Papers

Research literature with structured metadata.

Trials

Registered studies by status, phase, and compound.

Topics

Indications and themes psychedelics are researched for.

Compounds

Evidence across molecules with rich data.

Countries

Regulation, access, and research activity by region.

Stakeholders

Organizations shaping the space across research, policy, and funding.

People

Investigators, clinicians, and authors with mapped output.

Courses

Training programs and certifications across modalities.

Events

Conferences, workshops, and convenings by date and focus.

Results

Compare outcome data across trials and publications.

Research Snapshot

One-page overview of trials, participants, papers, and research networks.

Clinical Guidelines

Trial-anchored manuals and protocol guidance with competency mapping.

Research recaps

Monthly evidence summaries with key takeaways.

Map of research

Landscape view of trials, compounds, and outcomes.

Newsletter

Weekly or daily updates on trials, publications, analysis, and more.

Research Groups

Worldwide map of psychedelic research centres by region.

Road to Access

Science, regulation, and economics on the path to patient access.

Research Network

Interactive co-authorship map of psychedelic researchers.

Top papers

Find needles in the haystack of psychedelic research per topic.

AskBeta
Pricing

The intelligence layer for psychedelic research.

Company

  • About
  • Contact
  • Newsletter

Product

  • Feedback
  • Roadmap
  • Changelog
  • API
  • Partners
  • Clinical Guidelines

Legal

  • Privacy
  • Terms

© 2026 Blossom. All rights reserved.

Home/Research/DMT/Safety & Risk Management

DMT for Safety & Risk Management

20 papers and 4 clinical trials exploring dmt as a treatment for safety & risk management.

CompoundTryptamine

DMT

A powerful, short-acting tryptamine psychedelic found in many botanical sources, known for rapid onset and intense subjective experiences.

Full 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

20 papers
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

Naturalistic psychedelic use and changes in depressive symptoms

This longitudinal observational study (n=12,345) of U.S. residents found that naturalistic psychedelic use (n=505, 4.1% of participants) was associated with modest increases in depressive symptoms, particularly when occurring in 'risk contexts' characterised by negative mindset and lack of psychological support, with challenging psychedelic experiences mediating this relationship and suggesting that unsupervised psychedelic use may not be generally therapeutic and could worsen depression under certain circumstances.

Published
December 1, 2025
Journal
Journal of Affective Disorders
Authors
Simonsson, O., Hendricks, P. S., Swords, C. M., Osika, W., Goldberg, S. B.
Open Accessindividual

A novel psychedelic 5-HT2A receptor agonist GM-2505: The pharmacokinetic, safety, and pharmacodynamic profile from a randomized trial healthy volunteer

In a randomized, placebo‑controlled ascending‑dose study in 48 healthy volunteers, single IV doses of GM‑2505 up to 20 mg were well tolerated and showed dose‑proportional pharmacokinetics (t1/2 40–50 min) with dose‑dependent neuroendocrine, neurophysiological and subjective psychedelic effects, including decreased theta/alpha and increased gamma EEG power. The duration of cardiovascular and subjective effects was intermediate between psilocybin and DMT, indicating a practical 10–15 mg IV dose range for supervised clinical use.

Published
October 16, 2025
Journal
Journal of Psychopharmacology
Authors
Marek, G. J., Makai-Bölöni, S., Umbricht, D., Christian, E. P., Winters, J., Dvorak, D., Raines, S., Hughes, Z. A., Austin, E. W., Klein, A. K., Leong, W., Krol, F. J., Van Der Graaf, A. J., Juachon, M. J., Otto, M. E., Borghans, L. G. J. M., Jacobs, G., Kruegel, A. C., Sporn, J.
Paywallindividual

Zalsupindole is a Nondissociative, Nonhallucinogenic Neuroplastogen with Therapeutic Effects Comparable to Ketamine and Psychedelics

This rat study found that zalsupindole (third-generation psychedelic) produced robust effects on structural and functional neuroplasticity in the prefrontal cortex as well as sustained antidepressant-like responses comparable to or greater than those of ketamine, psilocybin, and DMT, despite lacking any of the acute cellular and behavioural characteristics of hallucinogenic or dissociative compounds.

Published
October 13, 2025
Journal
ACS Chemical Neuroscience
Authors
Agrawal, R., Gillie, D., Mungenast, A., Chytil, M., Engel, S., Wu, M. C., Rasmussen, K., Salinas, E., Olson, D. E.
Open Accessindividual

DMT and harmala alkaloids: an exploratory study of oral Acacia based formulations in healthy volunteers

In this open-label exploratory crossover study of nine experienced ayahuasca users, three Acacia‑derived oral formulations delivering DMT plus harmala alkaloids were well tolerated, produced no clinically significant physiological changes, and elicited psychedelic effects rated comparable to (and for ACL‑010 sometimes more beneficial than) traditional ayahuasca. These findings suggest Acacia‑based DMT/harmala formulations are a feasible alternative for future clinical trials, although generalisability is limited by the small sample size and open‑label design.

Published
August 15, 2025
Journal
Frontiers in Psychiatry
Authors
Bonomo, Y. A., Norman, A. F., Collins, L., Ross, M., Dwyer, J., Perkins, D., Sarris, J.
Paywallindividual

Safety, tolerability and subjective effects of vaporized N,N-Dimethyltryptamine: A randomized double-blind clinical trial

This first RCT (n=25) of vaporised DMT (60mg) demonstrated that DMT significantly increased subjective experience measures while causing only transient, safe physiological changes and predominantly mild adverse events. This suggests that inhaled DMT is safe, well-tolerated, and effective at inducing profound altered states of consciousness. Significant correlations were observed between physiological responses and subjective experiences.

Published
June 17, 2025
Journal
European Neuropsychopharmacology
Authors
Wießner, I., Falchi-Carvalho, M., Laborde, S., Barros, H., Bolcont, R., Ruschi Silva, S., Pantrigo, E. J., Medina, M., Arichelle, F., Almeida, R., Aires, R., Nunes Ferreira, L. F., Dantas Correa, L., da Costa Bezerra, R. B., Thie, K., Silva-Costa, N., Araújo, D. B., de Araujo Costa Neto, L. A., Lima de Queiroz, M. V. J., Galvão-Coelho, N. L., Palhano-Fontes, F.

Clinical Trials

4 trials
CompletedPhase I

Dose-finding Study for the Combination of DMT and Harmine in Healthy Subjects (DHTP)

Randomised Phase I study (n=16) comparing PK/PD and safety of six varying doses of a fixed-combination of DMT and harmine across six study days in healthy volunteers with continuous psychological support.

Started
May 1, 2023
Type
interventional
Blinding
single
Randomized
Yes
Registry ID
NCT05829603
CompletedPhase I

Safety and Tolerability of DMT in Healthy Adults

Phase I, double-blind, randomised, placebo-controlled crossover in healthy volunteers (n=25) comparing inhaled DMT 60 mg with a 1 mg placebo-like inhalation across two sessions on the same day.

Started
April 26, 2023
Type
interventional
Blinding
double
Randomized
Yes
Registry ID
NCT05901012
CompletedPhase I

Safety, tolerability, pharmacokinetics, pharmacodynamics and exploratory efficacy of intravenous dosing of SPL026 drug product (N, N-dimethyltryptamine fumarate; DMT Fumarate [A Serotonergic Psychedelic]) alone or in combination with selective serotonin reuptake inhibitors in patients with major depressive disorder

Open-label Phase I study (n=24 planned; 18 enrolled) single 27.5 mg IV SPL026 (DMT fumarate) 10-minute infusion in adults with major depressive disorder, comparing patients on stable SSRI versus those not on pharmacotherapy; primary outcomes: safety, PK/PD and exploratory efficacy.

Started
December 13, 2022
Type
interventional
Blinding
none
Randomized
No
Registry ID
ISRCTN10974027
CompletedPhase I

Safety, blood levels and effects of N,N-dimethyltryptamine [DMT (SPL026)] in healthy participants that have taken psychedelic substances before (Part A) and in healthy participants with little to no psychedelic experience (Part B)

Open-label, crossover Phase I study (target n=30, actual enrolment 14) assessing safety, blood levels and effects of SPL026 (DMT fumarate) given IM and IV in healthy psychedelic-experienced (Part A) and little/no-experience (Part B) participants.

Started
May 22, 2022
Type
interventional
Blinding
none
Randomized
No
Registry ID
ISRCTN63723571

Explore further

Search all DMT papers Search all Safety & Risk Management trials Full DMT profile Full Safety & Risk Management profile