Molecular Imaging Study of Harmine/DMT: a Basic... — Clinical Trial Details

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.

Participants

Ages

25 – 45

Sexes

male

BMI

18.5 - 35

Psychosis History

Excluded

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)

Company

Product

Legal

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

Detailed Description

Study Protocol

Preparation

Dosing

Locations

Integration

Study Arms & Interventions

DMT + harmine

Interventions

Placebo

Interventions

Participants

Inclusion Criteria

Exclusion Criteria

Study Details

Study Team

Sponsors & Collaborators