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

This Phase I interventional trial (n=16), known as HaD-PET, aims to investigate the acute cerebrometabolic effects of harmine/DMT (ayahuasca/pharmahuasca) in healthy volunteers using quantitative FDG-PET.

The study, sponsored by Insel Gruppe AG, University Hospital Bern, Switzerland, began on January 22, 2024. Participants must be between 25-45 years old, proficient in German, and willing to comply with study requirements. They should also have previous experience with psychedelics but not within the past three months. Exclusion criteria include significant adverse responses to psychedelic drugs, certain medical conditions, and recent participation in other pharmaceutical studies.

The study involves administering either DMT and harmine or a placebo to participants and measuring changes in cerebral metabolic rate for glucose (CMRglc) before and after treatment using PET scans.

Secondary outcome measures include assessing blood glucose levels, plasma concentrations of DMT, harmine, and their metabolites, as well as subjective effects, blood pressure, heart rate, and psychological questionnaires related to consciousness and emotional experiences.

The estimated study completion date is April 2025.

Topic Neuroscience Healthy Subjects
Compound Placebo Ayahuasca
Country Switzerland
Visit trial
Status Recruiting
Results Published No
Start date 22 January 2024
End date 30 April 2025
Phase Phase I
Design Blinded
Type Interventional
Generation First
Participants 16
Sex Male
Age 25- 45
Therapy No

Trial Details

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.

NCT Number NCT06252506

Data attribution

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