NCT06252506

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Insel Gruppe AG, University Hospital Bern · Academic / Other
• Sex: Male
• Age: 25 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Neuropharmacological Investigation of Ayahuasca Constituents DMT and Harmine

Interventions

Type	Name	Description
DRUG	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.
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.

Timeline

• Start date: 2024-01-22
• Primary completion: 2025-02-17
• Completion: 2025-03-05
• First posted: 2024-02-09
• Last updated: 2025-03-19

Locations

2 sites across 1 country: Switzerland