A review of 26 registered clinical trials of ayahuasca and DMT

The question

What does the landscape of registered clinical trials of ayahuasca and DMT look like, and what kinds of questions are these trials designed to answer?

What they did

The researchers searched ClinicalTrials.gov, a public registry where researchers list planned and ongoing trials, for interventional studies of DMT, ayahuasca, or DMT combined with harmine. They identified 26 eligible trial registrations. They pulled out details on trial phase, sponsor, who was eligible to take part, how the drug was given, and what outcomes were being measured, then linked completed trials to any published papers.

What they found

The number of registered trials grew after 2020-2021. Most were phase I, the earliest stage of human testing, which focuses on safety rather than effectiveness, and more than half were listed as completed. Most tested DMT on its own and were sponsored by universities or hospitals. Entry criteria were cautious, favouring physically and mentally healthy adults and excluding people with heart or psychiatric conditions, and the main outcomes measured were short-term safety, physical monitoring and the subjective experience, rather than symptom improvement in a specific disorder. A smaller group of depression-focused trials reported early signs of possible clinical benefit.

The fine print

This review maps what trials were registered, not whether the treatments work; it reports no pooled effectiveness or safety results. It relied on one registry, ClinicalTrials.gov, so trials registered elsewhere may have been missed, and registry entries can be incomplete or out of date. Most included trials enrolled healthy volunteers screened to exclude medical and psychiatric problems, so findings may not carry over to patients. This summary is based on the abstract alone.

What it means

Research on DMT and ayahuasca in humans is growing but still mostly at the earliest safety stage, with few trials yet testing whether these substances help specific conditions beyond depression.

Evidence grade: Low. This is a scoping review of trial registry entries rather than a pooled analysis of results, so it describes how research is being done rather than how well these substances work.

This summary is based on the study’s published abstract.