JAMA Psychiatry

Brain Wellness “Spas”— Anticipating the Off-label Promotion of Psychedelics

Psychedelic drugs have reemerged as a promising adjunct to psychotherapy for a variety of mental health indications. Recent phase 3 clinical studies indicate 3,4-methylenedioxymethamphetamine (MDMA) is both efficacious and well tolerated in the treatment of posttraumatic stress disorder.1 Psilocybin—naturally found in mushrooms—appears in phase 2 studies to be efficacious in treating depression. The US Food and Drug Administration (FDA) has designated both as breakthrough therapies, fast-tracking them for approval.2 Commercial interest has surged, with dozens of companies investing in psychedelic drug development in what is predicted to be a multibillion-dollar market.3