5-MeO-DMT for Healthy Volunteers

5 papers and 6 clinical trials exploring 5-meo-dmt as a treatment for healthy volunteers.

CompoundTryptamine

5-MeO-DMT

A potent tryptamine psychedelic known for profound mystical experiences, currently under clinical investigation for TRD and anxiety.

Full 5-MeO-DMT profile
IndicationApproximately 300 million people affected by depression worldwide.

Healthy Volunteers

Research involving healthy volunteers has expanded to investigate the therapeutic potentials of various psychedelics for mental health conditions. Recent findings, emphasizing compounds like psilocybin and DMT, illustrate a promising future for psychedelic-assisted therapies.

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Academic Research

5 papers
Open Accessindividual

Evaluation of the peak experience scale as a rapid assessment tool for the strength of a psychoactive experience with 5-MeO-DMT

The three-item Peak Experience Scale (PES) reliably and rapidly measures the strength of 5‑MeO‑DMT experiences, showing dose-related increases, a single PCA component explaining 83.5% of variance, high internal consistency (α = 0.896) and strong correlations with established measures (MEQ-30, EDI, 5D-ASC) but not the CEQ. The authors conclude the PES could be used to gain fast insight into psychedelic intensity in individual patients and to guide dose and re-dose decisions for rapid-acting psychedelics.

Published
Journal
Frontiers in Psychology
Authors
Mason, N. L., Ramaekers, J. G., Reckweg, J., Svendsen, C. B., Terwey, T. H., Theunissen, E. L.
Paywallmeta

Adverse Events in Studies of Classic Psychedelics: A Systematic Review and Meta-Analysis

This systematic review and meta‑analysis of 214 studies (3,504 participants with analysable adverse‑event data) found that high‑dose classic psychedelics were generally well tolerated in clinical/research settings, with serious adverse events occurring mainly in ~4% of participants who had preexisting neuropsychiatric disorders and no reports in contemporary trials of suicide, persistent psychotic disorder or hallucinogen‑persisting perception disorder. Common non‑serious adverse events (headache, anxiety, nausea, fatigue, dizziness) had similar prevalences for psilocybin and LSD, but substantial heterogeneity and limited systematic adverse‑event monitoring across studies highlight the need for improved pharmacovigilance.

Published
Journal
JAMA Psychiatry
Authors
Graziosi, M., Hinkle, J. T., Nayak, S., Yaden, D. B.
Paywallindividual

Phase 1, placebo-controlled, single ascending dose trial to evaluate the safety, pharmacokinetics and effect on altered states of consciousness of intranasal BPL-003 (5-methoxy-N,N-dimethyltryptamine benzoate) in healthy participants

In this double-blind, placebo-controlled Phase 1 trial, intranasal BPL-003 (5‑MeO‑DMT benzoate) was well tolerated up to 12 mg and showed rapid absorption and elimination with dose‑proportional systemic exposure (Tmax ≈ 8–10 min; mean terminal half‑life <27 min) and negligible bufotenine formation. Pharmacodynamic effects scaled with plasma concentrations, producing profound, short‑lasting consciousness‑altering and mystical experiences—60% of participants had a complete mystical experience at 10–12 mg—supporting further clinical evaluation.

Published
Journal
Journal of Psychopharmacology
Authors
Dunbar, F., Ermakova, A. O., Roberts, C. A., Rucker, J., Seynaeve, M., Suttle, B., Wiegand, F., Yamamoto, T., Young, A. H.
Open Accessindividual

A phase 1, dose-ranging study to assess safety and psychoactive effects of a vaporized 5-methoxy-N,N-dimethyltryptamine formulation (GH001) in healthy volunteers

In a phase 1 dose-ranging study in 22 healthy volunteers, inhaled GH001 (5‑MeO‑DMT) was well tolerated and produced dose-related increases in psychedelic intensity, with individualized dose escalation yielding the largest mystical and ego‑dissolution effects (PES, MEQ, EDI, 5D‑ASC) while cognition, mood, well‑being, vitals and adverse events remained largely unaffected or mild. These findings indicate individualized dose escalation may be preferable to single fixed doses when aiming to maximise therapeutic psychedelic experiences.

Published
Journal
Frontiers in Pharmacology
Authors
Mason, N. L., Ramaekers, J. G., Reckweg, J., Terwey, T. H., Toennes, S. W., van Leeuwen, C.

Clinical Trials

6 trials

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