Psychopharmacology
August 1, 2024
Jacob S Aday, David Horton, Gisele Fernandes-Osterhold et al.
39 citations
Psychedelic-assisted psychotherapy (PAP) shows promise for treating mental health conditions like substance use disorders and depression, yet the role of the psychotherapy component itself has received little empirical scrutiny. This review examines current debates over whether PAP involves full psychotherapy or merely psychological support, and summarizes existing clinical trial models and theoretical frameworks. It draws lessons from traditional psychotherapy research, advocating for standardized treatment manuals, clear provider eligibility criteria, measurement of established mechanisms of change, and optimized trial designs such as dismantling studies and comparative efficacy trials. The authors argue that PAP is a distinct, integrative, transdisciplinary intervention requiring further research into its psychotherapeutic components to inform best practices and federal guidelines.
Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology
April 9, 2025
Ellen R Bradley, Kimberly Sakai, Gisele Fernandes-Osterhold et al.
23 citations
In an open-label pilot trial, 12 people with mild to moderate Parkinson's disease plus depression or anxiety received psilocybin (10 mg then 25 mg) with psychotherapy. No serious adverse events occurred, and no worsening of Parkinson's symptoms was observed. Non-motor and motor symptoms improved, and gains in some cognitive domains were sustained one month later. Depression and anxiety scores improved to a clinically meaningful degree and remained improved three months after dosing. These first results in any neurodegenerative disease suggest psilocybin therapy for Parkinson's disease warrants further study.
Psychiatry research
March 1, 2025
Stephanie L Haft, Amanda E Downey, Marissa Raymond-Flesch et al.
22 citations
A systematic review of 21 randomized controlled trials of psilocybin- and MDMA-assisted therapies (total 1034 participants) found that participant samples lack diversity. Gender was always reported, race or ethnicity in 76% of trials, and socioeconomic status in 57%. Sexual orientation (9.5%) and immigration status (4.8%) were rarely reported; no study reported gender identity. Compared to the US population and non-psychedelic clinical trials, Black/African-American participants (2.2%) and Hispanic/Latino participants (7.2%) were significantly underrepresented. MDMA trials enrolled more diverse samples than psilocybin trials. Analyses of treatment effects by demographic variables were virtually absent. The findings indicate a need for inclusive recruitment and rigorous reporting to improve generalizability.
JAMA psychiatry
March 1, 2025
Michelle Matvey, D Parker Kelley, Ellen R Bradley et al.
12 citations
In psychedelic clinical trials, participants often cannot be masked to whether they received the active drug or placebo, because the drug's effects are so noticeable. This can bias outcomes because participants' expectations influence their responses. One proposed solution is to modify the informed consent process to obscure some details of the study design, which has been used in several recent trials. However, this approach raises serious ethical concerns. The authors review the use of such modifications in trials from 2000 to 2024, discuss the regulatory landscape, and suggest ways to reduce risks. They conclude that modified consent may improve trial interpretability but has not been explicitly tested and may not be appropriate in all cases.
Psychopharmacology
August 1, 2024
Kimberly Sakai, Ellen R Bradley, Joseph A Zamaria et al.
10 citations
People who take SSRIs and use psilocybin mushrooms together often report a less intense psychedelic experience, though many report no change in intensity. About 8% of Reddit posts describing coadministration mention negative physical or psychological effects, including a small number of reports that may indicate serotonin toxicity and one possible psychotic or manic episode. The interactions appear complex and likely depend on multiple factors. Prospective studies are needed to determine whether psilocybin treatments are safe and effective for people using SSRIs.
Drug science, policy and law
January 1, 2026
Jacob S Aday, Zoe Zong, Jonathan Song et al.
A Mandarin version of the Five Dimensional Altered States of Consciousness (5D-ASC) Rating Scale was developed to improve language accessibility for Mandarin-speaking individuals in psychedelic research. The translation followed the ISPOR Task Force guidelines, involving forward translation by two professionals, review by a native Mandarin speaker, back-translation, and comparison with the original. The scale includes 11 facets such as experience of unity, spiritual experience, and anxiety, and can also be analyzed using the original 5-factor structure. The full survey is provided in the appendix. Further research is needed to evaluate its reliability and validity in Mandarin-speaking populations.