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May 6, 2021

The Results Are In for the Phase 3 Clinical Trial of MDMA-assisted Treatment of PTSD

Dr. John Huber

The long-awaited results from the MAPS-conducted Phase 3 clinical trial of MDMA-assisted treatment of PTSD are finally in. The preliminary, peer-reviewed results arrived on May 3, 2021 and even upon first glance, they represent a landmark achievement in the ongoing research into the application and efficacy of psychedelic-assisted medicine. 

What is MDMA and how can it help with trauma?

MDMA (street names: ecstasy or molly) is a psychoactive chemical empathogen (3,4-Methylenedioxymethamphetamine) that has predominantly been used as a recreational drug and is known for producing temporary euphoric and pro-social effects in those who use it. 

In the last decade, MDMA has been recognized for offering promising therapeutic applications, in conjunction with talk therapy for those struggling with trauma-related disorders. The promise of MDMA stands in contrast to traditional pharmaceuticals, which are touted as instant-fixes to mental health afflictions. Rather, the efficacy of MDMA-assisted treatment relies on utilizing talk therapy while they are under the influence of MDMA to create an avenue for the patient to process traumatic memories. 

The American Psychiatric Association defines PTSD as “a psychiatric disorder that may occur in people who have experienced or witnessed a traumatic event such as a natural disaster, a serious accident, a terrorist act, war/combat, or rape or who have been threatened with death, sexual violence or serious injury.” 

While not everybody who has experienced trauma develops PTSD, diagnosing the condition requires that an individual’s symptoms are prolonged for over one month and must cause a significant interference in their daily life. Approximately 7-8% of the U.S. population will experience PTSD at some point in their life. The number kicks up even higher when you segment out combat veterans with estimates hovering in the 13-14% range. 

Psychiatric care in the form of Cognitive Behavioral Therapy has been the primary vessel of treatment for those with a PTSD diagnosis. As MDMA-assisted psychotherapy picked up steam in the world of medical research, investments in studies and development followed suit. Even the U.S. Food and Drug Administration (FDA) cosigned the MAPS clinical studies, designating it as a Special Protocol Assessment which in essence, allows those conducting the study to utilize MDMA within the patient participants. In 2019, the FDA agreed to an Expanded Access Program for these trials, which will increase the initial study’s participant size and expand into multiple study site locations. 

What are the results and what do they tell us?

For the randomized and blinded Phase 3 Trial of MDMA-Assisted Therapy for PTSD, there were 90 participants who had been suffering from PTSD for an average of 14 years. 

The top-line result was the one that stole the show:

67% of participants who received three MDMA-assisted therapy sessions no longer qualified for a PTSD diagnosis and 88% experienced a clinically meaningful reduction in symptoms. Additionally, 88% showed a clinically meaningful reduction in symptoms.” 

These results mimicked the results of the Phase 2 Trials and by all measures, present a radical shift in how the medical community may approach the treatment of PTSD going forward. Such high rates in treatment response are rare to come by so, as expected, the psychedelic, medical, and tech worlds all took notice after the results went public. 

Ultimately this is a landmark step towards the medical approval of MDMA for the treatment of PTSD. Both popular and political support for these trials has been instrumental in clearing the path towards federal approval, which some expect to come as early as 2023. 

We started Tripsitter Clinic to broaden access to a variety of powerful, life-saving psychedelic therapies. From the get go, we always said that ketamine is just the start. Our team is keeping a close eye on this exciting news, as well as the trials into psilocybin in the treatment of Major Depressive Disorder. Pending legality and safety concerns, our goal is to be able to help broaden access to breakthrough healing modalities through Tripsitter Clinic’s brand of at-home, physician directed psychedelic therapy. 

TripSitter Clinic is transforming lives.

Sources:

Multidisciplinary Association for Psychedelic Studies
https://maps.org/

MAPS’ Phase 3 Trial of MDMA-Assisted Therapy for PTSD Achieves Successful Results for Patients with Severe, Chronic PTSD
https://maps.org/news/media/9122-maps-phase-3-trial-of-mdma-assisted-therapy-for-ptsd-achieves-successful-results-for-patients-with-severe-chronic-ptsd

Will Stone, MDMA, or Ecstasy, Shows Promise as a PTSD Treatment
https://www.scientificamerican.com/article/mdma-or-ecstasy-shows-promise-as-a-ptsd-treatment/

American Psychiatric Association, What Is Posttraumatic Stress Disorder?
https://www.psychiatry.org/patients-families/ptsd/what-is-ptsd

U.S. Department of Veteran Affairs, PTSD: National Center for PTSD
https://www.ptsd.va.gov/understand/common/common_adults.asp#:~:text=About%207%20or%208%20out,have%20gone%20through%20a%20trauma
.

American Psychological Association, Cognitive Behavioral Therapy (CBT)
https://www.apa.org/ptsd-guideline/treatments/cognitive-behavioral-therapy

MAPS, MDMA-Assisted Therapy Study Protocols
https://maps.org/research/mdma


Dr. John Huber
CEO

Dr. Huber is a mental health professional of over 20 years, as well as a clinical forensic psychologist. He regularly provides analysis to national and local media and has appeared on over three hundred radio shows (NBC Radio, CBS, Fox News Radio) and thirty national television programs (ABC, NBC, Spectrum News). In addition, Dr. Huber is also the host of “Mainstream Mental Health Radio” a nationwide broadcast delivering interviews with today’s top mental health professionals.