CompletedEarly Phase 1

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

Switzerland34 participantsStarted 2020-12-01

Plain-language 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.

Who can participate

Age range

20 Years – 40 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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, Rayn…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Acute drug effects (240 minutes - Charity Donation Frank Task, 300 minutes - SVO)

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

Timeframe: Acute drug effects (60 min - Visuall Oddball, 150 min - Karaoke Task)

Change in Pharmacological-EEG (Lagged Phase Synchronicity)

Timeframe: Baseline, Acute drug effects (30 minutes , 135 minutes, 195 minutes, 285 minutes)

Change in Pharmacological-EEG (Resting State)

Timeframe: Baseline, Acute drug effects (30 minutes , 135 minutes, 195 minutes, 285 minutes)

Change in Pharmacological-EEG

Timeframe: Acute drug effects (60 minutes, 240 minutes)

Trial details

NCT IDNCT04716335

SponsorPsychiatric University Hospital, Zurich

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-07-19

View on ClinicalTrials.gov More Emotions trials

Who can participate

Age range

20 Years – 40 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Timeframe: Acute drug effects (240 minutes - Charity Donation Frank Task, 300 minutes - SVO)

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

Timeframe: Acute drug effects (60 min - Visuall Oddball, 150 min - Karaoke Task)

Change in Pharmacological-EEG (Lagged Phase Synchronicity)

Timeframe: Baseline, Acute drug effects (30 minutes , 135 minutes, 195 minutes, 285 minutes)

Change in Pharmacological-EEG (Resting State)

Timeframe: Baseline, Acute drug effects (30 minutes , 135 minutes, 195 minutes, 285 minutes)

Change in Pharmacological-EEG

Timeframe: Acute drug effects (60 minutes, 240 minutes)