Molecular Imaging Study of Harmine/DMT: a Basic Research Approach

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Description

The few reports on effects of psychedelic substances on cerebral metabolic rate (CMRglc) indicate increases (psilocybin; human FDG-PET) or decreases (LSD, rat autoradiography; 5-MeO-DMT rat autoradiography). There are no reports of effects of DMT and/or harmine on cerebral energy metabolism. The primary objective of this study is thus to assess acute cerebrometabolic effects of harmine/DMT in healthy volunteers using quantitative FDG-PET, that is, to measure CMRglc before and after simultaneous treatment with an oral harmine and DMT formulation developed (and already applied) by the investigators' project partners at the University of Zurich. As a secondary objective, the researchers aim to correlate the time-dependent effects on CMRglc as assessed in the PET images with the time-dependent self-reported intensity of participants' psychedelic experience.

Study Overview

Start Date
January 22, 2024
Completion Date
April 1, 2025
Enrollment
16
Date Posted
February 9, 2024
Accepts Healthy Volunteers?
Yes
Gender
Male

Locations

Full Address
Psychiatric University Hospital Zurich
Zurich 8032, Switzerland

Eligibility

Minimum Age (years)
25
Maximum Age (years)
45
Eligibility Criteria
Inclusion Criteria:

Between 25-45 years old
Good command of the German language
Willing and capable to give consent for the participation in the study after it has been thoroughly explained
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, not otherwise specified), 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, familiar or basilar artery migraine)
Cardiovascular disease (hypertonia, coronary artery disease, heart insufficiency, myocardial infarction, coronary spastic angina) Version 5, 15/11/2023 16/44
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 or renal or pulmonary disease
Inability to lie still in the scanner for about 90 minutes (e.g., because of sneezing, itching, tremor, pain)
Left-handedness
Significant radiation exposure (either X-ray or nuclear medicine studies) in the last 12 months
Presence of claustrophobia or other contraindications to PET scanning
Presence of contraindications to MRI investigations: Magnetic parts in the body (piercings, brain aneurysm clip, implanted neural stimulator/cardiac pacemaker/defibrillator/Swan Ganz catheter/insulin pump, cochlear implant); metal shrapnel or bullet, ocular foreign body (e.g., metal shavings); current or previous job in metalworking industry
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 behavioral reaction based on investigator's clinical evaluation (e.g., evidence of serious personality disorder, serious current stressors, lack of social support).

Study Contact Info

Study Contact Name
Paul K Cumming, PhD; Klemens Egger, MSc
Study Contact Phone

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Other Details

FDA Regulated Drug?
No
FDA Regulated Device?
No
NCTid (if applicable)
NCT06252506