Clinical TrialHealthy VolunteersDMTPlaceboPlaceboPlaceboCompleted

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

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.

Target Enrollment
34 participants
Study Type
Phase I interventional
Design
Randomized, quadruple Blind

Detailed Description

Randomised, quadruple-blind crossover study in healthy male volunteers (n=34) investigating effects of harmine and DMT on brain network dynamics, self-referential processing and prosocial behaviour.

Three-period crossover comparing harmine+DMT, harmine+placebo (DMT), and double placebo; outcomes focus on neurodynamics, emotion and social-cognitive measures. BMI 18.5–25; German language proficiency required.

Study Protocol

Preparation

sessions

Dosing

3 sessions

Integration

sessions

Study Arms & Interventions

Harmine + DMT

experimental

Harmine combined with DMT (active)

Interventions

  • DMT
    • single dose

    DMT (active) combined with harmine

  • Compound
    • single dose

    Harmine (beta-carboline) - active; formulation: drug listed as Harmine

Harmine + Placebo (DMT)

experimental

Harmine with placebo DMT

Interventions

  • Compound
    • single dose

    Harmine (beta-carboline) - active

  • Placebo
    • single dose

    Placebo for DMT

Placebo (Harmine & DMT)

inactive

Placebo for both harmine and DMT

Interventions

  • Placebo
    • single dose

    Placebo for Harmine

  • Placebo
    • single dose

    Placebo for DMT

Participants

Ages
20 – 40
Sexes
male

Inclusion Criteria

  • Inclusion Criteria:\n\n* Willing and capable to give informed consent for the participation in the study after it has been thoroughly explained\n* Little or no previous experiences with psychedelic substances\n* Body mass index (BMI) between 18.5 and 25\n* 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\n* Able and willing to comply with all study requirements\n* Informed consent form was signed\n* Good knowledge of the German language

Exclusion Criteria

  • Exclusion Criteria:\n\n* Previous significant adverse response to a hallucinogenic drug\n* Participation in another study where pharmaceutical compounds will be given\n* Self or first-degree relatives with present or antecedent psychiatric disorders\n* History of head trauma or fainting\n* Recent cardiac or brain surgery\n* Current use of medication or psychotropic substances (including nicotine addiction)\n* Presence of major internal or neurological disorders (including sepsis, pheochromocytoma, thyrotoxicosis, drug-induced fibrosis, familiar or basilar artery migraine)\n* Cardiovascular disease (hypertonia, coronary artery disease, heart insufficiency, myocardial infarction, coronary spastic angina)\n* Peripheral vascular disease (thromboangiitis obliterans, luetic arteritis, severe arteriosclerosis, thrombophlebitis, Raynaud's disease)\n* Liver or renal disease

Study Details

Locations

Psychiatric University Hospital — Zurich, Switzerland

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