The Promise of MDMA-Assisted Therapy for Healing Trauma

MDMA-assisted psychotherapy is safe and effective. Why did the FDA reject it?

Reviewed by Devon Frye

Key points

• MDMA-assisted psychotherapy is a safe and effective treatment for PTSD and complex trauma.
• MDMA-assisted psychotherapy has a much lower dropout rate than other trauma-focused therapies.
• The FDA's recent rejection of MDMA-assisted therapy appears based on conceptual confusion and hypocrisy.
• There's a great need for effective and tolerable trauma treatments. MDMA-assisted therapy holds great promise.

There’s been a lot of news recently about the use of MDMA, sometimes known as ecstasy or molly, combined with psychotherapy, as a novel treatment for trauma. Partly, the news has been good. Really good, in fact. MDMA-assisted psychotherapy (MAP) for trauma has been studied by a top-notch group of researchers at several leading universities, and the results have been impressive.

• Three sessions of MAP, combined with preparatory and integration sessions, led to 71 percent of study participants no longer meeting diagnostic criteria for PTSD. Eighty-six percent of participants reported a meaningful reduction of trauma symptoms. Many of these improvements have been shown to persist a year later.
• MAP has a demonstrated a powerful impact on core symptoms of complex trauma that are often untouched by conventional trauma therapies. This includes changes in what we call self-management or self-experience: emotion regulation, self-compassion, abandonment fears, and identity impairment.
• In the most recent trial of MAP, the dropout rate was 1.9 percent. Compare that to dropout rates in a recent study comparing two popular PTSD treatments, prolonged exposure (PE) and cognitive processing therapy (CPT), in which dropout rates during the study were 56 percent and 46 percent, respectively.

The bottom line: MAP is generating a lot of excitement because it has shown great promise as an effective and acceptable treatment of both adult-onset PTSD and complex PTSD stemming from prolonged childhood trauma.

The bad news? The U.S. Food and Drug Administration recently rejected an application to legalize the use of MAP. Although there were certainly flaws in the design and conduct of the two major trials that were conducted to demonstrate the safety and efficacy of the treatment (see a discussion of these here), the disappointing decision seems to me to have been based on some conceptually flawed and frankly hypocritical grounds. Although the FDA’s rejection letter has not been made public, what we know so far is troubling.

There seems to be serious concern about the confounding role of psychotherapy in the use of MDMA. Essentially, the FDA is asking how we can know the true effects of MDMA if it’s being administered together with psychotherapy. Some experts are concluding that the only way to address this concern is by giving MDMA alone, hoping it will show a similarly large effect on trauma.

But that’s simply not the way MDMA works. It’s not a magic pill that dissolves or eradicates trauma-related memories and feelings. Instead, it turns down the fear response by quieting the amygdala, our brain’s alarm center. In the language of internal family systems or “parts” therapy, it allows our self-protective parts to relax, so that—with the help of therapists—trauma survivors can safely face whatever they have been so terrified of experiencing without becoming overwhelmed.

And because MDMA boosts self-compassion, it allows people to shift their experience of shame and self-rejection to one of self-compassion, forgiveness, and self-acceptance. Using IFS language again, it allows for the nurturing and reintegration of exiled parts who carry pain, shame, and despair.

To have to demonstrate some magical property of MDMA on trauma in the absence of psychotherapy is to fundamentally misunderstand the way MDMA works in the healing of trauma. It facilitates trauma recovery by allowing, in a safe and supporting therapeutic context, the same sort of exposure as other trauma treatments, but without the intense fear that exposure-based treatments often entail, and that may account for their high drop-out rates. In the language of the exciting field of memory reconsolidation, MAP greatly facilitates the modification of deeply rooted trauma-based memories and learnings about oneself and the world—memories and learnings that seem to underlie the persistence of complex trauma symptoms.

There are other flaws in the FDA’s reasoning, to the extent it can be inferred based on the recommendations on which it was based. These include a lack of adequate safety and addictiveness data; however, the FDA approved the highly addictive benzodiazepines for anxiety and the comparably addictive sedative-hypnotics for insomnia; it also approved the devastatingly addictive Oxycontin and other opioids for pain management.

Meanwhile, the safety profile for MAP is actually impressive, with few significant side effects and a much stronger safety profile than numerous other FDA-approved psychiatric medications. For example, many anti-psychotic meds can produce horrible involuntary movements and tics that persist even after the meds are discontinued. Others cause extreme weight gain and significantly increase the risk of diabetes and even death.

There was also concern that participants in the MAP research were not truly blind to their condition (i.e., they accurately guessed that they were on MDMA and not a placebo). If people knew they’d been given MDMA, that might have led them to expect improvement, which in turn could have led to an expectation-driven improvement.

However, the simple reality is that some medications make true blinding impossible. The FDA has approved ketamine for use with treatment-resistant depression, yet ketamine leads to a powerful and highly noticeable psychedelic experience; if you take ketamine, you’re very likely know you’ve taken ketamine and not a placebo (the data on this are similar to that for MDMA).

Moreover, there is compelling evidence that much of the benefit from anti-depressant medications for mild to moderate depression is in fact a placebo effect, rather than having anything to do with the actual chemistry of the medication. This is not to trivialize concerns about placebo effects, but to question why MDMA is being held to a different standard than other medications, especially given its efficacy data and the dearth of effective and acceptable trauma treatments.

The Bottom Line

• Conventional trauma therapies are moderately effective at treating PTSD among those who complete them. That’s promising, but given the high dropout rates, it’s clear that many people are not being helped by such therapies.
• Moreover, conventional PTSD therapies have a limited impact on the self-experience symptoms of complex trauma—the painful experiences stemming early abuse and neglect such as shame, emotional dysregulation, and interpersonal trust.
• Current psychiatric medications only control the symptoms of PTSD, they don’t actually cure trauma. And they are consistently less effective at symptom reduction than trauma-focused psychotherapies.

Against this backdrop, the rejection of MAP—an effective and innovative approach to trauma treatment—is both deeply disappointing and quite puzzling. Perhaps it reflects a remnant of the moralizing and irrational fear that drove the so-called “war on drugs” which began under U.S. President Nixon decades ago. That’s just a speculation; what we know with certainty is that access to a highly promising and much-needed treatment for trauma has been denied and its future left uncertain.