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

NCT04716335 | Completed Early Phase 1

• 1 other identifier: 2018-01385
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Emotions; Mood; Cognitive Function 1, Social; Empathy

Outcome Measures

Primary Outcomes (5)

• 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)

Secondary Outcomes (12)

• 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)

• Change in biomarkers

  Baseline, Acute drug effects (30 minutes, 90 minutes, 150 minutes, 300 minutes)

• 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)

• 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)

• Change in biomarkers

  Baseline, Acute drug effects (30 minutes, 90 minutes, 150 minutes, 300 minutes)

Study Arms (3)

Harmine + DMT

EXPERIMENTAL

Drug: DMT; Drug: Harmine

Harmine + Placebo(DMT)

EXPERIMENTAL

Drug: Harmine; Drug: Placebo (DMT)

Placebo(Harmin & Placebo)

PLACEBO COMPARATOR

Drug: Placebo (Harmine); Drug: Placebo (DMT)

Interventions

DMT DRUG

DMT

Harmine + DMT

Harmine DRUG

Harmine

Harmine + DMT; Harmine + Placebo(DMT)

Placebo (Harmine) DRUG

Placebo for Harmine

Placebo(Harmin & Placebo)

Placebo (DMT) DRUG

Placebo for DMT

Harmine + Placebo(DMT); Placebo(Harmin & Placebo)

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Psychiatric University Hospital, Zurich: lead
• University of Basel: collaborator

Study Sites (1)

Psychiatric University Hospital

Zurich, 8032, Switzerland

Location

Related Publications (2)

• 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.

  PMID: 39774840 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.

  PMID: 38089057 DERIVED

MeSH Terms

Interventions

Harmine; N,N-Dimethyltryptamine

Intervention Hierarchy (Ancestors)

Harmala Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Carbolines; Heterocyclic Compounds, 3-Ring; Tryptamines; Biogenic Monoamines; Biogenic Amines; Amines; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 23, 2020
• First Posted: January 20, 2021
• Study Start: December 1, 2020
• Primary Completion: July 19, 2021
• Study Completion: January 10, 2022
• Last Updated: October 4, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)