Abstract Psychiatric trials typically define success as symptom reduction, yet patients prioritize meaning, vitality, and functioning. This imbalance undervalues experiential benefits, distorting clinical, policy, and FDA decisions. Psychedelic trials illustrate this, where robust well-being gains sometimes accompany modest symptom effects. We argue well-being should be elevated to co-primary...
Informed by a community engagement process, we have developed a pragmatic, open-label, hybrid feasibility-implementation study of Group Psilocybin-Assisted Therapy (GPAT) for post-traumatic stress disorder (PTSD). As psychedelic-assisted therapies begin to enter the broader mental health arena, engaging communities in the design of research and care models is essential to ensuring that those...
Background: As public and scientific interest in psychedelics grows, unsupervised use for health purposes is increasing. In the U.S., past-year hallucinogen use nearly doubled from 2015 to 2023. Many individuals report self-treating physical or psychological symptoms without medical supervision using psychedelics—a practice termed self-medication. Despite this trend, review-level syntheses...
Mental health disorders (MHD) rank among the top 10 global causes of disease burden, with significant economic and social costs. Current treatments often have limited efficacy or tolerability, and there has been little recent innovation in treatments. In the past decade, clinical research on Psychedelic-Assisted Therapies (PAT) for treating MHD has increased in high-income countries, while most...
Abstract Psilocybin-assisted therapy (PAT) has been shown in early trials to reduce the symptoms of treatment-resistant depression (TRD). This study evaluated the cost-effectiveness of PAT as a third-line treatment for major depressive disorder compared to standard of care (SOC). We used an individual-level, probabilistic simulation model that portrays representative US adults with TRD who...
ABSTRACT The war in Ukraine has led to widespread trauma, with 6.4 million people suffering from severe, chronic posttraumatic stress disorder (PTSD). This study evaluates the cost‐effectiveness and societal impact of implementing modified group MDMA‐assisted therapy (MAT), with supplemental individual therapy for PTSD treatment in Ukraine. Using a decision analysis model, we estimated clinical...
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...
Few population-based studies have examined associations between psychedelic use and mental health outcomes. This work describes characteristics of exclusive psychedelic mushroom use (referred to as PM use), PMs in combination with other psychedelic substances (multi-psychedelic or MP) use, and non-psychedelic use and explores mental health ratings in non-clinical settings. This work uses...
This study aims to estimate the lower, middle, and upper bounds of potential demand for psilocybin-assisted therapy (PSIL-AT) for major depressive disorder (MDD) and treatment-resistant depression (TRD) in the United States. We calculated potential PSIL-AT demand for MDD and TRD by estimating the number of U.S. patients with MDD, identifying those in treatment, and determining who qualifies as...
Objective To compare group and individual psychedelic-assisted therapy in terms of clinician time, costs and patient access. Methods Using 2023 data from two group therapy trial sites, one using 3,4-Methylenedioxymethamphetamine (MDMA) to treat posttraumatic stress disorder (PTSD), and one using psilocybin to treat major depressive disorder (MDD), we compared overall variable costs, clinician...
After a long hiatus, psychiatry is undergoing a resurgence of interest in psychedelic drugs as therapy for a wide range of mental health disorders Accumulating clinical evidence suggests substantial potential for psychedelics used in a therapeutic context, as treatment for, among other disorders, depression, post-traumatic stress disorder (PTSD), and addictions to tobacco, opioids and alcohol....
Intensive psychotherapy assisted with 3,4-methylenedioxymethamphetamine (MDMA-AT) was shown in Phase 3 clinical trials to substantially reduce post-traumatic stress disorder (PTSD) symptoms compared to psychotherapy with placebo. This study estimates potential costs, health benefits, and net savings of expanding access to MDMA-AT to eligible US patients with chronic and severe PTSD. Using a...
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...
Background Chronic posttraumatic stress disorder (PTSD) is a disabling condition that generates considerable morbidity, mortality, and both medical and indirect social costs. Treatment options are limited. A novel therapy using 3,4-methylenedioxymethamphetamine (MDMA) has shown efficacy in six phase 2 trials. Its cost-effectiveness is unknown. Methods and findings To assess the...