Hum Brain Mapp
July 1, 2026
Lorenzo Pasquini, Jakub Vohryzek, Anira Escrichs et al.
Modeled Long-Term Effects of Psilocybin on Dynamic Activity and Effective Connectivity of Fronto-Striatal-Thalamic Circuits.
Philosophical Psychology
April 10, 2026
Eric Rundquist, Diego Nicolás Monasterio López, Juan Jonathan Oyarzo Alvarado et al.
This article presents the results of a Cognitive Linguistic analysis of metaphors used in a series of interviews by a single healthy volunteer following four moderate-to-high dosing sessions with psilocybin. The interviews were conducted by members of a human psychedelic research lab in a deep-sampling fMRI and EEG brain imaging study, allowing the participant to recount experiences under the...
European Journal of Psychotraumatology
December 1, 2025
Gabrielle Agin-Liebes, Richard J. Zeifman, Jennifer Mitchell
11 citations
Background: Posttraumatic stress disorder (PTSD) is a severe condition often complicated by co-occurring disorders, such as major depression, alcohol use disorder, and substance use disorders. A well-powered phase 3 randomized, placebo-controlled trial has shown that MDMA-assisted therapy (MDMA-AT) may be an effective treatment for severe PTSD. However, the psychological mechanisms driving the...
Current Topics in Behavioral Neurosciences
November 22, 2025
Maha N. Mian, Allison R. Coker, Grace Kretzer et al.
Alongside the important contributions of the harm reduction movement to improving public health in secular settings, communities that use psychedelics as religious sacraments (i.e., entheogens) have developed their own frameworks for supporting safety within their spiritual practices and hold their own conceptualizations of risk and harm. In order to understand better the lived realities of...
J Psychoactive Drugs
November 10, 2025
Nicky J. Mehtani, Maha N. Mian, Gabrielle Agin-Liebes et al.
1 citation
Psychedelic Augmentation of 12-Step Engagement: A Novel, Accessible Approach to Enhance Community-Based Recovery from Substance Use Disorders.
Psychedelics
August 5, 2025
Elliot Marseille, Jennifer Mitchell
2 citations
This commentary examines a recent Lykos Therapeutics-funded cost-effectiveness analysis of MDMA-assisted therapy for PTSD following FDA's 2024 decision to decline approval. While methodologically rigorous in its use of empirical trial data, the study has two critical limitations that undermine its relevance to healthcare decision-makers: an inappropriate comparison to placebo-based therapy...
BMJ Open
August 1, 2025
Nicky J. Mehtani, B. Anderson, Irina Alexander et al.
INTRODUCTION: Methamphetamine use disorder (MeUD) is a debilitating condition with no FDA-approved pharmacotherapies that has been associated with poor neurological, psychiatric and cardiovascular outcomes, particularly among low-income populations. The use of methamphetamine also increases risks for sexually transmitted infections (STIs) by reducing behavioural inhibitions while enhancing...
Nature Mental Health
May 1, 2025
Daniel H. Grossman, Kevin R. Madden, Nicky J. Mehtani et al.
10 citations
Socioeconomic status (SES) substantially influences mental health outcomes and treatment access, yet its reporting in psychedelic-assisted therapy trials remains underexplored. Here we systematically reviewed 98 articles (49 primary trials and 49 secondary analyses) published between 2006 and 2024 examining classic psychedelics and MDMA for mental health conditions. Only 12% of primary trials...
bioRxiv (Cold Spring Harbor Laboratory)
November 7, 2024
Lorenzo Pasquini, Jakub Vohryzek, Anira Escrichs et al.
4 citations
preprint
Abstract Psilocybin has been shown to induce fast and sustained improvements in mental well-being across various populations, yet its long-term mechanisms of action are not fully understood. Initial evidence suggests that longitudinal functional and structural brain changes implicate fronto-striatal-thalamic (FST) circuitry, a broad system involved in goal-directed behavior and motivational...
Nat Med
November 1, 2024
Jennifer Mitchell, Marcela Ot’alora G., Bessel Van der Kolk et al.
4 citations
In the version of the article initially published, some members of the MAPP2 Study Collaborator Group were listed only in the Supplementary Information. Charlotte Harrison, Berra Yazar-Klosinski, Wael Garas, Darrick May, Cole Marta, Susan Walker, Elizabeth Nielson, Gregory Wells, Randall Brown, Revital Amiaz, Yair Wallach, Ray Worthy, Alia Lilienstein and Amy Emerson have now been added to the...
Scientific Reports
August 2, 2024
Jennifer Mitchell, Nicky J. Mehtani, Mallory O. Johnson et al.
9 citations
Abstract As a proposed mediator between stigma-related stressors and negative mental health outcomes, HIV-related shame has been predictive of increased rates of substance use and difficulties adhering to antiretroviral treatment among people with HIV. These downstream manifestations have ultimately impeded progress toward national goals to End the HIV Epidemic , in part due to limited success...
Journal of Psychoactive Drugs
2024
Kelan Thomas, Robert L. Jesse, Nicky J. Mehtani et al.
4 citations
In recent years, policymakers have proposed and implemented regulatory changes promoting the deprioritization, decriminalization, or state-level legalization of one or more psychedelic substances, usually referencing data from clinical trials as reasons to support liberalizing drug control policies. As psychedelic policies continue to be drafted, personal possession limits may be considered for...
Nature Medicine
October 1, 2023
Jennifer Mitchell, Marcela Ot’alora G., Bessel Van der Kolk et al.
400 citations
This multi-site, randomized, double-blind, confirmatory phase 3 study evaluated the efficacy and safety of 3,4-methylenedioxymethamphetamine-assisted therapy (MDMA-AT) versus placebo with identical therapy in participants with moderate to severe post-traumatic stress disorder (PTSD). Changes in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total severity score (primary endpoint) and...
Neuropsychopharmacology
July 21, 2023
Jennifer Mitchell, Brian T Anderson
47 citations
The clinical investigation of psychedelic medicines has blossomed over the last 5 years. Data from a Phase 3 industry trial and a multicenter Phase 2 industry trial, in addition to multiple early phase investigator-initiated and industry trials, have now been published in peer-reviewed journals. This narrative review summarizes both the recent data and the current clinical trials that are being...
Focus (American Psychiatric Publishing)
July 1, 2023
Jennifer Mitchell, Michael P. Bogenschutz, Alia Lilienstein et al.
97 citations
Post-traumatic stress disorder (PTSD) presents a major public health problem for which currently available treatments are modestly effective. We report the findings of a randomized, double-blind, placebo-controlled, multi-site phase 3 clinical trial (NCT03537014) to test the efficacy and safety of 3,4-methylenedioxymethamphetamine (MDMA)-assisted therapy for the treatment of patients with...
PLoS One
February 25, 2022
Elliot Marseille, Jennifer Mitchell, James G. Kahn
49 citations
Background Severe posttraumatic stress disorder (PTSD) is a prevalent and debilitating condition in the United States. and globally. Using pooled efficacy data from six phase 2 trials, therapy using 3,4-methylenedioxymethamphetamine (MDMA) appeared cost-saving from a payer’s perspective. This study updates the cost-effectiveness analysis of this novel therapy using data from a new phase 3...
Drug and Alcohol Dependence
February 1, 2022
Christopher R. Nicholas, Julie B. Wang, Allison R. Coker et al.
67 citations
Background Post-traumatic stress disorder (PTSD) is commonly associated with alcohol and substance use disorders (ASUD). A randomized, placebo-controlled, phase 3 trial demonstrated the safety and efficacy of MDMA-assisted therapy (MDMA-AT) for the treatment of severe PTSD. This analysis explores patterns of alcohol and substance use in patients receiving MDMA-AT compared to placebo plus...
Nature Medicine
June 1, 2021
Jennifer Mitchell, Michael P. Bogenschutz, Alia Lilienstein et al.
965 citations
Post-traumatic stress disorder (PTSD) presents a major public health problem for which currently available treatments are modestly effective. We report the findings of a randomized, double-blind, placebo-controlled, multi-site phase 3 clinical trial (NCT03537014) to test the efficacy and safety of 3,4-methylenedioxymethamphetamine (MDMA)-assisted therapy for the treatment of patients with...
Journal of Neuroscience
November 30, 2020
Danilo de Gregorio, Argel Aguilar-Valles, Katrin H. Preller et al.
258 citations
A revamped interest in the study of hallucinogens has recently emerged, especially with regard to their potential application in the treatment of psychiatric disorders. In the last decade, a plethora of preclinical and clinical studies have confirmed the efficacy of ketamine in the treatment of depression. More recently, emerging evidence has pointed out the potential therapeutic properties of...
EClinicalMedicine
September 24, 2020
B. Anderson, Alicia Danforth, Prof Robert Daroff et al.
271 citations
BACKGROUND: Psilocybin therapy has shown promise as a rapid-acting treatment for depression, anxiety, and demoralization in patients with serious medical illness (e.g., cancer) when paired with individual psychotherapy. This study assessed the safety and feasibility of psilocybin-assisted group therapy for demoralization in older long-term AIDS survivor (OLTAS) men, a population with a high...
Robin Carhart-Harris, Will Alexander Lucas, Lorenzo Pasquini et al.
preprint
This article spotlights problematic assumptions and practices in clinical psychedelic research that together hamper the field’s ability to demonstrate causal identification, contributing to confusion and misunderstanding: (1) the main problematic assumption is that pretreatment expectancy causes therapeutic response; while expectancy predicts response to most treatments, it is becoming...