LSD, MDMA, Magic Mushrooms Clinical Trial Guidelines Released by FDA
The FDA’s new guidance addresses the challenges of testing psychedelics, such as psilocybin (magic mushrooms), lysergic acid diethylamide (LSD), and methylenedioxymethamphetamine (MDMA) for treating psychiatric conditions.
July 7, 2023
The Food and Drug Administration (FDA) has issued its first-ever draft guidance for clinical trials of psychedelic drugs to treat conditions including depression, mood disorders, anxiety, post-traumatic stress disorder, and substance use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.1
Ari 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. The use of psychedelics over an extended period would also need to be studied for ongoing effectiveness (assuming short-term effectiveness is found) and safety.”
On July 1, 2023, Australia became the first country to legalize psychedelics to treat some mental health conditions. Approved psychiatrists can now prescribe MDMA for PTSD treatment and psilocybin for treatment-resistant depression, respectively, according to Therapeutic Goods Administration (TGA) Australia’s drug regulator.
Source
1Gukasyan, N., Davis, A.K., Barrett, F.S., et al. Efficacy and safety of psilocybin-assisted treatment for major depressive disorder: Prospective 12-month follow-up. Journal of Psychopharmacology. 2022;36(2):151-158. https://doi.org/10.1177/02698811211073759
