Trial reportJournal of psychopharmacology (Oxford, England)2026
Investigating the safety and tolerability of single-dose psilocybin for post-traumatic stress disorder: A nonrandomized open-label clinical trial.
Trial report in Journal of psychopharmacology (Oxford, England), 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05312151 (The Safety and Tolerability of COMP360 in Participants With Post-traumatic Stress Disorder), which is not on this map. Cited by 8 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
The Safety and Tolerability of COMP360 in Participants With Post-traumatic Stress Disorder
Who cites it
8 citing papers in PubMed.
- Acute dose-dependent effects of 4-bromo-2,5-dimethoxyphenethylamine (2C-B) compared with 3,4-methylenedioxymethamphetamine (MDMA) and psilocybin in a double-blind, placebo-controlled study in healthy participants.Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology · 2026Trial
- Medical and Psychiatric Consultation for Patients Considering State-Regulated Psilocybin Services: A Risk-Reduction Model and Two Illustrative Cases.Research square · 2026Article
- Psilocybin-Assisted Therapy in Psychiatry: A Narrative Clinical Review of Mechanisms, Therapeutic Applications, and Emerging Evidence (2025-2026).Journal of clinical medicine · 2026Review
- Safety, feasibility, and preliminary clinical outcomes of psilocybin-assisted therapy for veterans with severe, treatment-resistant PTSD: an open-label pilot clinical trial.Communications medicine · 2026Article
- The Emerging Neurobiology of Psychedelics: Critical Periods, Metaplasticity, and Extracellular Matrix Remodeling.Annual review of neuroscience · 2026Review
- Trials, trips, and tribulations: pathways for implementing psychedelic therapy in Ireland.The international journal of neuropsychopharmacology · 2026Review
- Community engagement as a foundation for implementation research for group psilocybin assisted therapy in New Mexico.Frontiers in public health · 2026Article
- Investigational psilocybin treatment for post-traumatic stress disorder: a qualitative study of participant experience, trauma engagement, and differences from standard treatment.EClinicalMedicine · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundPost-traumatic stress disorder (PTSD) is a debilitating condition for which there are few efficacious treatments. Psilocybin is being studied for use in treatment-resistant depression but has not yet been investigated in PTSD.
aimsThe trial's primary outcome was to investigate the safety and tolerability of single-dose psilocybin in participants with PTSD.
methodsThis was a Phase 2, nonrandomized, open-label, multicenter trial. Secondary outcomes were changes in PTSD symptoms (Clinician-Administered PTSD Scale for DSM-5 (CAPS-5); PTSD Checklist for DSM-5 (PCL-5)), functional impairment (Sheehan Disability Scale; SDS) and quality of life (EQ-5D-5L index score).
resultsAmongst the 22 participants enrolled (63.6% female; mean (SD) age, 39.0 (7.91) years), there was a total of 117 treatment-emergent adverse events (TEAEs); 70 (59.8%) were reported on administration day, of which 64/70 (91.4%) resolved by the end of the next day. TEAEs commonly included headache (
conclusionsPsilocybin at a dose of 25 mg, administered with psychological support, may be safe, well-tolerated and associated with symptomatic improvement in adults with PTSD. Further investigation is warranted. CLINICAL
trial registrationClinicalTrials.gov Identifier: NCT05312151(https://clinicaltrials.gov/study/NCT05312151).
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.