Neurodynamics of Prosocial Emotional Processing Following Serotonergic Stimulation With N,N-Dimethyltryptamine (DMT) and Harmine in Healthy Subjects
Overview
- Phase
- Early Phase 1
- Intervention
- DMT
- Conditions
- Emotions
- Sponsor
- Psychiatric University Hospital, Zurich
- Enrollment
- 34
- Locations
- 1
- Primary Endpoint
- Change in Behavioral Outcome Measures (Social Value Orientation - SVO, Charity Donation Frank Task)
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
Milan Scheidegger
Principal Investigator
Psychiatric University Hospital, Zurich
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
Arms & Interventions
Harmine + DMT
Intervention: DMT
Harmine + DMT
Intervention: Harmine
Harmine + Placebo(DMT)
Intervention: Harmine
Harmine + Placebo(DMT)
Intervention: Placebo (DMT)
Placebo(Harmin & Placebo)
Intervention: Placebo (Harmine)
Placebo(Harmin & Placebo)
Intervention: Placebo (DMT)
Outcomes
Primary Outcomes
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
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
Change in Pharmacological-EEG (Lagged Phase Synchronicity)
Time Frame: Baseline, Acute drug effects (30 minutes , 135 minutes, 195 minutes, 285 minutes)
Functional brain connectivity
Change in Pharmacological-EEG (Resting State)
Time Frame: Baseline, Acute drug effects (30 minutes , 135 minutes, 195 minutes, 285 minutes)
Spectral Density
Change in Pharmacological-EEG
Time Frame: Acute drug effects (60 minutes, 240 minutes)
Event-Related Potentials (ERP)
Secondary Outcomes
- Change in biomarkers(Baseline, Acute drug effects (30 minutes, 90 minutes, 150 minutes, 300 minutes))
- Psychometry(Baseline, Acute, 1 day after, 1 week after, 1 month after and 4 month after intervention)