Archives of General Psychiatry
September 7, 2010
Gurpreet S Chopra, Marycie Hagerty, Charles S. Grob et al.
1,220 citations
In a double-blind, placebo-controlled study, twelve adults with advanced-stage cancer and anxiety received a moderate dose (0.2 mg/kg) of psilocybin. Safe physiological and psychological responses were documented, with no clinically significant adverse events. The State-Trait Anxiety Inventory trait anxiety subscale showed a significant reduction in anxiety at 1 and 3 months after treatment. The Beck Depression Inventory indicated improved mood that reached significance at 6 months; the Profile of Mood States showed mood improvement that approached but did not reach significance. The results support the need for more research into psilocybin for cancer-related anxiety.
Psychopharmacology
November 1, 2018
Alicia Danforth, Charles S. Grob, Christopher M Struble et al.
284 citations
Autistic adults with severe social anxiety who received MDMA-assisted psychotherapy showed significantly greater improvement in social anxiety symptoms compared to those given an inactive placebo. The improvement was rapid and durable, with effects still present at a six-month follow-up. The study used two eight-hour psychotherapy sessions with either MDMA (75–125 mg) or placebo, plus three non-drug sessions after each. The effect size was very large at the primary endpoint and remained large at follow-up. Social anxiety stayed the same or continued to improve for most in the MDMA group after treatment ended. Initial safety and efficacy support larger studies.
EClinicalMedicine
September 24, 2020
B. Anderson, Alicia Danforth, Prof Robert Daroff et al.
271 citations
Psilocybin-assisted group therapy is feasible, relatively safe, and potentially effective for reducing demoralization in older long-term AIDS survivor (OLTAS) gay men, a population with high levels of demoralization and traumatic loss. In an open-label study, participants with moderate-to-severe demoralization received 8-10 group therapy visits and one psilocybin administration (0.3-0.36 mg/kg). The primary clinical outcome showed a reduction in demoralization from baseline to end-of-treatment and to 3-month follow-up, with a moderate effect size (partial eta-squared = 0.47, 90% CI 0.21-0.60). Groups may offer an efficient model for delivering psychotherapy alongside psilocybin to patients with complex needs.
Progress in neuro-psychopharmacology & biological psychiatry
January 4, 2016
Alicia Danforth, Christopher M Struble, Berra Yazar-Klosinski et al.
110 citations
A clinical trial of MDMA-assisted therapy for social anxiety in autistic adults began in spring 2014. MDMA has been administered to over 1133 individuals in research without unexpected serious adverse events requiring expedited FDA reporting. The authors argue that established safety parameters justify developing MDMA-assisted interventions to help autistic adults improve social adaptability. MDMA, like classic psychedelics, can catalyze lasting openness and introspection without ongoing administration, reducing adverse event frequency and improving the risk/benefit ratio compared to daily medications. Clinicians could employ new treatment models using one to several MDMA sessions within supportive psychotherapy for social anxiety or similar distress.
Lancet Psychiatry
October 1, 2020
Brian T Anderson, Alicia Danforth, Charles S. Grob
99 citations
The text discusses safety and ethical concerns surrounding psychedelic medicine, emphasizing the need for stringent oversight, comprehensive patient screening, robust therapeutic support, and informed consent to mitigate risks such as psychological distress and misuse. It highlights the ethical imperative for equitable access and responsible medical use as these powerful medicines are integrated into clinical practice.
Neuropharmacology
August 13, 2022
Ingrid Donato, Veronica Magar, Sean J Belouin et al.
49 citations
Psychedelic and entactogen medicines like psilocybin and MDMA, when combined with psychosocial support, show potential for safe, rapid, and durable clinical improvements. Both have received Breakthrough Therapy designation from the US FDA and may gain full approval, with similar regulatory steps in other countries. Regulatory changes are also increasing access to legal or decriminalized psychedelic use outside medical settings. This review covers historical use, current evidence, and policy considerations around standards of practice, consumer protection, community engagement, equitable access, and data standards. It suggests a public-private partnership involving diverse stakeholders to co-create best practices and public policies supporting responsible, ethical use.
Psychedelic Medicine
January 20, 2025
Marianna Graziosi, Gabrielle Agin-Liebes, Mary P Cosimano et al.
9 citations
Psilocybin and other serotonergic psychedelics are used in research settings with safety measures including controlled environments, staff presence, screening, and psychoeducation. An analysis of study materials from psilocybin trials over the past two decades found that psychoeducation documents varied but commonly emphasized biological and physical safety, psychological safety and well-being, aspects of setting, and the potential for expectancies. The materials prioritized biological and psychological safety across all sites. The authors also identified elements unrelated to safety that may contribute to participant expectancies and suggest these extrapharmacological factors be studied systematically to maximize safety while minimizing extraneous expectancies.
Current Topics in Behavioral Neurosciences
January 1, 2021
Alicia Danforth
5 citations
Autistic self-advocates are using the Internet to influence the conversation about neurodiversity and the potential benefits of psychedelic medicine for autistic adults, given the lack of effective mental health treatment options. Autism is a genetically-determined neurocognitive variant, so psychedelics cannot cure or alter its course. However, autism frequently co-occurs with conditions like anxiety, depression, obsessive-compulsive disorder, and trauma, which are being studied as indications for psychedelic clinical trials. This chapter informs researchers and clinicians about the history of clinical research with classic psychedelics in autistic minors, recent trials of atypical psychedelics in autistic adults, and considerations for providing autism-compatible psychedelic-assisted psychotherapies.
Biological Psychiatry
May 1, 2019
Brian T Anderson, Alicia Danforth, Robert Daroff et al.
5 citations
No Summary
Journal of psychopharmacology (Oxford, England)
June 10, 2025
Torsten Passie, Anja Loizaga-Velder, Alicia Danforth et al.
4 citations
A consensus-based model curriculum for education and training in substance-assisted psychotherapy (SAP) covers theoretical topics and practical components including apprenticeship observation, ongoing clinical supervision, and self-experience for trainees. The model, developed by authors with extensive SAP experience, also addresses peer and conventional supervision, respect for intercultural differences, and teachings about indigenous use of related substances. It is largely adapted to western industrialized countries with established graduate-level psychotherapy training. The curriculum may be valuable for psychedelic researchers, those training therapists for research studies, and those preparing for clinical work outside research settings.
Journal of Health Service Psychology
December 1, 2025
Philip Garrity, Alicia Danforth, Brian T Anderson et al.
1 citation
Psilocybin shows promise in enhancing well-being for patients with terminal illnesses. In a clinical trial involving 50 participants, 80% reported significant improvements in existential distress and quality of life after receiving psilocybin therapy. This innovative approach combines traditional medicine with psychosocial support, suggesting that psychedelics can bridge gaps in palliative care. Participants also experienced altered interpretations of their pain and meaning in life, highlighting the potential of integrating psychedelics into psychological practice to address deep-seated beliefs and existential concerns.
BMJ Open
May 11, 2026
Julia Colcott, Alexandre A. Guerin, Olivia Carter et al.
A new tool, the MDMA-Assisted Psychotherapy Side Effects Tool (M-SET), was developed to systematically capture side effects during MDMA-assisted psychotherapy. Experts in MDMA-AP and neuropsychopharmacology participated in a two-round online Delphi process to refine a list of 165 items across four questionnaires covering screening, baseline, medication session days, and follow-up. The tool aims to improve safety monitoring and build a more robust evidence base on the tolerability of MDMA-AP for research and clinical use.