This week the US Food and Drug Administration (FDA) rejected the use of the psychedelic drug MDMA to treat post-traumatic stress disorder (PTSD), saying that more and better research would be needed.
Some advocates of MDMA-assisted therapy have expressed disappointment at the decision, which means that there will be a delay of several years until the drug can be administered to patients outside an experimental setting with strict inclusion criteria, intense monitoring, and experimental procedures that significantly limit the number of patients able to attempt the treatment.
Having spent years treating and researching trauma in difficult-to-treat populations, I empathize with this frustration at the lack of effective treatment options for those who are not helped by conventional therapy. This is really what motivated us at Metiv, the Israel Psychotrauma Center, to begin a research study on MDMA-assisted therapy for Israeli military veterans, a group that is notoriously difficult to treat and one that suffers from high levels of Post Traumatic Stress Disorder symptoms that leave them mentally stuck on the battlefield, struggling to return fully to civilian life.
But the FDA’s decision only reinforces my conviction that patients deserve to know that the treatments they receive have been proven to be effective.
At Metiv, we are conducting one of the few Israeli research studies on using MDMA to help treat veterans with PTSD. Our study, which began in March 2024, following two years of full-time development, was shaped by the same concerns that the FDA expressed about gaps in the existing research.
Flaws in the study
One major flaw the FDA cited is that participants in the study usually figured out whether they had been given MDMA or a placebo. Knowing they got the drug may have biased participants to expect it would help them. They also noted that participants in the clinical trials received various forms of psychotherapy whose role wasn’t specifically measured in the results.
Instead of using a placebo, Metiv’s study offers some participants an intensive course of therapy that parallels the therapy offered to the participants receiving MDMA, enhanced with elements from therapies tested at Metiv, including somatic experiencing and ACT (Acceptance and Commitment Therapy). This “everything but the drug” approach allows a side-by-side comparison while still offering participants the benefit of intensive, innovative treatment.
In the aftermath of October 7, the need to care for traumatized soldiers and other members of Israeli society feels acute. Millions of philanthropic dollars have been donated to emergency mental health care in Israel, and there has been a wild growth of new initiatives attempting to meet that need.
In this context, it feels particularly difficult to wait for the results of further research before offering MDMA-assisted treatment to large groups of veterans. But neither the extent of the need nor the real potential that MDMA-assisted treatment holds should obscure the basic principle of healthcare: Treatments should be safe, effective, and proven.
MDMA not a one-stop solution
While we are excited about the potential for new treatment options for veterans with PTSD and the wider Israeli population, we are by no means advocating MDMA as a one-stop solution, and we are approaching the research with a willingness to explore the potentially positive and negative outcomes of these intensive treatments, both with and without MDMA. We have seen very promising results coming from MDMA treated participants in Israel so far but we are also well aware of the burden of the treatment, both economically and for the participants, and thus are eager to research both the suitability of the treatment and also the specific mechanisms of change in order to distill what works and for whom.
We and our colleagues, specifically those at The Multidisciplinary Association for Psychedelic Studies (MAPS Israel), who have been providing much needed advice, supervision and support, are committed to offering the best possible care to people who need it, even if it takes a bit more time.
The writer is director of research at Metiv, the Israel Psychotrauma Center. Metiv, an affiliate of Herzog Hospital in Jerusalem, conducts research to develop evidence-based methods for treating trauma, and offers therapy to adults and children, programs to build individual and community resilience in the face of trauma, and training in trauma treatment to mental-health professionals.