There’s No Magic Pill for PTSD – but Here’s What Actually Works.

By Drs. Sofia Noori and Isobel Rosenthal

MDMA-assisted therapy (MDMA-AT) has made headlines across the U.S. in recent months as the FDA ultimately rejected it as a treatment for post-traumatic stress disorder (PTSD), requesting more data in the form of a new phase 3 study. Skeptics of the treatment pointed to concerns around safety, while supporters touted its potential as a breakthrough treatment for PTSD.  As those in favor were quick to point out, the FDA hasn’t approved a new medication for PTSD in 24 years. 

But what’s often lost in this debate is the question of whether any medication, MDMA or otherwise, is really the first place we should look to for treating PTSD. Media coverage surrounding PTSD often conflates the lack of new FDA-approved medications with the field experiencing a dearth of treatment options. In reality, research shows that several psychotherapeutic approaches, including Cognitive Processing Therapy (CPT), EMDR, and Prolonged Exposure (PE) boast the strongest clinical outcomes. And promising new therapies, like Written Exposure Therapy (WET), are being developed. 

Before we lament that the 24-year dry spell in new PTSD medication will continue, it’s important to take a step back and examine whether we even need a pharmacological “magic pill.”

Medications Aren’t The First Line Treatment for PTSD Anyway – Here’s Why 

Medication is not recommended in the clinical literature as a first-line treatment for PTSD. The reality is that survivors can achieve long-term recovery through effective therapies like CPT and PE without requiring medication at all.

Medications such as sertraline, paroxetine, and venlafaxine can improve PTSD symptoms, but are not known to lead to permanent remission, while first-line therapies like CPT and PE lead to improvements that remain durable for up to 10 years or more. Medications may improve the responses to trauma therapy, and are often recommended to complement therapy, but are not sufficient treatment on their own. This is likely why the parent company of MDMA-assisted psychotherapy paired the MDMA with a therapy. 

Existing Treatments Work Just As Well (Or Better) Than MDMA

Despite the media narratives touting MDMA-AT as a breakthrough for PTSD, the outcomes data is simply lacking. The FDA advisory panel that voted to reject MDMA-AT pointed to this (lack of) data when it requested a new phase 3 study. The journal Psychopharmacology just retracted 3 MDMA-related papers due to ethics violations. While there are a number of concerns about the quality of the studies, even if the data were correct, MDMA-AT is only more effective when compared to medications, not the most effective treatments. 

When MDMA-AT data is compared to PTSD psychotherapies, the research does not show better effects.  Researchers often consider the concept of effect size – the higher the effect size, the better. The effect size of MDMA-assisted psychotherapy is the same as the effect size of CPT and PE, and it is much more time-intensive and poses safety risks to the patient. The MDMA-AT protocol takes about 42 hours of therapy with sessions that last 6-8 hours each time, while current therapies take 10-15 hours in total. MDMA can also cause cardiovascular risk in patients. 

Most concerningly, the MDMA-AT therapy protocol involves “bodywork” and touching between the therapist and patient, which poses an unacceptable potential safety risk to already victimized trauma survivors who have endured the unthinkable. MDMA-AT is not more effective than current treatments - it’s just a different approach that has good PR. Given its risks and higher time requirements, its application is likely limited to patients who do not respond to existing PTSD treatments. 

Actually, there have been many exciting breakthroughs in PTSD in recent years. 

Although no new medications have been approved, there are plenty of new psychotherapies that have shown great promise. Written exposure therapy, a new protocol that takes just 5 sessions to complete, has strong emerging data for PTSD. Therapy augmentation with virtual and augmented reality has also shown to be helpful in exposure therapies. Intensive therapy, defined as completing trauma therapy at least 3 times per week, produces recovery faster and may actually be the most effective treatment for PTSD yet. 

There’s no question that there is a dire lack of access to PTSD treatment. In the United States, just 26.8% of our country’s need for mental health professionals is currently met, without accounting specifically for trauma & PTSD specialists. This scarcity is compounded by countless other barriers: lack of insurance coverage, financial inaccessibility, and stigma. But that legitimate need is not a reason to fast-track a solution that lacks clear support from clinical data– or to ignore existing solutions that do work. 

The allure of MDMA as a “cure all” for PTSD is easy to understand, but if we frame MDMA as the holy grail of PTSD treatment, other innovations in the field are at risk of being discounted. We also fear that the media’s focus on MDMA-AT will prompt survivors to “wait” for MDMA, when effective treatments exist that can help them recover now, not later. If we ignore strong treatments because they don’t have that shiny-new-thing cachet of psychedelic therapy, then we risk worsening the treatment gap for PTSD and building misinformation amongst survivors who deserve the best, most enduring help we can give them. 

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