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| Name | Class |
|---|---|
| University of Basel | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Harmine + DMT | Experimental |
| |
| Harmine + Placebo(DMT) | Experimental |
| |
| Placebo(Harmin & Placebo) | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DMT | Drug | DMT |
| |
| Harmine |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Change in Behavioral Outcome Measures (Visuall Oddball, Karaoke Task) | Self-referential Processing | Acute drug effects (60 min - Visuall Oddball, 150 min - Karaoke Task) |
| Change in Pharmacological-EEG (Lagged Phase Synchronicity) | Functional brain connectivity | Baseline, Acute drug effects (30 minutes , 135 minutes, 195 minutes, 285 minutes) |
| Change in Pharmacological-EEG (Resting State) | Spectral Density | Baseline, Acute drug effects (30 minutes , 135 minutes, 195 minutes, 285 minutes) |
| Change in Pharmacological-EEG | Event-Related Potentials (ERP) | Acute drug effects (60 minutes, 240 minutes) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Change in biomarkers |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Psychiatric University Hospital | Zurich | 8032 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39774840 | Derived | Mueller MJ, Aicher HD, Dornbierer DA, Marten L, Suay D, Meling D, Elsner C, Wicki IA, Muller J, Poetzsch SN, Caflisch L, Hempe A, Steinhart CP, Puchkov M, Kost J, Landolt HP, Seifritz E, Quednow BB, Scheidegger M. Pharmacokinetics and pharmacodynamics of an innovative psychedelic N,N-dimethyltryptamine/harmine formulation in healthy participants: a randomized controlled trial. Int J Neuropsychopharmacol. 2024 Dec 28;28(1):pyaf001. doi: 10.1093/ijnp/pyaf001. | |
| 38089057 |
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| Drug |
Harmine |
|
| Placebo (Harmine) | Drug | Placebo for Harmine |
|
| Placebo (DMT) | Drug | Placebo for DMT |
|
Brain-derived Neurotrophic Factor (BDNF)
| Baseline, Acute drug effects (30 minutes, 90 minutes, 150 minutes, 300 minutes) |
| 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) |
| 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) |
| Change in biomarkers | Neuroinflammation - Interleukines | Baseline, Acute drug effects (30 minutes, 90 minutes, 150 minutes, 300 minutes) |
| Change in biomarkers | Oxidative Stress Markers (Nitric Oxide Synthase) | Baseline, Acute drug effects (30 minutes, 90 minutes, 150 minutes, 300 minutes) |
| Psychometry | Cognitive Flexibility | Baseline, Acute, 1 day after, 1 week after, 1 month after and 4 month after intervention |
| Psychometry | MINDSENS | Baseline, Acute, 1 day after, 1 week after, 1 month after and 4 month after intervention |
| Psychometry | PANAS | Baseline, Acute, 1 day after, 1 week after, 1 month after and 4 month after intervention |
| Psychometry | CFI | Baseline, Acute, 1 day after, 1 week after, 1 month after and 4 month after intervention |
| Psychometry | SRQ | Baseline, Acute, 1 day after, 1 week after, 1 month after and 4 month after intervention |
| Psychometry | MBQ | Baseline, Acute, 1 day after, 1 week after, 1 month after and 4 month after intervention |
| Derived |
| Dornbierer DA, Marten L, Mueller J, Aicher HD, Mueller MJ, Boxler M, Kometer M, Kosanic D, von Rotz R, Puchkov M, Kraemer T, Landolt HP, Seifritz E, Scheidegger M. Overcoming the clinical challenges of traditional ayahuasca: a first-in-human trial exploring novel routes of administration of N,N-Dimethyltryptamine and harmine. Front Pharmacol. 2023 Nov 27;14:1246892. doi: 10.3389/fphar.2023.1246892. eCollection 2023. |
| ID | Term |
|---|---|
| D006247 | Harmine |
| D004130 | N,N-Dimethyltryptamine |
| ID | Term |
|---|---|
| D000077290 | Harmala Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D002243 | Carbolines |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D014363 | Tryptamines |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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