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CompletedEarly Phase 1

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

NCT04716335 · Psychiatric University Hospital, Zurich

Closed to entry
Status
Not accepting participants
Early Phase 1
Phase
34
Target enrolment
1
Study sites
Outside the US

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Change in Behavioral Outcome Measures (Social Value Orientation - SVO, Charity Donation Frank Task)

    Measured over Acute drug effects (240 minutes - Charity Donation Frank Task, 300 minutes - SVO)

  • Change in Behavioral Outcome Measures (Visuall Oddball, Karaoke Task)

    Measured over Acute drug effects (60 min - Visuall Oddball, 150 min - Karaoke Task)

  • Change in Pharmacological-EEG (Lagged Phase Synchronicity)

    Measured over Baseline, Acute drug effects (30 minutes , 135 minutes, 195 minutes, 285 minutes)

  • Change in Pharmacological-EEG (Resting State)

    Measured over Baseline, Acute drug effects (30 minutes , 135 minutes, 195 minutes, 285 minutes)

  • Change in Pharmacological-EEG

    Measured over Acute drug effects (60 minutes, 240 minutes)

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

20 Years to 40 Years
Ages
MALE
Sex
Accepted
Healthy volunteers
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

Where

1 study site

FacilityCityRegionCountry
Psychiatric University HospitalZurichSwitzerland

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT04716335 on ClinicalTrials.gov →

Last updated in the registry 2022-10-04. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits