Neurodynamics of Prosocial Emotional Processing Following Serotonergic Stimulation With N,N-Dimethyltryptamine (DMT) and Harmine in Healthy Subjects
Early Phase 1
Completed
- Conditions
- EmotionsMoodEmpathyCognitive Function 1, Social
- Interventions
- Registration Number
- NCT04716335
- Lead Sponsor
- Psychiatric University Hospital, Zurich
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 34
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Harmine + Placebo(DMT) Placebo (DMT) - Placebo(Harmin & Placebo) Placebo (DMT) - Harmine + DMT DMT - Placebo(Harmin & Placebo) Placebo (Harmine) - Harmine + DMT Harmine - Harmine + Placebo(DMT) Harmine -
- Primary Outcome Measures
Name Time Method Change in Behavioral Outcome Measures (Social Value Orientation - SVO, Charity Donation Frank Task) Acute drug effects (240 minutes - Charity Donation Frank Task, 300 minutes - SVO) Social Cognition
Change in Behavioral Outcome Measures (Visuall Oddball, Karaoke Task) Acute drug effects (60 min - Visuall Oddball, 150 min - Karaoke Task) Self-referential Processing
Change in Pharmacological-EEG (Lagged Phase Synchronicity) Baseline, Acute drug effects (30 minutes , 135 minutes, 195 minutes, 285 minutes) Functional brain connectivity
Change in Pharmacological-EEG (Resting State) Baseline, Acute drug effects (30 minutes , 135 minutes, 195 minutes, 285 minutes) Spectral Density
Change in Pharmacological-EEG Acute drug effects (60 minutes, 240 minutes) Event-Related Potentials (ERP)
- Secondary Outcome Measures
Name Time Method Change in biomarkers Baseline, Acute drug effects (30 minutes, 90 minutes, 150 minutes, 300 minutes) Oxidative Stress Markers (Nitric Oxide Synthase)
Psychometry Baseline, Acute, 1 day after, 1 week after, 1 month after and 4 month after intervention MBQ
Trial Locations
- Locations (1)
Psychiatric University Hospital
🇨ðŸ‡Zürich, Switzerland