A therapy using the drug MDMA to treat post-traumatic stress disorder (PTSD) is likely to be approved by the US Food and Drug Administration (FDA) within the next year. This follows the successful completion of the largest clinical trial to date, which demonstrated the safety and effectiveness of the treatment in a diverse group of participants.
PTSD, which affects an estimated 3.9% of people worldwide at some point in their lives, is currently treated with antidepressants. However, these drugs only lessen the symptoms and do not address the underlying cause of the condition.
Preliminary studies have shown that MDMA, commonly known as ecstasy, could be used in psychotherapy to help individuals with PTSD. The drug induces a relaxed and trusting state and reduces fearful responses when recalling past trauma, enabling patients to engage more openly with therapists.
The recent clinical trial involved 104 people diagnosed with moderate to severe PTSD in the US and Israel, including individuals from diverse ethnic backgrounds. The participants received three therapy sessions over the course of a month, with half of the group receiving MDMA and the other half receiving a placebo. The results showed that 71.2% of the MDMA group no longer met the diagnostic criteria for PTSD, compared to 47.6% in the placebo group.
In 2017, the FDA granted MDMA-assisted psychotherapy a “breakthrough therapy” designation, which allowed for the design of clinical trials to meet the necessary evidence for approval. As a result, the treatment is expected to receive FDA approval early next year.
Experts are optimistic about the potential benefits of MDMA therapy for PTSD. However, further research is needed to determine the long-term effects of the treatment and its durability.
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