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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
34

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Switzerland
      • Zürich, Switzerland, 8032
        • Psychiatric University Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 (DMT)
Placebo for DMT
Drug: Placebo (Harmine)
Placebo for Harmine

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Psychiatric University Hospital, Zurich

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Basel

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 19, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 10, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 23, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 15, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 20, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 4, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 3, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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