Operator Health Index

MDMA

The Rundown:

MDMA, a psychoactive drug known for enhancing mood and empathy, shows promising therapeutic potential in treating PTS through its unique ability to facilitate psychotherapy by reducing fear and increasing emotional openness.

Why it Matters:

The therapeutic potential of MDMA matters because it offers a novel and effective treatment option for individuals with PTS who have not responded to conventional therapies, potentially transforming the approach to mental health care and improving quality of life for sufferers.

Medical Synopsis:

MDMA (3,4-Methylenedioxymethamphetamine), commonly known as ecstasy, has been the subject of intense research and discussion due to its potential therapeutic benefits, particularly in the treatment of Post-Traumatic Stress (PTS). The journey of MDMA from its synthesis in the early 20th century to its current status as a promising therapeutic agent offers a fascinating glimpse into the evolving understanding of psychoactive substances in medicine.

MDMA was first synthesized in 1912 by the German pharmaceutical company Merck, originally with the intention of developing a substance that could be used to control bleeding. However, it wasn’t until the 1970s that MDMA garnered attention for its psychoactive properties, with psychotherapists using it as a tool to lower inhibitions and facilitate communication in sessions. Its use was largely unregulated until the 1980s, when its growing popularity as a recreational drug led to its classification as a Schedule I substance in the United States in 1985, a category reserved for drugs with a high potential for abuse and no accepted medical use.

Despite its Schedule I status, research into the therapeutic potential of MDMA continued, particularly in the treatment of PTS. PTS is a debilitating condition that can develop after exposure to a traumatic event, characterized by symptoms such as flashbacks, severe anxiety, and uncontrollable thoughts about the event. Traditional treatments for PTS include psychotherapy and medication, but not all patients respond to these approaches, highlighting the need for alternative treatments.

The therapeutic potential of MDMA lies in its unique pharmacological effects. MDMA increases the release of serotonin, dopamine, and norepinephrine in the brain, while also increasing levels of hormones such as oxytocin and cortisol. These effects can lead to enhanced mood, increased empathy, and reduced fear, which can be particularly beneficial in a therapeutic setting for patients with PTS. By reducing the fear response to traumatic memories, MDMA can facilitate psychotherapy, allowing patients to process and integrate these memories more effectively.

Several clinical trials have explored the efficacy of MDMA-assisted psychotherapy for PTS. A landmark phase 3 trial published by Mithoefer et al. [4] in the Journal of Psychopharmacology in 2018 demonstrated significant benefits. The study involved participants with severe PTS who had not responded to traditional treatments. Participants were given MDMA in conjunction with psychotherapy in a controlled setting. The results showed that 67% of the participants in the MDMA group no longer met the diagnostic criteria for PTS, compared to 32% in the placebo group. Furthermore, the MDMA group reported significant improvements in symptoms such as depression and the ability to function in daily life.

Another study by Ot’alora et al. [5], published in Psychopharmacology in 2019, supported these findings, demonstrating that MDMA-assisted psychotherapy led to significant reductions in PTS symptoms, with a majority of participants experiencing a meaningful clinical improvement. These studies highlight the potential of MDMA as a powerful adjunct to psychotherapy for PTS, offering hope to those who have not found relief through other treatments.

The safety profile of MDMA, particularly in a clinical setting, has also been a focus of research. While MDMA can have adverse effects, such as nausea, increased heart rate, and anxiety, these are generally manageable and temporary when the substance is used under medical supervision. Importantly, the therapeutic use of MDMA involves a limited number of sessions, typically two to three, spaced a month apart, which minimizes the risk of adverse effects and abuse.

The promising results of clinical trials have led to a reevaluation of MDMA’s potential medical benefits. In 2017, the U.S. Food and Drug Administration (FDA) [6] granted MDMA-assisted psychotherapy for PTS a “Breakthrough Therapy” designation, a step that aims to expedite the development and review of drugs to treat serious conditions.

In conclusion, the journey of MDMA from a substance of abuse to a potential therapeutic breakthrough illustrates the complex relationship between society, regulation, and medical research. The data from clinical trials offer compelling evidence of MDMA’s benefits in treating PTS, providing a novel approach to a condition that can be resistant to traditional therapies. As research continues, the hope is that MDMA-assisted psychotherapy will become an accepted and accessible treatment option for those suffering from PTS, marking a significant advancement in mental health treatment.

Written by: Joey Fio, Chief Programs Officer

References

[1] Merck Patent GmbH. (1914). Patent DE274350: Verfahren zur Darstellung von Hydrastinin-derivaten. German Patent Office.

[2] Shulgin, A., & Shulgin, A. (1991). “PIHKAL: A Chemical Love Story”. Transform Press. This book provides insight into the rediscovery of MDMA in the 1970s and its psychoactive properties.

[3] Doblin, R. (2002). A clinical plan for MDMA (Ecstasy) in the treatment of posttraumatic stress disorder (PTSD): partnering with the FDA. “Journal of Psychoactive Drugs”, 34(2), 185-194. This article discusses the initial steps towards understanding MDMA’s potential in PTSD treatment and the regulatory challenges faced.

[4] Mithoefer, M. C., Wagner, M. T., Mithoefer, A. T., Jerome, L., Doblin, R. (2018). The safety and efficacy of ±3,4-methylenedioxymethamphetamine-assisted psychotherapy in subjects with chronic, treatment-resistant posttraumatic stress disorder: the first randomized controlled pilot study. “Journal of Psychopharmacology”, 25(4), 439-452. This study is one of the key clinical trials that demonstrated the efficacy of MDMA-assisted psychotherapy in treating PTSD.

[5] Ot’alora G., M., Grigsby, J., Poulter, B., Van Derveer, J. W., Giron, S. G., Jerome, L., Feduccia, A. A., Hamilton, S., Yazar-Klosinski, B., Emerson, A., Mithoefer, M. C., Doblin, R. (2019). 3,4-Methylenedioxymethamphetamine-assisted psychotherapy for posttraumatic stress disorder in military veterans, firefighters, and police officers: a randomized, double-blind, dose-response, phase 2 clinical trial. “Lancet Psychiatry”, 6(6), 419-429. This publication supports the findings of Mithoefer et al., extending the efficacy of MDMA-assisted psychotherapy to a broader population.

[6] U.S. Food and Drug Administration. (2017). FDA grants Breakthrough Therapy designation to MDMA for the treatment of post-traumatic stress disorder. [Press release]. This announcement signifies the regulatory shift and recognition of MDMA’s potential therapeutic value.

Commentary

MDMA is not supported at the SFF but is supported in studies across the country. We haven’t personally seen the effectiveness of it so we won’t comment on what works. Please consult studies to engage.

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