Nature medicine
October 1, 2023
Jennifer M. Mitchell, Marcela Ot’alora G., Bessel Van der Kolk et al.
400 citations
In a phase 3 trial, MDMA-assisted therapy reduced PTSD symptoms and functional impairment more than placebo with therapy in 104 participants with moderate to severe PTSD. The average decrease in PTSD symptom severity was 23.7 points with MDMA-assisted therapy versus 14.8 points with placebo, and functional disability improved by 3.3 versus 2.1 points. Participants were ethnoracially diverse, with 27% identifying as Hispanic/Latino and 34% as other than White. Severe side effects occurred in 9.4% of the MDMA group and 3.9% of the placebo group; no deaths or serious adverse events were reported. The treatment was generally well tolerated.
Neuropsychopharmacology
July 21, 2023
Jennifer M. Mitchell, Brian T. Anderson
47 citations
Over the last five years, clinical research into psychedelic medicines has expanded rapidly, with data from a Phase 3 industry trial, a multicenter Phase 2 industry trial, and multiple early-phase trials now published in peer-reviewed journals. This narrative review summarizes recent findings and ongoing clinical trials involving various classes of psyche-manifesting substances that may help treat a broad range of conditions. The review also discusses methodological considerations, unique challenges, and next steps for research, emphasizing the experiential nature of these therapies.
Nature Mental Health
May 1, 2025
Daniel H. Grossman, Kevin R. Madden, Nicky J. Mehtani et al.
10 citations
Socioeconomic status (SES) strongly affects mental health outcomes and treatment access, but its reporting in psychedelic-assisted therapy trials is inadequate. A systematic review of 98 articles (49 primary trials and 49 secondary analyses) from 2006 to 2024 found that only 12% of primary trials reported participant income data, and 31% reported educational attainment. In US-based trials, participants had markedly higher SES than the general population: 93% had some college education (versus 62% nationally), and median incomes in major trials substantially exceeded the national median for all workers. Non-US trials showed variable patterns. This underreporting and evidence of socioeconomic disparities highlights an urgent need for standardized SES reporting and strategies to improve socioeconomic diversity in psychedelic-assisted therapy research.
Nat Med
November 1, 2024
Jennifer M. Mitchell, Marcela Ot’alora G, Bessel Van der Kolk et al.
4 citations
No Summary
J Psychoactive Drugs
November 10, 2025
Nicky J. Mehtani, Maha N. Mian, Gabrielle Agin-Liebes et al.
1 citation
A novel approach combines psychedelic therapy with 12-step programs to improve engagement in community-based recovery from substance use disorders. The authors argue that psychedelics may enhance openness, spiritual experiences, and social bonding, which could increase participation in 12-step meetings and practices. This accessible strategy aims to leverage existing recovery communities, potentially broadening treatment options without requiring extensive clinical infrastructure. The paper presents a theoretical framework for integrating these modalities, suggesting that such augmentation could improve outcomes for individuals with substance use disorders, though empirical evidence is not provided.
Hum Brain Mapp
July 1, 2026
Lorenzo Pasquini, Jakub Vohryzek, Anira Escrichs et al.
A computational model predicts that a single dose of psilocybin can produce lasting changes in the dynamic activity and effective connectivity of fronto-striatal-thalamic brain circuits. The modeling suggests that psilocybin may strengthen connectivity between the prefrontal cortex and striatum while altering thalamic gating, effects that persist beyond the acute drug experience. These changes could underlie the sustained therapeutic benefits observed in clinical settings, such as reduced depressive symptoms and increased psychological flexibility. The findings provide a mechanistic framework for understanding how psilocybin induces long-term neural plasticity and highlight potential circuit targets for treating psychiatric disorders.