AzTrials
AzTrials

EmotionsEarly Phase 1NCT04716335

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

A Early Phase 1 study testing DMT and Harmine in people with Emotions and Mood, run by Psychiatric University Hospital, Zurich at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 20 to 40 years, men onlyHealthy volunteers can take part
Conditions the study is for
Emotions, Mood, Cognitive Function 1, Social
What is being tested?
DMT and Harmine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
34 participants
Where
1 siteSwitzerland
Study dates
1 Dec 2020to 10 Jan 2022
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 40 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 10Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Psychiatric University Hospital

    Zurich, 8032

Other trials in Switzerland

About this study

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.

Being tested
DMT, Harmine, Placebo (Harmine), Placebo (DMT)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DMTDrug

    DMT

  • HarmineDrug

    Harmine

  • Placebo (Harmine)Drug

    Placebo for Harmine

  • Placebo (DMT)Drug

    Placebo for DMT

Study groups in NCT04716335
Study groupRoleWhat they receive
Harmine + DMTExperimentalNot described
Receives: Drug: DMT; Drug: Harmine
Harmine + Placebo(DMT)ExperimentalNot described
Receives: Drug: Harmine; Drug: Placebo (DMT)
Placebo(Harmin & Placebo)Placebo comparatorNot described
Receives: Drug: Placebo (Harmine); Drug: Placebo (DMT)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Social Cognition

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

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

    Self-referential Processing

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

  3. Change in Pharmacological-EEG (Lagged Phase Synchronicity)

    Functional brain connectivity

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

  4. Change in Pharmacological-EEG (Resting State)

    Spectral Density

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

  5. Change in Pharmacological-EEG

    Event-Related Potentials (ERP)

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

Secondary outcomes (12)

  1. Change in biomarkers

    Tryptophan catabolites (TRYCAT)

    Measured: 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)

  2. Change in biomarkers

    Brain-derived Neurotrophic Factor (BDNF)

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

  3. Change in biomarkers

    Hypothalamic-Pituitary-Adrenal Axis (HPA-A)

    Measured: 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)

  4. Change in biomarkers

    API (DMT, Harmine)

    Measured: 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)

  5. Change in biomarkers

    Neuroinflammation - Interleukines

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

  6. Change in biomarkers

    Oxidative Stress Markers (Nitric Oxide Synthase)

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

  7. Psychometry

    Cognitive Flexibility

    Measured: Baseline, Acute, 1 day after, 1 week after, 1 month after and 4 month after intervention

  8. Psychometry

    MINDSENS

    Measured: Baseline, Acute, 1 day after, 1 week after, 1 month after and 4 month after intervention

  9. Psychometry

    PANAS

    Measured: Baseline, Acute, 1 day after, 1 week after, 1 month after and 4 month after intervention

  10. Psychometry

    CFI

    Measured: Baseline, Acute, 1 day after, 1 week after, 1 month after and 4 month after intervention

  11. Psychometry

    SRQ

    Measured: Baseline, Acute, 1 day after, 1 week after, 1 month after and 4 month after intervention

  12. Psychometry

    MBQ

    Measured: Baseline, Acute, 1 day after, 1 week after, 1 month after and 4 month after intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jan 2021
  2. Study start1 Dec 2020
  3. Primary completion19 Jul 2021
  4. Study completion10 Jan 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04716335
Sponsor's protocol ID
2018-01385
Other IDs
2018
Status last verified
Oct 2022
First submitted
23 Dec 2020
Last updated
4 Oct 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Niedernhuber M, Suay D, Lenggenhager B, Muller M, Scheidegger M, Dornbierer D, Aicher H. N,N-Dimethyltryptamine and harmine formulation alters transient EEG topography sequences near the peak of the psychedelic state. J Psychopharmacol. 2026 Sep 22:2698811261481062. doi: 10.1177/02698811261481062. Online ahead of print.

    PubMed 42768932

  • Swieczkowski D, Kwasny A, Cubala WJ. Safety and tolerability of NN-dimethyltryptamine (DMT) in healthy volunteers and Major Depressive Disorder (MDD) patients: A systematic review of early-phase clinical trials. Prog Neuropsychopharmacol Biol Psychiatry. 2025 Jul 13;140:111419. doi: 10.1016/j.pnpbp.2025.111419. Epub 2025 Jun 7.

    PubMed 40484114

  • 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.

    PubMed 39774840

  • 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.

    PubMed 38089057

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing DMT and Harmine in people with Emotions and Mood, run by Psychiatric University Hospital, Zurich at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04716335, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in