Clinical TrialHealthy VolunteersAyahuascaPlaceboCompleted

Molecular Imaging Study of Harmine/DMT: a Basic Research Approach (HaD-PET)

Phase I, randomised, single-blind crossover FDG-PET study (n≈17) assessing acute cerebrometabolic effects of an oral harmine+DMT formulation versus placebo in healthy male volunteers.

Target Enrollment
17 participants
Study Type
Phase I interventional
Design
Randomized, single Blind

Detailed Description

This study assesses acute changes in cerebral metabolic rate for glucose (CMRglc) measured with quantitative FDG-PET before and after administration of an oral harmine+DMT formulation compared with placebo in healthy male volunteers.

Randomised crossover design with two single-dose study days per participant; secondary analyses will correlate time-dependent PET measures with self-reported intensity of the psychedelic experience.

Study Protocol

Preparation

sessions

Dosing

2 sessions
90 min each

Integration

sessions

Study Arms & Interventions

DMT + harmine

experimental

Oral DMT + harmine formulation; single-dose crossover session.

Interventions

  • Ayahuasca
    via Oral• single dose• 1 doses total

    Oral harmine+DMT formulation developed by University of Zurich; dose not specified in registry fragment.

Placebo

inactive

Matched placebo given in crossover.

Interventions

  • Placebo
    via Oral• single dose• 1 doses total

    Placebo administered on one of the two study days.

Participants

Ages
25 – 45
Sexes
male

Inclusion Criteria

  • Between 25-45 years old
  • Good command of the German language
  • Willing and capable to give consent after full explanation
  • Willing and capable to comply with all study requirements
  • Body mass index (BMI) between 18.5 and 35
  • Previous experience with psychedelics, but not in the past three months
  • Willing to abstain from alcohol, caffeinated drinks, nicotine, food, and sugary drinks for two hours prior to the PET scan on the testing day, and from consuming psychoactive substances for 2 weeks before the first testing day and for the duration of the study

Exclusion Criteria

  • Previous significant adverse response to a psychedelic drug
  • Recent or concurrent participation in another study where pharmaceutical compounds will be given
  • Presence of Axis I affective, anxiety, or dissociative disorders
  • Present or antecedent diagnosis of bipolar disorder (I, II, NOS), schizophrenia, schizoaffective disorder, psychosis, or other disorders from the psychotic spectrum
  • First-degree relatives with present or antecedent schizophrenia, schizoaffective disorder, or bipolar disorder type I
  • History of head trauma, seizures, cancer, or cerebrovascular accidents
  • Recent cardiac or brain surgery
  • Current abuse of medication or psychotropic substances according to SCID I criteria
  • Presence of major internal or neurological disorders (including sepsis, pheochromocytoma, thyrotoxicosis, drug-induced fibrosis, familial 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)
  • Cerebrovascular disease (e.g., stroke, intracranial bleeding/hemorrhage, intracranial aneurysm)
  • Diabetes Type 1/2, Metabolic Syndrome
  • Serious abnormalities in ECG or blood count/chemistry
  • Liver, renal, or pulmonary disease
  • Inability to lie still in the scanner for about 90 minutes (e.g., due to sneezing, itching, tremor, pain)
  • Left-handedness
  • Significant radiation exposure (X-ray or nuclear medicine) in the last 12 months
  • Presence of claustrophobia or other contraindications to PET scanning
  • Contraindications to MRI (magnetic parts in body, metal shrapnel, implants, cochlear implant, etc.)
  • Current use of medications with significant interaction potential with MAO inhibitors (e.g., antidepressants, antipsychotics, psychostimulants, dopaminergic/serotonergic agents, anticonvulsants)
  • High risk of adverse emotional or behavioural reaction based on investigator's clinical evaluation (e.g., evidence of serious personality disorder, serious current stressors, lack of social support)

Study Details

  • Status
    Completed
  • Phase
    Phase I
  • Type
    interventional
  • Design
    Randomizedsingle Blind
  • Target Enrollment17 participants
  • Timeline
    Start: 2024-01-22
    End: 2025-04-30
  • Compounds
    AyahuascaPlacebo
  • Topic
    Healthy Volunteers

Locations

Department of Nuclear Medicine, Bern University Hospital — Bern, Switzerland
Psychiatric University Hospital Zurich — Zurich, Switzerland

Your Library