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Home/Research/5-MeO-DMT/Safety & Risk Management

5-MeO-DMT for Safety & Risk Management

10 papers and 2 clinical trials exploring 5-meo-dmt as a treatment for safety & risk management.

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
IndicationMental health disorders affect over 900 million people worldwide, with conditions like PTSD and depression being among the most prevalent.

Safety & Risk Management

Safety and risk management in psychedelic therapy remains a critical area of research, necessitating vigilant assessment of potential adverse effects as clinical usage expands. Current efforts focus on ensuring that therapeutic practices minimise harm while maximising efficacy for a range of conditions.

Full Safety & Risk Management profile

Academic Research

10 papers
Paywallindividual

A phase 2 uncontrolled, open-label study of intranasal BPL-003 (5-methoxy-N,N-dimethyltryptamine) in patients with treatment-resistant depression

This 12‑week, open‑label Phase IIa trial of a single 10 mg intranasal dose of 5‑MeO-DMT (BPL‑003) in patients (n=12) with treatment‑resistant major depressive disorder, found that the drug was generally well tolerated with mostly mild–moderate adverse events and rapid discharge readiness (median ~98 minutes). A rapid and sustained mean MADRS reduction of 12–13 points was observed from Day 2 through Day 85, with most participants meeting response criteria and several achieving remission, supporting further evaluation in larger controlled trials.

Published
February 27, 2026
Journal
Journal of Psychopharmacology
Authors
Roberts, C., Seynaeve, M., Ermakova, A. O., Dunbar, F., Wells, H., Puri, A., Bird, C., Rucker, J. J.
Open Accessindividual

Efficacy and Safety of the Neuroplastogen TSND-201 for the Treatment of PTSD A Randomized Clinical Trial

In a multicentre, double‑blind, placebo‑controlled phase 2 trial of 65 adults with chronic PTSD, once‑weekly oral TSND‑201 produced significantly greater reductions in clinician‑rated PTSD severity (CAPS‑5; LS mean difference 9.64, P = .01) and improvements in self‑reported symptoms, functioning and depression versus placebo. TSND‑201 was generally well tolerated — common adverse events included headache, decreased appetite, nausea, dizziness and transient blood‑pressure increases — supporting its potential as a rapid‑acting, durable treatment for PTSD.

Published
February 18, 2026
Journal
JAMA Psychiatry
Authors
Jones, A., Warner-Schmidt, J., Kwak, H., Stogniew, M., Mandell, B., Ching, T. H., Stein, M. B., Kelmendi, B.
Open Accessindividual

5-Methoxy-N,N-dimethyltryptamine (5-MeO-DMT) for alcohol use disorder: An open-label, phase 2, proof-of-concept, clinical trial

In an open‑label Phase IIa trial (n-12), a single 10 mg intranasal dose of 5‑MeO‑DMT (BPL‑003) given alongside a 10‑week relapse‑prevention CBT programme was acceptable in safety and tolerability in people with moderate–severe alcohol use disorder. Over 12 weeks, participants showed large improvements in drinking (mean abstinent days rose from 33.2% to 80.8% and heavy drinking days fell from 56.2% to 13.2%), providing preliminary evidence of efficacy and supporting larger controlled trials.

Published
December 10, 2025
Journal
Addiction
Authors
Marsden, J., Kelleher, M., Dunbar, F., Ermakova, A. O., Mitcheson, L., Roberts, C., Rucker, J. J., Scott, G., Saeger, I., Small, F., Seynaeve, M.
Paywallindividual

Safety and tolerability of multiple sublingual microdoses of 5-MeO-DMT in adults with moderate symptoms of depression and/or anxiety: a randomized, double-blind, placebo-controlled study

This Phase I clinical trial (n=36) of sublingual 5-MeO-DMT (6-12 mg weekly doses over four weeks) in adults with moderate to high anxiety/depression demonstrated good safety and tolerability with no significant adverse events, rapid absorption with peak plasma concentrations at 20 minutes, dose-dependent neurophysiological modulation without full psychedelic effects, and maintenance of normal cognitive and behavioral function.

Published
July 15, 2025
Journal
Neuropsychopharmacology
Authors
Beatriz, M., Millón, B., Noguera, L., Bruno, D., Vita, L., Zanino, M., Kassuha, D. E., Ortiz, J. E., Feresin, G. E., Díaz-Dellavalle, P., Orosco, L., Garcés, M. A., Diez, P., Albarracín, S. G., Bruno, M. A.
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
December 1, 2024
Journal
JAMA Psychiatry
Authors
Hinkle, J. T., Graziosi, M., 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
April 14, 2024
Journal
Journal of Psychopharmacology
Authors
Rucker, J., Roberts, C. A., Seynaeve, M., Young, A. H., Suttle, B., Yamamoto, T., Ermakova, A. O., Dunbar, F., Wiegand, F.

Clinical Trials

2 trials
CompletedPhase I

Pharmacokinetics, Safety, and Tolerability of Intramuscular 5-MeO-DMT in Healthy Volunteers

This double-blind, placebo-controlled trial (n=54) will administer 5-MeO-DMT intramuscularly in varying doses (single 0.5–13 mg and multiple-dose combinations) in healthy adults to assess pharmacokinetics, safety, and tolerability.

Started
December 27, 2022
Type
interventional
Blinding
triple
Randomized
Yes
Registry ID
NCT05698095
CompletedPhase I

Pharmacokinetics of GH001 in Healthy Volunteers

Randomized, double-blind, placebo-controlled single-dose and open-label multiple-dose Phase I study in healthy volunteers (n=46) assessing inhaled GH001 (5‑MeO‑DMT) at 6, 12 and 18 mg for pharmacokinetics, safety and psychoactive effects.

Started
June 21, 2021
Type
interventional
Blinding
triple
Randomized
Yes
Registry ID
NCT05163691

Explore further

Search all 5-MeO-DMT papers Search all Safety & Risk Management trials Full 5-MeO-DMT profile Full Safety & Risk Management profile