CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 17 enrolled
Drug / intervention
N,N-dimethyltryptamine (DMT) + harmine +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06252506
NCT06252506Phase 1Completed

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

Insel Gruppe AG, University Hospital Bern·interventional·Posted Feb 9, 2024·Updated Mar 19, 2025

In Brief

A Phase 1 clinical trial evaluating N,N-dimethyltryptamine (DMT) + harmine and Placebo for Neuropharmacological Investigation of Ayahuasca Constituents DMT and Harmine. Completed, enrolled 17 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSwitzerland

Timeline

Phase 1CompletedFinished
202420252026
First PostedFeb 9, 2024
Enrollment StartJan 22, 2024
Primary CompletionFeb 17, 2025
Study CompletionMar 5, 2025
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 2.4 years ago

Interventions

N,N-dimethyltryptamine (DMT) + harminedrug

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.

Placebodrug

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