Neurodynamics of Prosocial Emotional Processing Following Serotonergic Stimulation With N,N-Dimethyltryptamine (DMT) and Harmine in Healthy Subjects
NCT ID: NCT04716335
Last Updated: 2022-10-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
EARLY_PHASE1
34 participants
INTERVENTIONAL
2020-12-01
2022-01-10
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Does Serotonin System Stimulation Increase Pro-social Behavior? - A Comparative Pharmacological Neuroscientific Study in Healthy Humans
NCT06081179
Antidepressant Response of DMT Masked With Propofol
NCT06927076
Effects of Dimethyltryptamine in Healthy Subjects
NCT04353024
Molecular Imaging Study of Harmine/DMT: a Basic Research Approach
NCT06252506
Effects of Drugs on Responses to Brain and Emotional Processes
NCT04053036
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
BASIC_SCIENCE
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Harmine + DMT
DMT
DMT
Harmine
Harmine
Harmine + Placebo(DMT)
Harmine
Harmine
Placebo (DMT)
Placebo for DMT
Placebo(Harmin & Placebo)
Placebo (Harmine)
Placebo for Harmine
Placebo (DMT)
Placebo for DMT
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
DMT
DMT
Harmine
Harmine
Placebo (Harmine)
Placebo for Harmine
Placebo (DMT)
Placebo for DMT
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
20 Years
40 Years
MALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Basel
OTHER
Psychiatric University Hospital, Zurich
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Milan Scheidegger
Principal Investigator
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Psychiatric University Hospital
Zurich, , Switzerland
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2018-01385
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.