This week, the U.S. Food and Drug Administration (FDA) rejected the use of the psychedelic drug MDMA to treat post-traumatic stress disorder (PTSD), saying more and better research is needed.
Some supporters of MDMA-assisted therapy have expressed disappointment at the decision, which means there will be a delay of several years before the drug can be given to patients outside of an experimental setting with strict inclusion criteria, intensive monitoring and experimental procedures that significantly limit the number of patients eligible for the treatment.
Having spent years treating and researching trauma in hard-to-treat populations, I can understand this frustration with the lack of effective treatment options for those who are not helped by conventional therapies. This is what motivated us at Metiv, the Israeli Psychotrauma Center, to begin a research study on MDMA-assisted therapies for Israeli war veterans, a group that is notoriously difficult to treat and suffers from severe symptoms of post-traumatic stress disorder that keep them mentally trapped on the battlefield and make it difficult for them to return to civilian life.
But the FDA’s decision only strengthens my belief that patients have a right to know that their treatments have been proven to be effective.
At Metiv, we are conducting one of the few Israeli research studies on the use of MDMA to treat veterans with PTSD. Our study, which began in March 2024 after two years of full-time development, was shaped by the same concerns raised by the FDA about gaps in existing research.
Deficiencies in the study
One major flaw the FDA cited was that trial participants typically found out whether they had received MDMA or a placebo. Knowing they had received the drug may have led participants to believe it would help them. They also pointed out that clinical trial participants received various forms of psychotherapy, the role of which in the outcomes was not specifically measured.
Instead of a placebo, Metiv’s study offers some participants intensive therapy similar to that received by participants receiving MDMA, supplemented with elements from therapies tested at Metiv, including Somatic Experiencing and ACT (Acceptance and Commitment Therapy). This “everything but the drug” approach allows for a direct comparison while still offering participants the benefit of intensive, innovative treatment.
After October 7, the need to care for traumatized soldiers and other members of Israeli society is acute. Millions of dollars have been donated to emergency mental health care in Israel, and there has been a rapid proliferation of new initiatives attempting to meet this need.
This makes it particularly difficult to wait for the results of further research before offering MDMA-assisted treatment to large groups of veterans. However, neither the magnitude of the need nor the actual potential of MDMA-assisted treatment should obscure the basic principle of health care: treatments should be safe, effective and proven.
MDMA is not a complete solution
While we are excited about the potential of new treatment options for veterans with PTSD and the broader Israeli population, we are by no means advocating MDMA as a panacea and are approaching research with a willingness to explore the potentially positive and negative effects of these intensive treatments both with and without MDMA. We have seen very promising results so far from MDMA-treated participants in Israel, but we are also aware of the burden of treatment, both economically and on participants, and are therefore eager to explore both the suitability of treatment and the specific mechanisms of change to find out what works and for whom.
We and our colleagues, particularly those at the Multidisciplinary Association for Psychedelic Studies (MAPS Israel) who provide much-needed advice, care and support, are determined to provide the best care possible to those who need it, even if it takes a little more time.
The author is the director of research at Metiv, the Israel Psychotrauma Center. Metiv, a branch of Herzog Hospital in Jerusalem, conducts research to develop evidence-based methods for treating trauma and offers therapies for adults and children, programs to build individual and community resilience to trauma, and training in trauma treatment for mental health professionals.
