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Tag: PTSD

  • FDA won’t approve MDMA for treatment of PTSD

    FDA won’t approve MDMA for treatment of PTSD

    The FDA isn’t approving MDMA (sometimes known as the party-drug ecstasy or molly) for the treatment of post-traumatic stress disorder or PTSD, a mental illness. Some Republican and Democratic members of Congress on the Congressional Psychedelics Advancing Therapies (PATH) Caucus believe the FDA made a mistake. In their view, MDMA could save lives.

    In particular, many think that veterans with PTSD would be well served through MDMA. Other treatments often do not work. Veterans very much supported FDA approval of the psychedelic drug. And, there is mounting support from the public for FDA approval of MDMA. Thirteen million Americans suffer from PTSD.

    The FDA did not rule out future approval of MDMA. Rather, it requested that Lykos Therapeutics, which conducted the clinical trial, conduct a third phase 3 trial to investigate further the safety and efficacy of MDMA. The first two trials suggested MDMA was effective for treating PTSD, but the FDA’s advisory committee claimed that data on adverse events were missing and that the research was biased. A third trial will take several years to complete.

    Olivia Goldhill reports for Stat News that the Institute for Clinical and Economic Review (ICER) determined back in March that evidence supporting MDMA therapy for PTSD was “insufficient.” It posited that there could have been clinical trial misconduct. Trial participants told ICER researchers about “severe negative outcomes.” These outcomes were not reported in the trial data.

    Haleema Shah reports for Vox that MDMA was created decades ago now in a home laboratory, and since then, people have used it illegally. People who use it say that it fills them with love and empathy. Some say that people with PTSD who use it for 18 weeks are relieved of symptoms that other medicines and talk therapy cannot accomplish.

    That said, there is evidence that MDMA can have serious health consequences, including rapid heart rate and other heart conditions.

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  • The value of psychedelics

    The value of psychedelics

    More people have been turning to psychedelics to treat post traumatic stress disorder, depression and addiction. Mattha Busby reports for The Guardian on the value of psychedelics, including magic mushrooms and MDMA.

    Under the supervision of a psychiatrist, psychedelics have been found to help people cope with nightmarish memories. Psychedelics sometimes can lead to behavioral adaptations. One trial showed that people who took MDMA under the care of a psychiatrist were more than twice as likely to treat their PTSD as people who took a placebo.

    Today, there is no medicinal treatment for PTSD that works, so the value of MDMA could be huge. The FDA might approve it to treat PTSD in 2023 or sooner. It might also approve psilocybin, which is in magic mushrooms. One tiny study found psilocybin to work four times better than standard antidepressants.

    There was a time when lawmakers dismissed psychedelic drugs as having no medical benefits, even though there was no evidence behind their thinking. In their view, psychedelics were dangerous, so they kept research on these drugs to a minimum.

    Even former Texas governor Rick Perry now believes that psychedelics can help veterans who suffer from PTSD. Recently, Texas passed a state law to research the value of psychedelics. Oregon lawmakers have already approved legalization of the possession of drugs for personal use. Oregon has also licensed psilocybin therapy. Now, the state is licensing magic-mushroom companies. In Colorado, emergency first responders are being trained in psychedelic harm reduction.

    People at risk of psychological issues seem to see great benefits from psychedelics in clinical trials. One study published in Lancet showed that people who received a high dose of psilocybin saw their depression abate and their anxiety improve for a substantial amount of time. Psilocybin apparently lets the brain be rewired, helping people let go of old beliefs and memories and allowing them to better handle their emotions.

    One other benefit of psychedelics is that it ties people to nature, changing people’s attitudes and behaviors in ways that show greater concern for nature. They might eat differently. They might garden more. They might engage in environmental activism.

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