Sehrish Sayani, a marketing executive in Los Angeles, suffered from post-traumatic stress disorder following her mother’s sudden death. She experienced intense panic attacks, hypervigilance, hairpin triggers, and fitful sleep. After learning about psychedelic therapy with MDMA, she joined a clinical trial and underwent three in-office sessions with the drug and intensive psychotherapy, which she qualified for after initially being given a placebo. This trial would have been unimaginable a decade ago when possessing psychedelic drugs would lead to severe criminal penalties under the U.S. Drug Enforcement Administration’s classification as Schedule 1 substances, pertaining to drugs with “no currently accepted medical use and a high potential for abuse.” However, Lykos Therapeutics (formerly MAPS Public Benefit Corporation) has submitted the first psychedelic in decades to the U.S. Food and Drug Administration for evaluation as a treatment for PTSD. With the potential approval of either MDMA or a synthetic form of psilocybin, the reclassification of psychedelics by the DEA and the possibility of prescribing psychedelic-assisted psychotherapy by doctors could become a reality. During the clinical trial, Sayani initially felt marginally better but experienced no significant changes. She later received three more sessions with the actual drug and the transformation she experienced was profound. She now feels happy, sleeps well, and is no longer prone to anxiety. This has led her to advocate for the potential benefits of the drug for others suffering from PTSD.
The prospect of psychedelic-assisted therapy is generating excitement among medical experts due to the millions of Americans with mental illnesses who have not found relief with traditional therapies. Some believe that the current mental health tools are insufficient and that psychedelics could be a game-changer. The FDA is expected to rule on Lykos’s application for MDMA therapy based on two large-scale clinical trials that demonstrated a significant improvement in PTSD symptoms with three sessions of MDMA-assisted therapy. The potential side effects and the complex nature of drug approvals however, highlight the challenges associated with this process.
If the FDA approves MDMA therapy, it may be used for other conditions as well, such as eating disorders, social anxiety in people with autism, and the distress of having a terminal diagnosis. Additional studies have shown potential benefits of psilocybin for major depression, anxiety, and alcohol use disorder. The advocacy for the use of psychedelics is gaining momentum, with some states taking matters into their own hands by legalizing and regulating psychedelics such as psilocybin-mushroom therapy. People in Oregon have had access to psychedelic therapy since 2023, and a similar program is expected in Colorado. Several cities have also decriminalized possession of psychedelics for personal use, despite the potential for federal prosecution due to DEA prohibitions. Some countries, such as Canada and Australia, have also taken steps to legalize or prescribe psychedelics for mental-health conditions.
Despite the potential benefits, concerns have been raised about the cost of therapy, as the intensive nature of psychedelic therapy sessions could translate to high prices for consumers unless insurance covers the cost. The need for intensive psychotherapy along with the drug, while adding to the cost, has been seen as a valuable aspect of psychedelic therapy by some experts, as it integrates medical and psychological care in a unique way.
