Emotions, Mood, Cognitive Function 1, Social, Empathy
Conditions
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.
Interventions
DRUGDMT
DMT
DRUGHarmine
Harmine
DRUGPlacebo (Harmine)
Placebo for Harmine
DRUGPlacebo (DMT)
Placebo for DMT
Sponsors
University of Basel
Psychiatric University Hospital, Zurich
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
20 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 (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) |
| 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 Pharmacological-EEG (Lagged Phase Synchronicity) | Baseline, Acute drug effects (30 minutes , 135 minutes, 195 minutes, 285 minutes) | Functional brain connectivity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Psychometry | Baseline, Acute, 1 day after, 1 week after, 1 month after and 4 month after intervention | Cognitive Flexibility |
| Change in biomarkers | 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) |
Countries
Switzerland
Outcome results
None listed