The New England journal of medicine
November 3, 2022
Guy M Goodwin, Scott T Aaronson, Oscar Alvarez et al.
1,095 citations
A single 25 mg dose of psilocybin, but not 10 mg, reduced depression scores more than a 1 mg control dose over three weeks in adults with treatment-resistant depression. In this phase 2 trial, 233 participants were randomly assigned to 25 mg, 10 mg, or 1 mg of synthetic psilocybin with psychological support. The 25 mg group showed an average 12-point drop on the MADRS depression scale versus a 5.4-point drop in the 1 mg group, a significant difference. The 10 mg group did not differ significantly from control. Response and remission rates at three weeks supported the primary result, but sustained response at 12 weeks was not significantly different.
Therapeutic Advances in Psychopharmacology
January 1, 2020
Matthew Butler, Mathieu Seynaeve, Timothy R. Nicholson et al.
38 citations
Functional neurological disorder (FND), previously called conversion disorder, is common in neurology clinics and causes substantial disability, but treatment options are limited. Psychedelics like psilocybin and LSD may help by altering brain circuits involved in self-representation, which is thought to be disrupted in FND. A systematic review of nine studies from 1954 to 1967, involving 26 patients, found that most received psychotherapy with variable adjunctive psychedelic use (psycholytic therapy). Of those treated, 69% (18 patients) showed at least some recovery on subjective clinician-rated criteria. Adverse events were mostly mild, though one patient withdrew due to distressing effects. All studies were low quality, lacking controls and valid outcome measures, so no conclusions on efficacy can be drawn.
Journal of psychopharmacology (Oxford, England)
August 1, 2024
James Jonathan Rucker, Claire Roberts, Mathieu Seynaeve et al.
32 citations
A new intranasal formulation of 5-MeO-DMT, called BPL-003, was tested in 44 healthy people who had never used psychedelics. Doses up to 12 mg were well tolerated, with no serious side effects; common mild effects included nasal discomfort, nausea, headache, and vomiting. The drug was absorbed quickly, reaching peak levels in about 8–10 minutes, and cleared from the body in under 27 minutes. Higher doses produced stronger subjective drug intensity and mystical experiences, with 60% of participants reporting a 'complete mystical experience' at 10 and 12 mg. The rapid onset and short duration suggest potential for treating conditions like depression.
Headache The Journal of Head and Face Pain
September 20, 2024
James Rucker, Sadie Hambleton, Catherine Bird et al.
12 citations
A small open-label trial tested low doses of psilocybin (5, 7.5, and 10 mg) with psychological support in four patients with chronic short-lasting unilateral neuralgiform headache attacks (SUNHA), a severe headache disorder. The study was terminated early due to recruitment difficulties; three participants completed all sessions. No significant adverse events occurred. Cognitive testing during the acute drug experience was not possible because participants reported high subjective dose intensity. Headache impact remained severe throughout the trial. Mean daily attack frequency decreased by more than 50% in two participants at final follow-up. Thematic analysis of clinical notes suggested psychological insights, including reconfigured relationships to headache pain, were key features of participants' experience. The clinical results provide no conclusive evidence for psilocybin in SUNHA.
Addiction
December 10, 2025
John Marsden, Michael Kelleher, Fiona Dunbar et al.
2 citations
A single 10 mg intranasal dose of the psychedelic drug BPL-003 (a formulation of 5-MeO-DMT) combined with cognitive behavioral therapy was safe and tolerable in people with moderate-to-severe alcohol use disorder. Over 12 weeks, the average percentage of abstinent days increased from 33.2% at baseline to 80.8%, and heavy drinking days dropped from 56.2% to 13.2%. Half of the 12 participants who completed the study were continuously abstinent, a quarter had meaningful reductions in drinking, and a quarter showed little change. Measures of craving, well-being, and quality of life also improved. The findings support larger controlled trials.
Biological Psychiatry
April 10, 2023
James Rucker, Mathieu Seynaeve, Allan H. Young et al.
1 citation
Nasal administration of tryptamine psychedelics significantly elevates mood in 70% of participants, based on a sample size of 150 individuals. This method enhances the effects on consciousness and psychological well-being, indicating strong potential in pharmacology and psychiatry. The study highlights how these substances influence neurotransmitter receptors, leading to altered states of awareness. With implications for forensic toxicology and drug analysis, findings suggest that psychedelics may offer new avenues for therapeutic applications in mental health.
Journal of Psychopharmacology
February 27, 2026
Claire T. Roberts, Mathieu Seynaeve, Anna O. Ermakova et al.
A single dose of BPL-003, a psychedelic drug given as a nasal spray, was safe in people with treatment-resistant depression. Depression scores dropped quickly and stayed lower for 12 weeks, suggesting the drug may help this hard-to-treat condition. Larger controlled trials are needed.
American Journal of Therapeutics
February 20, 2026
Burton J. Tabaac, Kenneth Shinozuka, Anne Weisman et al.
5-MeO-DMT, an ultra-short-acting psychedelic, shows promise for treating depression that does not respond to other therapies, as well as other psychiatric conditions. This evidence supports the need for larger randomized controlled trials to further investigate its effectiveness.
Burton J. Tabaac, Kenneth Shinozuka, Anne Weisman et al.
preprint
5-MeO-DMT, a psychedelic found in toad venom and some plants, shows rapid antidepressant effects in early clinical trials. A Phase 2b trial reported that 57.5% of participants with treatment-resistant depression achieved remission within eight days. Other Phase 2a and 2b trials suggest it may reduce depressive symptoms more effectively than existing treatments like SSRIs. The substance appears low-risk in controlled settings, though most studies are small and only two double-blind randomized controlled trials have been conducted in clinical populations. Long-term effects need further study, and its possible link to near-death experiences remains debated.