- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04716335
Neurodynamics of Prosocial Emotional Processing Following Serotonergic Stimulation With N,N-Dimethyltryptamine (DMT) and Harmine in Healthy Subjects
October 3, 2022 updated by: Milan Scheidegger, Psychiatric University Hospital, Zurich
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
34
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Zürich, Switzerland, 8032
- Psychiatric University Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 40 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Harmine + DMT
|
DMT
Harmine
|
Experimental: Harmine + Placebo(DMT)
|
Harmine
Placebo for DMT
|
Placebo Comparator: Placebo(Harmin & Placebo)
|
Placebo for DMT
Placebo for Harmine
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Acute drug effects (240 minutes - Charity Donation Frank Task, 300 minutes - SVO)
|
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
|
Acute drug effects (60 min - Visuall Oddball, 150 min - Karaoke Task)
|
Change in Pharmacological-EEG (Lagged Phase Synchronicity)
Time Frame: Baseline, Acute drug effects (30 minutes , 135 minutes, 195 minutes, 285 minutes)
|
Functional brain connectivity
|
Baseline, Acute drug effects (30 minutes , 135 minutes, 195 minutes, 285 minutes)
|
Change in Pharmacological-EEG (Resting State)
Time Frame: Baseline, Acute drug effects (30 minutes , 135 minutes, 195 minutes, 285 minutes)
|
Spectral Density
|
Baseline, Acute drug effects (30 minutes , 135 minutes, 195 minutes, 285 minutes)
|
Change in Pharmacological-EEG
Time Frame: Acute drug effects (60 minutes, 240 minutes)
|
Event-Related Potentials (ERP)
|
Acute drug effects (60 minutes, 240 minutes)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in biomarkers
Time Frame: 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)
|
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
Time Frame: Baseline, Acute drug effects (30 minutes, 90 minutes, 150 minutes, 300 minutes)
|
Brain-derived Neurotrophic Factor (BDNF)
|
Baseline, Acute drug effects (30 minutes, 90 minutes, 150 minutes, 300 minutes)
|
Change in biomarkers
Time Frame: 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)
|
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
Time Frame: 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)
|
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
Time Frame: Baseline, Acute drug effects (30 minutes, 90 minutes, 150 minutes, 300 minutes)
|
Neuroinflammation - Interleukines
|
Baseline, Acute drug effects (30 minutes, 90 minutes, 150 minutes, 300 minutes)
|
Change in biomarkers
Time Frame: Baseline, Acute drug effects (30 minutes, 90 minutes, 150 minutes, 300 minutes)
|
Oxidative Stress Markers (Nitric Oxide Synthase)
|
Baseline, Acute drug effects (30 minutes, 90 minutes, 150 minutes, 300 minutes)
|
Psychometry
Time Frame: Baseline, Acute, 1 day after, 1 week after, 1 month after and 4 month after intervention
|
Cognitive Flexibility
|
Baseline, Acute, 1 day after, 1 week after, 1 month after and 4 month after intervention
|
Psychometry
Time Frame: Baseline, Acute, 1 day after, 1 week after, 1 month after and 4 month after intervention
|
MINDSENS
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Baseline, Acute, 1 day after, 1 week after, 1 month after and 4 month after intervention
|
Psychometry
Time Frame: Baseline, Acute, 1 day after, 1 week after, 1 month after and 4 month after intervention
|
PANAS
|
Baseline, Acute, 1 day after, 1 week after, 1 month after and 4 month after intervention
|
Psychometry
Time Frame: Baseline, Acute, 1 day after, 1 week after, 1 month after and 4 month after intervention
|
CFI
|
Baseline, Acute, 1 day after, 1 week after, 1 month after and 4 month after intervention
|
Psychometry
Time Frame: Baseline, Acute, 1 day after, 1 week after, 1 month after and 4 month after intervention
|
SRQ
|
Baseline, Acute, 1 day after, 1 week after, 1 month after and 4 month after intervention
|
Psychometry
Time Frame: Baseline, Acute, 1 day after, 1 week after, 1 month after and 4 month after intervention
|
MBQ
|
Baseline, Acute, 1 day after, 1 week after, 1 month after and 4 month after intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2020
Primary Completion (Actual)
July 19, 2021
Study Completion (Actual)
January 10, 2022
Study Registration Dates
First Submitted
December 23, 2020
First Submitted That Met QC Criteria
January 15, 2021
First Posted (Actual)
January 20, 2021
Study Record Updates
Last Update Posted (Actual)
October 4, 2022
Last Update Submitted That Met QC Criteria
October 3, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018-01385
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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