 300 minutes)
measure: Change in biomarkers
timeFrame: Baseline, Acute drug effects (30 minutes, 90 minutes, 150 minutes, 300 minutes)
measure: Psychometry
timeFrame: Baseline, Acute, 1 day after, 1 week after, 1 month after and 4 month after intervention
measure: Psychometry
timeFrame: Baseline, Acute, 1 day after, 1 week after, 1 month after and 4 month after intervention
measure: Psychometry
timeFrame: Baseline, Acute, 1 day after, 1 week after, 1 month after and 4 month after intervention
measure: Psychometry
timeFrame: Baseline, Acute, 1 day after, 1 week after, 1 month after and 4 month after intervention
measure: Psychometry
timeFrame: Baseline, Acute, 1 day after, 1 week after, 1 month after and 4 month after intervention
measure: Psychometry
timeFrame: Baseline, Acute, 1 day after, 1 week after, 1 month after and 4 month after intervention
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: Psychiatric University Hospital
Study officials:
References: