Neuropharmacological Investigation of Ayahuasca Constituents DMT and Harmine
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Profil des participants
Sexe(s) des participants
Male
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Critères de sélection
Critères d'inclusion
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).
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Cohortes
Thérapie ou Intervention proposée
Cohortes
Nom
Condition médicale
Traitement
État du recrutement
Placebo first, intervention second
Donnée non disponible
Participants allocated to this arm receive placebo on their first study day and the active drug under investigation on the second study day.
Inconnu
Intervention first, placebo second
Donnée non disponible
Participants allocated to this arm receive the active drug under investigation on their first study day and placebo on the second study day.
Inconnu
Placebo first, intervention second
État du recrutement
unknown
Participants allocated to this arm receive placebo on their first study day and the active drug under investigation on the second study day.
Intervention first, placebo second
État du recrutement
unknown
Participants allocated to this arm receive the active drug under investigation on their first study day and placebo on the second study day.
Données à jour depuis :
11 février 2024
Description de l'étude
Description de l'étude
Résumé de l'étude
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.
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Centres participants
Sites
Centres participants
2
centres
DEPARTMENT OF NUCLEAR MEDICINE, BERN UNIVERSITY HOSPITAL
