US regulators are likely to approve MDMA-assisted psychotherapy as a treatment for post-traumatic stress disorder (PTSD) in the near future. This follows the successful completion of the largest clinical trial to date, which found that the treatment was safe and effective in a diverse group of participants. Currently, the only approved pharmaceutical drugs for PTSD in the US are antidepressants.
PTSD affects an estimated 3.9% of people worldwide at some point in their lives. While antidepressants target the depression often associated with PTSD, they do not address the underlying cause of the condition. MDMA, also known as ecstasy, has been investigated in numerous studies as a potential therapy for PTSD. The drug induces a relaxed and trusting state, making it easier for individuals to recall past trauma and engage openly with therapists.
The latest study involved 104 people with moderate to severe PTSD in the US and Israel. Half of the participants received MDMA alongside therapy sessions, while the other half received a placebo. After three therapy sessions, 71.2% of the MDMA group no longer met the diagnostic criteria for PTSD, compared to 47.6% of the placebo group.
In 2017, the US Food and Drug Administration (FDA) granted MDMA-assisted psychotherapy a "breakthrough therapy" designation, which allowed for the design of clinical trials to facilitate the approval process. As a result, the treatment could receive FDA approval early next year.
The positive results of this study add to the growing body of evidence supporting the use of MDMA-assisted psychotherapy for PTSD. Australia has already authorized doctors to prescribe MDMA for PTSD alongside psychological support, making it the first country to do so.
While these results are encouraging, further research is needed to confirm the long-term effects of MDMA-assisted therapy and determine its efficacy in different populations. Nevertheless, experts believe that this study brings the treatment closer to clinical use and highlights the potential to save lives and alleviate suffering.
Overall, the findings of this clinical trial provide hope for individuals with PTSD and suggest that MDMA-assisted psychotherapy could be a valuable addition to the treatment options available.