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

Psychiatric University Hospital, Zurich

Status and phase: Completed; Early Phase 1

Conditions: Empathy; Emotions; Mood; Cognitive Function 1, Social

Treatments: Drug: DMT; Drug: Placebo (Harmine); Drug: Harmine; Drug: Placebo (DMT)

Study type: Interventional

Funder types: Other

Identifiers

NCT04716335

2018-01385

Details and patient eligibility

About

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.

Enrollment: 34 patients

Sex: Male

Ages: 20 to 40 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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34 participants in 3 patient groups, including a placebo group

Harmine + DMT

Experimental group

Treatment:

Drug: Harmine

Drug: DMT

Harmine + Placebo(DMT)

Experimental group

Treatment:

Drug: Harmine

Drug: Placebo (DMT)

Placebo(Harmin & Placebo)

Placebo Comparator group

Treatment:

Drug: Placebo (DMT)

Drug: Placebo (Harmine)