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Kelley O'Donnell

2 papers in the library · publishing 2026

Papers

Safety and Efficacy of Psilocybin-Assisted Therapy for Alcohol Use Disorder: Open-Label Extension of a Phase II Randomized Controlled Trial

PsyArXiv March 26, 2026 Broc A Pagni, Stephen Ross, Sarah Mennenga et al. preprint

An open-label extension of a Phase II randomized controlled trial examined the safety and efficacy of psilocybin-assisted therapy for alcohol use disorder. Participants who had received either psilocybin or placebo in the main trial were offered two open-label psilocybin sessions. The treatment was well tolerated, with no serious adverse events attributed to psilocybin. Heavy drinking days decreased substantially from baseline, and the reduction was sustained through the 32-week follow-up. The findings suggest that psilocybin-assisted therapy may produce durable reductions in alcohol consumption among individuals with alcohol use disorder.

The Conceptual Framework for the Therapeutic Approach used in Phase 3 Trials of MDMA-AT for PTSD

Kelley O'Donnell, Michael Alpert, Lauren Okano et al. preprint

MDMA-Assisted Therapy for PTSD uses a short-term, intensive psychotherapy model that includes three sessions facilitated by MDMA along with non-drug therapy sessions. The MDMA helps recall and process traumatic memories and enhances learning in social contexts, integrating top-down and bottom-up trauma care. This paper describes the psychotherapeutic concepts and theories behind this approach, centering on the participant's inner healing intelligence as the main agent of change, with the therapeutic relationship as a core facilitative condition. Phase 2 and 3 trials showed MDMA with therapy outperformed placebo with therapy in reducing PTSD symptoms, though significant symptom reduction also occurred in participants who received only therapy.