LSD, MDMA, Magic Mushrooms Clinical Trial Guidelines Released by FDA

additudemag.com:

July 7, 2023The Food and Drug Administration (FDA) has issued its first-ever draft guidance for clinical trials of psychedelic drugs to treat conditions including depression, mood disorders, anxiety, post-traumatic stress disorder, and substance use disorder.The guidance aims to address the unique challenges inherent in testing “classic psychedelics,” such as psilocybin (magic mushrooms) and lysergic acid diethylamide (LSD), and “entactogens” or “empathogens,” such as methylenedioxymethamphetamine (MDMA) for treating psychiatric conditions that failed to respond to other therapies.

The FDA recommends clinical trial considerations regarding subject safety, data collection, manufacturing controls, and drug application requirements.Ultimately, “the goal is to help researchers design studies that will yield interpretable results that will be capable of supporting future drug applications,” said Tiffany Farchione, M.D., director of the Division of Psychiatry in the FDA’s Center for Drug Evaluation and Research, in a statement last month.In February 2022, researchers from Johns Hopkins Medicine reported that psilocybin-assisted therapy for major depressive disorder produced antidepressant effects up to 12 months after treatment.1Ari Tuckman, Psy.D., and Stephanie Sarkis, Ph.D., recently told ADDitude that using very low (micro) doses of psychedelics, such as LSD and psilocybin is gaining renewed attention as a treatment for anxiety and depression. “A clinical trial is underway in Europe using a randomized, double-blind, placebo-controlled design, the gold standard for medication research,” they said. “Results are expected in late 2023 and will offer much more helpful conclusions.