New Study Shows Safety and Efficacy of MDMA-Assisted Therapy for Treating PTSD

MDMA’s potential in mental health treatment has been gaining attention once again as researchers continue to study its effects on various mental health disorders like post-traumatic stress disorder (PTSD). While MDMA is often used recreationally, it has shown significant promise as a beneficial medicine to treat PTSD when combined with traditional talk therapy. One of the dominant figures in MDMA research is the Multidisciplinary Association for Psychedelic Studies, which has recently reported the preliminary findings of their multiple-phase study. Their Phase 3 study found positive and long-lasting results in MDMA-assisted therapy for treating PTSD. Soon, the substance could become more available for those who struggle with PTSD and other mental health disorders.

MDMA’s potential to revolutionize mental health treatment

MDMA (3,4-methylenedioxymethamphetamine), also known as ecstasy or Molly, is a synthetic stimulant and hallucinogen that releases neurotransmitters in the brain, creating increased sensations of relaxation, safety, and empathy. The substance is often used outside of a medical setting, though when abused, it can negatively impact the mind, creating decreased brain functioning and sometimes serious side effects like psychosis. Still, when provided by medical professionals in a regulated setting, MDMA has shown significant potential as a beneficial medicine to treat mental health disorders.

In the late 1970s and early 80s, psychiatrists grew interested in the substance as they found that it amplified the communication in their patients, allowing them to obtain deeper insights into their problems. However, in 1985, the DEA defined MDMA as a Schedule I drug with a high potential for abuse and no accepted medical use. MDMA remains a Schedule I controlled substance, but scientists continue to research the drug’s therapeutic potential for treating various mental health conditions.

The  U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to MDMA for the treatment of post-traumatic stress disorder in 2017. This designation means that the FDA recognizes that MDMA can be an effective treatment for the condition and may be more effective than other currently available treatments for PTSD. MDMA has yet to receive FDA approval, though the U.S. Department of Health and Human Services anticipates that the FDA could approve MDMA by 2024 since its breakthrough designation puts the substance on a fast track to becoming a regulated medicine.

Understanding PTSD

Post Traumatic Stress Disorder (PTSD) is a potentially severe mental health disorder that develops in people who have gone through traumatic life events such as assaults, accidents, military combat, or other forms of life-threatening or violent events. These symptoms can appear years after the trauma has occurred, and they vary in severity from person to person. PTSD symptoms can be debilitating, particularly for individuals suffering from severe cases. According to statistics from the U.S. Department of Veterans Affairs, veterans are more likely to develop PTSD than civilians, with 7 out of 100 veterans experiencing PTSD in their lifetime. Additionally, around 6% of Americans will experience PTSD at some point in their lives, though symptoms often subside after treatment. However, people of color, women, and members of the LGBTQ+ community are significantly more likely to develop the disorder in their lifetime, as they tend to have less access to treatment and are less likely to receive a medical diagnosis or the mental healthcare they need. This lack of resources can leave the symptoms of these individuals untreated and at risk of developing further. Studies have found that around 33% of individuals with a PTSD diagnosis have treatment-resistant PTSD since medications, psychiatry, and cognitive behavioral interventions are ineffective treatments to curb the disorder in some patients (1). Furthermore, reports have found that those with chronic PTSD have only an 18% likelihood of recovering (2). 

Advances in MDMA-assisted therapy could provide the resources many treatment-resistant PTSD patients need to recover and have a better quality of life. Unfortunately, access to MDMA is currently limited for many individuals with PTSD since the FDA has not yet approved the substance for medical use. Unless those with PTSD qualify for a clinical trial or leave the U.S. to attend a psychedelic-assisted therapy retreat in a country with more relaxed drug laws, such as Costa Rica, they cannot access MDMA. Nevertheless, as more researchers and organizations study the capabilities and safety of MDMA, the drug could soon be a more widely available option for those who have the condition.

How MAPS is leading the way in MDMA research

One of the leading players in MDMA research is the Multidisciplinary Association for Psychedelic Studies (MAPS), a nonprofit organization that was founded in 1986. They specialize in the research and education of psychedelics and advocate for the development of  “medical, legal, and cultural shifts so people can benefit from the careful use of psychedelics and marijuana for mental health, well-being, and connection.” Since their establishment, MAPS has accumulated more than $130 million in funding for psychedelic research and education. 

Maps Public Benefit Corporation (MAPS PBC) is a subsidiary of MAPS that aims to develop and commercialize prescription psychedelic treatments for those with mental health disorders. MAPS PBC organized several MDMA trials to determine the safety and effectiveness of psychedelic-assisted therapy. The trials have gone through several phases to find the lasting impact of the psychedelic substance, and MAPS PBC has recently published a press release with the interim results of their Phase 3 study.

Promising results of the MAPS MDMA-assisted therapy study

In a recently published news release, MAPS reported the preliminary findings of their MPLONG study, which tested the long-term safety and efficacy of MDMA-assisted therapy for treating PTSD. This study was a follow-up to the MAPP1 and MAPP2 trials of MDMA-assisted therapy. The primary endpoint or objective of the MPLONG study was to evaluate the long-term effectiveness of using MDMA-assisted therapy to treat PTSD. The results were measured through the total severity score of the Clinician-Administred PTSD Scale for DSM (CAPS-5), a standardized test used to diagnose PTSD and measure the severity of symptoms. The key secondary endpoint of the trial was to assess the participant’s functional impairment through the Sheehan Disability Scale (SDS), a self-assessment tool used to measure any limitations that arise from the disorder in work, social, and home responsibilities. Two months after the final therapy session, the results were measured to meet the primary and secondary endpoints of the trial. 

During the Phase 3 studies, participants demonstrated improved and lasting PTSD symptoms for at least six months and sometimes even a year or more following their final session of MDMA-assisted therapy. The results align with the previous Phase 2 clinical trial data that examined the lasting impact of MDMA-assisted psychotherapy in the treatment of PTSD.

The two Phase 3 studies showed significant improvement in participants who received MDMA therapy compared to placebo therapy. Two participants in the placebo-controlled group reported three cases of serious adverse events during the trial, including suicidal behavior and self-hospitalization. However, the study found that the effects of MDMA did not cause any adverse side effects of suicidality or abuse potential, meaning that treatment is relatively safe for therapeutic use (3).

MAPS plans to use the data for a new drug application that will be submitted for the substance’s approval by a regulatory agency, such as the U.S. Food and Drug Administration (FDA). The positive results of the MPLONG study show promise for the future use of MDMA-assisted therapy in treating PTSD, which can be challenging to treat with traditional therapies. 

The possible approval of MDMA-assisted therapy would mark a significant milestone in PTSD treatment options. “The Phase 3 confirmatory results support the development of MDMA-assisted therapy as a potentially new breakthrough therapy to treat individuals with PTSD—a patient population that is often left to suffer for years,” CEO of MAPS PBC Amy Emerson said in a statement. Although there is still more work to be done in terms of understanding the long-term effects of MDMA, the preliminary findings of the study offer the potential of a life-changing treatment option for those with treatment-resistant PTSD.

References

1. Disorder, Committee on the Assessment of Ongoing Efforts in the Treatment of Posttraumatic Stress, Board on the Health of Select Populations, and Institute of Medicine. 2014. Diagnosis, Course, and Prevalence of PTSD. Www.ncbi.nlm.nih.gov. National Academies Press (US). https://www.ncbi.nlm.nih.gov/books/NBK224874/#:~:text=It%20has%20been%20suggested%20that.
2. Pérez Benítez, Carlos I., Caron Zlotnick, Robert I. Stout, Fengjuan Lou, Ingrid Dyck, Risa Weisberg, and Martin Keller. 2012. “A 5-Year Longitudinal Study of Posttraumatic Stress Disorder in Primary Care Patients.” Psychopathology 45 (5): 286–93. https://doi.org/10.1159/000331595.
3. Mitchell, Jennifer M., Michael Bogenschutz, Alia Lilienstein, Charlotte Harrison, Sarah Kleiman, Kelly Parker-Guilbert, Marcela Ot’alora G., et al. 2021. “MDMA-Assisted Therapy for Severe PTSD: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study.” Nature Medicine 27 (6): 1025–33. https://doi.org/10.1038/s41591-021-01336-3.