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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-22

Study Completion Date

2025-03-05

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effects of Dimethyltryptamine in Healthy Subjects

NCT04353024

Healthy

COMPLETED PHASE1

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

NCT04716335

Emotions Mood Cognitive Function 1, Social +1 more

COMPLETED EARLY_PHASE1

Functional Brain Imaging in Recreational Users of Ecstasy

NCT00254306

Amphetamine-Related Disorders

COMPLETED

Dose-finding Study for the Combination of DMT and Harmine in Healthy Subjects

NCT05829603

Healthy

COMPLETED PHASE1

Acute Dose-dependent Effects of DMT in Healthy Subjects

NCT05384678

Healthy

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Neuropharmacological Investigation of Ayahuasca Constituents DMT and Harmine

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Placebo first, intervention second

Participants allocated to this arm receive placebo on their first study day and the active drug under investigation on the second study day.

Group Type EXPERIMENTAL

N,N-dimethyltryptamine (DMT) + harmine

Intervention Type DRUG

DMT and harmine are the two most abundant chemicals in the Amazonian hallucinogenic plant brew, Ayahuasca, which is used traditionally in spiritual and healing ceremonies. An oral formulation of these two substances will be tested against placebo in the context of an FDG-PET scan.

Placebo

Intervention Type DRUG

Placebo will be administered on one of the study days to compare the effects of DMT and harmine with the effects a placebo administration.

Intervention first, placebo second

Participants allocated to this arm receive the active drug under investigation on their first study day and placebo on the second study day.

Group Type EXPERIMENTAL

N,N-dimethyltryptamine (DMT) + harmine

Intervention Type DRUG

DMT and harmine are the two most abundant chemicals in the Amazonian hallucinogenic plant brew, Ayahuasca, which is used traditionally in spiritual and healing ceremonies. An oral formulation of these two substances will be tested against placebo in the context of an FDG-PET scan.

Placebo

Intervention Type DRUG

Placebo will be administered on one of the study days to compare the effects of DMT and harmine with the effects a placebo administration.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

N,N-dimethyltryptamine (DMT) + harmine

DMT and harmine are the two most abundant chemicals in the Amazonian hallucinogenic plant brew, Ayahuasca, which is used traditionally in spiritual and healing ceremonies. An oral formulation of these two substances will be tested against placebo in the context of an FDG-PET scan.

Intervention Type DRUG

Placebo

Placebo will be administered on one of the study days to compare the effects of DMT and harmine with the effects a placebo administration.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).

Minimum Eligible Age

25 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes