A groundbreaking study has demonstrated that MDMA-assisted therapy can decrease post-traumatic stress disorder (PTSD) symptoms across a diverse cohort of individuals. Based on this evidence, there is mounting anticipation for the substance to receive FDA approval, possibly within the upcoming year.
MDMA, also known as ecstasy or molly, has been shown potential therapeutic benefits since the 1970s, but the FDA made it illegal in the 1980s.
This article discusses the new study showcasing the benefits of MDMA, as well as the treatment's history and future.
Current PTSD Treatment Options
Post-Traumatic Stress Disorder is a debilitating mental health condition triggered by experiencing or witnessing a traumatic event, from natural disasters to serious accidents, military combat, and personal assaults.
Individuals with PTSD often re-experience these traumas through flashbacks or nightmares, making daily life challenging and sometimes unbearable.
Traditionally, the primary treatments for PTSD have centered on psychotherapy and medication.
Cognitive Behavioral Therapy (CBT), specifically trauma-focused CBT, involves gradually and safely recalling the traumatic event and processing the associated emotions.
Eye Movement Desensitization and Reprocessing (EMDR) is another therapeutic process that helps patients process trauma by guiding their eye movements as they confront the event's memories.
Medication-wise, selective serotonin reuptake inhibitors (SSRIs) like paroxetine and sertraline have been FDA-approved to treat PTSD. The condition has been correlated with abnormal regulation of neurotransmitters that modulate stress and fear responses, such as catecholamine, serotonin, amino acid, peptide, and opioid neurotransmitters.
Antidepressants aim to rebalance these levels of neurotransmitters, thus potentially mitigating some of the disorder's symptoms.
However, studies show that psychotherapy may only reduce PTSD symptoms for 21 to 46% of participants. Medications may alleviate PTSD in 54 to 62% of cases. That is why MDMA is investigated as a more effective way to treat this condition.
A Pioneering Study With Diverse Participants
This phase 3 clinical trial, the largest of its kind, was orchestrated by the Multidisciplinary Association for Psychedelic Studies (MAPS). The study encompassed 104 participants spanning the United States and Israel, all diagnosed with moderate to severe PTSD.
The causes of the participants' PTSD included diverse experiences, from childhood trauma and sexual assault to combat-related PTSD. Notably, many had a long-standing history of PTSD, averaging 16 years, coupled with unsuccessful past treatments.
Ensuring diversity, 27% of participants identified as Hispanic or Latino, and 34% as non-white, making it reflective of the broader PTSD-affected population. Dr. Jennifer Mitchell, a neuroscientist from the University of California San Francisco, led this study and took significant steps to ensure the inclusivity of participants. Most importantly, the research offered logistical support like transportation and wage compensation.
Promising Results Highlight Potential of MDMA
The research, recently published in Nature Medicine, detailed a protocol where participants underwent three preparatory talk therapy sessions. Subsequently, they received three treatment sessions wherein they were administered either MDMA or a placebo. Remarkably, 86.5% of those treated with MDMA reported diminished symptom severity, with 71% no longer fitting the PTSD diagnostic criteria. In contrast, 69% of placebo recipients showed improvement, with 48% no longer meeting PTSD criteria.
The treatment was generally well-received, although participants experienced minor side effects such as muscle tension and nausea. However, seven individuals reported cardiovascular concerns, emphasizing the need for careful consideration in older patients.
These outcomes resonate with MAPS' earlier findings, wherein a 2021 study reported that 67% of MDMA recipients no longer fit the PTSD criteria, compared to 32% in the placebo group.
MDMA's History and Its Potential Future
Historically, MDMA's therapeutic exploration was halted in the 1980s when it was categorized as a Schedule 1 drug in the U.S., a classification for substances with high abuse potential and no accepted medical application. Rick Doblin, the founder of MAPS, underscored the missed therapeutic potential of MDMA during this period.
However, in a notable shift, the FDA designated MDMA as a breakthrough therapy in 2017. MAPS has gathered comprehensive data from 18 MDMA trials, so it will submit a New Drug Application to the FDA. MDMA may be approved as early as next year if the petition is successful.
For this approval, the DEA would need to reclassify MDMA. Given recent leniency towards psychedelic substances and anticipated rescheduling of cannabis, a similar move for MDMA seems plausible.
Challenges Ahead for Widespread Adoption
Following in the footsteps of Australia, which has sanctioned the therapeutic use of MDMA for PTSD, the U.S. is contemplating its stance. However, the details of this therapeutic application remain uncertain, mainly because the FDA has yet to establish potential restrictions.
Amy Emerson, CEO of MAPS Public Benefit Corporation (PBC), highlighted the unprecedented nature of drug-assisted therapy approvals. One obstacle is that medical professionals require specialized training to implement this procedure, but MAPS is actively addressing this issue.
Simultaneously, discussions with insurance providers are underway to ensure broader accessibility.
MAPS continues its research by undergoing investigations on MDMA-assisted therapy's long-term benefits. Previous studies indicate that potential benefits last up to a year, but Dr. Mitchell emphasized the importance of verifying these prolonged effects in the current phase of research.
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