MDMA-Assisted Therapy for Severe PTSD: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study

Mitchell, Jennifer; Bogenschutz, Michael P.; Lilienstein, Alia; Harrison, Charlotte; Kleiman, Sarah E.; Parker-Guilbert, Kelly; G., Marcela Ot’alora; Garas, Wael; Paleos, Casey; Gorman, Ingmar; Nicholas, Christopher R.; Mithoefer, Michael C.; Carlin, Shannon; Poulter, Bruce; Mithoefer, Ann T; Quevedo, Sylvestre; Wells, Gregory; Klaire, Sukhpreet; Kolk, Bessel van der; Tzarfaty, Keren; Amiaz, Revital; Worthy, Ray; Shannon, Scott; Woolley, Joshua; Marta, Cole J.; Gelfand, Yevgeniy; Hapke, Emma; Wallach, Yair; Brown, Randall; Hamilton, Scott; Coker, Allison; Matthews, Rebecca; Boer, Alberdina de; Yazar‐Klosinski, Berra; Emerson, Amy; Doblin, Rick

doi:10.1176/appi.focus.23021011

Cited by 29 publications

(6 citation statements)

References 38 publications

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“…The treatment involves a series of therapy sessions, including preparatory and integration sessions, to ensure the consolidation and application of insights gained during MDMA-assisted sessions [108]. In addition, beyond reducing symptoms, MDMA-assisted psychotherapy has been shown to enhance therapeutic processes [113]. The empathogenic and entactogenic effects of MDMA help individuals with PTSD develop a sense of safety and trust within the therapeutic setting, facilitating the exploration and processing of traumatic memories and emotions that are often at the core of their condition [111].…”

Section: Discussionmentioning

confidence: 99%

MDMA-Based Psychotherapy in Treatment-Resistant Post-Traumatic Stress Disorder (PTSD): A Brief Narrative Overview of Current Evidence

Riaz,

Suneel,

Hamza Bin Abdul Malik

et al. 2023

Diseases

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Post-traumatic stress disorder (PTSD) is a debilitating mental health disorder that causes significant dysfunction in individuals. Currently, there are many approved pharmacotherapy and psychotherapy treatment options for PTSD, but unfortunately, half of the patients do not respond to traditional therapies. In this article, we review clinical trials and research on 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy in PTSD patients, its pharmacokinetics, and current treatment guidelines for PTSD. Our findings are based on the results of the efficacy of MDMA-assisted psychotherapy from six phase II randomized controlled trials. MDMA-assisted psychotherapy for PTSD has received the “breakthrough therapy” designation from the FDA. MDMA can reduce PTSD symptoms even in treatment-resistant cases by increasing certain neurohormones, i.e., dopamine, serotonin, norepinephrine, and oxytocin. It also modulates activities in the brain regions involved in fear and anxiety. Future research is needed to show whether the advantages outweigh the disadvantages and whether its use can be integrated into available treatment options for PTSD.

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Section: Discussionmentioning

confidence: 99%

MDMA-Based Psychotherapy in Treatment-Resistant Post-Traumatic Stress Disorder (PTSD): A Brief Narrative Overview of Current Evidence

Riaz,

Suneel,

Hamza Bin Abdul Malik

et al. 2023

Diseases

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“…The cleaving of the connection between assumptions and understandings of 'self' and 'other' lies at the heart of systemic oppression. Dualistic assumptions of self and other justify white supremacist thinking, violence against women, and exploitation of the earth (Mitchell et al 2020).…”

Section: The Promises and Challenges Of Contemporary Psychedelic Workmentioning

confidence: 99%

“…When everything is interconnected, encounters with seemingly antithetical or unbelievable phenomena co-existing together are framed as an opportunity to grow and develop. What if, not only circular in nature, the image of the Ouroboros was also a Möbius strip: a geometrical shape that appears to be two-sided, but in fact is one contiguous strip (Mitchell et al 2020)? Paradox is the meeting point of the two sides at the horizon of the view of the perceiver.…”

Section: The Potential Answer Of Nondualismmentioning

confidence: 99%

Mysticizing medicine: incorporating nondualism into the training of psychedelic guides

McCarroll

2022

Interdisciplinary Science Reviews

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Today, practitioners of contemporary psychedelic medicine are faced with a unique challenge: supporting clients in integrating transpersonal and mystical experiences within a paradigm based on a materialistic, reductionist, and dualistic understanding of reality. Operating on assumptions of pathology and problemsolving, the Western medical model often lacks the theoretical basis to make sense of and integrate the full potentiality of psychedelic medicine. Nondualism can offer an alternative guide to engaging with and transmuting the beliefs and traumas that lie at the root of paradigms based on assumptions of separation. These frames can be deeply resourcing for both psychedelic guide and client. This article explores the challenges and limitations of the modern Western paradigm, as well as possibilities for how nondualism could be incorporated into future training of psychedelic guides.

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“…Psychedelic-assisted therapy (PAT) has demonstrated success in treating a variety of mental health conditions, including major depressive disorder (MDD), 1 treatment-resistant depression (TRD), 2 substance use disorder, 3 , 4 post-traumatic stress disorder (PTSD), 5 , 6 and existential anxiety at end of life. 6 , 7 The U.S. Food and Drug Administration has designated 3,4-methylenedioxy-methamphetamine (MDMA) and psilocybin—one of the psychoactive components in “magic” mushrooms—as breakthrough therapies for PTSD and MDD, respectively.…”

Section: Introductionmentioning

confidence: 99%

Persons With Spinal Cord Injury Report Peripherally Dominant Serotonin-Like Syndrome After Use of Serotonergic Psychedelics

Abrams,

Rabinovitch,

Zafar

et al. 2023

Neurotrauma Reports

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Psychedelic-assisted therapy (PAT) may treat various mental health conditions. Despite its promising therapeutic signal across mental health outcomes, less attention is paid on its potential to provide therapeutic benefits across complex medical situations within rehabilitation medicine. Persons with spinal cord injury (SCI) have a high prevalence of treatment-resistant mental health comorbidities that compound the extent of their physical disability. Reports from online discussion forums suggest that those living with SCI are using psychedelics, though the motivation for their use is unknown. These anecdotal reports describe a consistent phenomenon of neuromuscular and autonomic hypersensitivity to classical serotonergic psychedelics, such as psilocybin and lysergic acid diethylamide (LSD). Persons describe intense muscle spasms, sweating, and tremors, with an eventual return to baseline and no reports of worsening of their baseline neurological deficits. The discomfort experienced interferes with the subjective beneficial effects self-reported. This phenomenon has not been described previously in the academic literature. We aim to provide a descriptive review and explanatory theoretical framework hypothesizing this phenomenon as a peripherally dominant serotonin syndrome-like clinical picture—that should be considered as such when persons with SCI are exposed to classical psychedelics. Raising awareness of this syndrome may help our mechanistic understanding of serotonergic psychedelics and stimulate development of treatment protocols permitting persons with SCI to safely tolerate their adverse effects. As PAT transitions from research trials into accepted clinical and decriminalized use, efforts must be made from a harm reduction perspective to understand these adverse events, while also serving as an informed consent process aid if such therapeutic approaches are to be considered for use in persons living with SCI.

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MDMA-Assisted Therapy for Severe PTSD: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study

Cited by 29 publications

References 38 publications

MDMA-Based Psychotherapy in Treatment-Resistant Post-Traumatic Stress Disorder (PTSD): A Brief Narrative Overview of Current Evidence

MDMA-Based Psychotherapy in Treatment-Resistant Post-Traumatic Stress Disorder (PTSD): A Brief Narrative Overview of Current Evidence

Mysticizing medicine: incorporating nondualism into the training of psychedelic guides

Persons With Spinal Cord Injury Report Peripherally Dominant Serotonin-Like Syndrome After Use of Serotonergic Psychedelics

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