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Home/Research/Ayahuasca/Safety & Risk Management

Ayahuasca for Safety & Risk Management

27 papers and 0 clinical trials exploring ayahuasca as a treatment for safety & risk management.

Compoundclassic psychedelic

Ayahuasca

Ayahuasca is a botanical decoction combining DMT with MAO-inhibiting harmala alkaloids, producing intense psychedelic effects lasting 3-6 hours. Clinical trials show rapid, large antidepressant effects from a single dose, with a favourable safety profile in controlled settings.

Full Ayahuasca 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

27 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

Ayahuasca-assisted meaning reconstruction therapy as an early resource for bereavement: a non-randomized clinical trial

In this non-randomised, three-arm clinical trial of 84 adults bereaved within 12 months, ayahuasca-assisted meaning reconstruction therapy (A-MR) was well tolerated and produced significantly larger reductions in grief severity and greater improvements in prolonged grief symptoms, post‑traumatic growth and quality of life than meaning reconstruction alone or no treatment. These preliminary findings support A-MR as a potentially effective early intervention for severe grief but require replication in larger randomised trials.

Published
September 1, 2025
Journal
Scientific Reports
Authors
Soto-Angona, Ó., Andión, O., Sabucedo, P., Neimeyer, R. A., Haro, J. M., Javkin, J., Farré, M., González, D.
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

Rapid and sustained antidepressant effects of vaporized N,N-dimethyltryptamine: a phase 2a clinical trial in treatment-resistant depression

This open-label fixed-order dose-escalation trial (n=14) evaluated inhaled DMT (15mg & 60mg) for treatment-resistant depression (TRD) for the first time. Results showed rapid and sustained antidepressant effects with a 21-point reduction on the Montgomery-Asberg Depression Rating Scale by day 7 (p<0.001), an 86% response rate, and a 57% remission rate lasting up to 3 months, with significant decreases in suicidal ideation (SI).

Published
April 22, 2025
Journal
Neuropsychopharmacology
Authors
Falchi-Carvalho, M., Palhano-Fontes, F., Wießner, I., Barros, H., Bolcont, R., Laborde, S., Silva, S. R. B., Montanini, D., Barbosa, D. C., Teixeira, E., Florence-Vilela, R., Almeida, R., Macedo, R. K. A., Arichelle, F., Pantrigo, E. J., Costa-Macedo, J. V., da Cruz Nunes, J. A., Araújo, D. B., de Araujo Costa Neto, L. A., Nunes Ferreira, L. F., Dantas Correa, L., da Costa Bezerra, R. B., Arcoverde, E., Galvão-Coelho, N. L.
Open Accessindividual

Pharmacokinetics and Pharmacodynamics of an Innovative Psychedelic N,N-Dimethyltryptamine/Harmine Formulation in Healthy Participants: A Randomized Controlled Trial

This secondary analysis of an RCT (n=31) evaluates a novel pharmaceutical formulation of DMT and harmine in healthy male volunteers. The study finds that intranasal DMT and buccal harmine (pharmahuasca) produce consistent pharmacokinetic profiles and safe, well-tolerated effects resembling ayahuasca, with subjective experiences lasting 2-3 hours. This formulation is proposed as a safer, standardised alternative for potential therapeutic use in mental health disorders.

Published
January 8, 2025
Journal
International Journal of Neuropsychopharmacology
Authors
Mueller, J., Mueller, M. J., Aicher, H. D., Dornbierer, D. A., Marten, L., Suay, D., Meling, D., Elsner, C., Wicki, I., Poetzsch, S. N., Caflisch, L., Hempe, A., Steinhart, C., Puchkov, M., Kost, J., Landolt, H-P., Seifritz, E., Quednow, B. B., Scheidegger, M.

Clinical Trials

0 trials

No clinical trials have been tagged with both Ayahuasca and Safety & Risk Management yet.

Trials are continuously being added as new studies are registered.

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