The First Phase 3 Success for Psychedelics Will Pave the Way for an Industry (Barron’s):
Post-traumatic stress disorder is a crippling, hard-to-treat psychiatric affliction. America spends billions of dollars yearly just on the veterans who suffer from PTSD. So it’s heartening to see the report of a promising new treatment, published Monday in Nature Medicine.
In Monday’s report, an international team of researchers describe their test of a treatment combining psychotherapy with doses of MDMA—the illegal drug popularly known as Ecstasy or Molly. The MDMA-assisted therapy was dramatically effective at reducing PTSD symptoms and improving daily functioning in the 42 treated participants, when compared with the 37 participants who got psychotherapy and a placebo drug.
Two months after their last drug-assisted session, two-thirds of the MDMA-treated patients no longer met the diagnosis for PTSD, compared with one third of those treated with placebos … The Nature authors speculate that MDMA-assisted sessions produce a “window of tolerance,” in which patients are able to revisit traumatic memories, with less shame and anger, and without being overwhelmed by PTSD symptoms. The treatment worked equally well for patients with histories of drug and alcohol abuse.
MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study (Nature Medicine). From the Abstract:
- Post-traumatic stress disorder (PTSD) presents a major public health problem for which currently available treatments are modestly effective. We report the findings of a randomized, double-blind, placebo-controlled, multi-site phase 3 clinical trial (NCT03537014) to test the efficacy and safety of 3,4‑methylenedioxymethamphetamine (MDMA)-assisted therapy for the treatment of patients with severe PTSD, including those with common comorbidities such as dissociation, depression, a history of alcohol and substance use disorders, and childhood trauma. After psychiatric medication washout, participants (n=90) were randomized 1:1 to receive manualized therapy with MDMA or with placebo, combined with three preparatory and nine integrative therapy sessions … These data indicate that, compared with manualized therapy with inactive placebo, MDMA-assisted therapy is highly efficacious in individuals with severe PTSD, and treatment is safe and well-tolerated, even in those with comorbidities. We conclude that MDMA-assisted therapy represents a potential breakthrough treatment that merits expedited clinical evaluation.
News in Context:
- Study: Psychedelics can promote neural plasticity in the prefrontal cortex and expand pathways for mental health
- Recent book by Michael Pollan: How to Change Your Mind: What the New Science of Psychedelics Teaches Us About Consciousness, Dying, Addiction, Depression, and Transcendence
- Classic book by Aldous Huxley: The Doors of Perception and Heaven and Hell
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