Neurodynamics of Prosocial Emotional Processing Following Serotonergic Stimulation With N,N-Dimethyltryptamine (DMT) and Harmine in Healthy Subjects

• Sponsor: Psychiatric University Hospital, Zurich (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04716335
• Collaborator: University of Basel (Other)
• Enrollment: 34
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 12
• Patients Per Site Per Month: 2.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Emotions; Mood; Cognitive Function 1, Social; Empathy	Drug: DMT; Drug: Harmine; Drug: Placebo (Harmine); Drug: Placebo (DMT)	Early Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 34 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Basic Science
• Official Title: Neurodynamics of Prosocial Emotional Processing Following Serotonergic Stimulation With N,N-Dimethyltryptamine (DMT) and Harmine in Healthy Subjects
• Actual Study Start Date: Dec 1, 2020
• Actual Primary Completion Date: Jul 19, 2021
• Anticipated Study Completion Date: Nov 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Harmine + DMT	Drug: DMT; DMT; Drug: Harmine; Harmine
Experimental: Harmine + Placebo(DMT)	Drug: Harmine; Harmine; Drug: Placebo (DMT); Placebo for DMT
Placebo Comparator: Placebo(Harmin & Placebo)	Drug: Placebo (Harmine); Placebo for Harmine; Drug: Placebo (DMT); Placebo for DMT

Outcome Measures

Primary Outcome Measures

1. 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

2. Change in Behavioral Outcome Measures (Visuall Oddball, Karaoke Task) [Acute drug effects (60 min - Visuall Oddball, 150 min - Karaoke Task)]

   Self-referential Processing

3. Change in Pharmacological-EEG (Lagged Phase Synchronicity) [Baseline, Acute drug effects (30 minutes , 135 minutes, 195 minutes, 285 minutes)]

   Functional brain connectivity

4. Change in Pharmacological-EEG (Resting State) [Baseline, Acute drug effects (30 minutes , 135 minutes, 195 minutes, 285 minutes)]

   Spectral Density

5. Change in Pharmacological-EEG [Acute drug effects (60 minutes, 240 minutes)]

   Event-Related Potentials (ERP)

Secondary Outcome Measures

1. 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)

2. Change in biomarkers [Baseline, Acute drug effects (30 minutes, 90 minutes, 150 minutes, 300 minutes)]

   Brain-derived Neurotrophic Factor (BDNF)

3. 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)]

   Hypothalamic-Pituitary-Adrenal Axis (HPA-A)

4. 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)]

   API (DMT, Harmine)

5. Change in biomarkers [Baseline, Acute drug effects (30 minutes, 90 minutes, 150 minutes, 300 minutes)]

   Neuroinflammation - Interleukines

6. Change in biomarkers [Baseline, Acute drug effects (30 minutes, 90 minutes, 150 minutes, 300 minutes)]

   Oxidative Stress Markers (Nitric Oxide Synthase)

7. Psychometry [Baseline, Acute, 1 day after, 1 week after, 1 month after and 4 month after intervention]

   Cognitive Flexibility

8. Psychometry [Baseline, Acute, 1 day after, 1 week after, 1 month after and 4 month after intervention]

   MINDSENS

9. Psychometry [Baseline, Acute, 1 day after, 1 week after, 1 month after and 4 month after intervention]

   PANAS

10. Psychometry [Baseline, Acute, 1 day after, 1 week after, 1 month after and 4 month after intervention]

    CFI

11. Psychometry [Baseline, Acute, 1 day after, 1 week after, 1 month after and 4 month after intervention]

    SRQ

12. Psychometry [Baseline, Acute, 1 day after, 1 week after, 1 month after and 4 month after intervention]

    MBQ

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 40 Years
• Sexes Eligible for Study: Male
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Psychiatric University Hospital	Zürich		Switzerland	8032

Sponsors and Collaborators

• Psychiatric University Hospital, Zurich
• University of Basel

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Milan Scheidegger, Principal Investigator, Psychiatric University Hospital, Zurich
• ClinicalTrials.gov Identifier: NCT04716335
• Other Study ID Numbers: 2018-01385
• First Posted: Jan 20, 2021
• Last Update Posted: Nov 15, 2021
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Harmine

Study Results

No Results Posted as of Nov 15, 2021