A new age for psychedelics We are on the verge of a psychedelic renaissance, with the Food and Drug Administration (FDA) accepting a new drug application for midmafetamine (MDMA) in February of this year. MDMA the active ingredient in the common party drug “ecstasy” or “molly”. If approved, the drug would be used to treat
As most people know by now, ketamine clinics are prevalent in the United States. These clinics offer ketamine as a treatment for a variety of disorders, including pain relief, behavioral health disorders, opiate addiction, and many other ailments. Unfortunately, there are not many studies that demonstrate whether ketamine is efficacious for these various ailments because,
On February 16, 2022 and October 10, 2023, the FDA issued two warnings about the use of compounded ketamine. The first warning is entitled, “FDA alerts health care professionals of potential risks associated with compounded ketamine nasal spray,” and the second warning is entitled, “FDA warns patients and health care providers about potential risks associated
A handful of entities are in various stages of the FDA approval process for MDMA and psilocybin drugs (see here and here for some of our prior analysis of the issues). FDA approval could happen in the next few years. But there’s a catch: psilocybin and MDMA are both schedule I drugs under the Controlled Substances Act (CSA).
There are lots of psychedelics and psychedelic adjacent substances that are not scheduled under the Controlled Substances Act (CSA). Recently I wrote about amanita muscaria mushrooms and their legal status. Today, I want to talk about a different one: salvia divinorum. Salvia divinorum Salvia divinorum is a psychedelic substance. It was often used for religious
DMT, or N, N-dimethyltryptamine is a powerful psychedelic. DMT, like its sister psychedelics (LSD, MDMA, psilocybin … and even marijuana), is a Schedule I controlled substance. So according to the DEA, its abuse potential is high and it has no medical use. Also, according to the DEA, “the history of human experience probably goes back
Something strange happened yesterday. Psychedelics unicorn Compass Pathways released data for the largest clinical trial ever conducted of a psilocybin drug. Not only did the drug seem to work, but the heavily anticipated data were “breathtaking” in the words of Compass’ CEO. Immediately, the company’s publicly traded shares dropped 16%. Including the day prior, it
Public and scientific interest in psychedelics such as psilocybin and MDMA is expanding. Once off-limits because of federal prohibition, a trickle of research from the 1990s has grown into a stream. But despite increasing acceptance by the public, and commercial investment in psychedelic therapies, aging federal laws stem the flow of vital research. Psilocybin, a
Excitement abounds about the status of MDMA, otherwise known as Ecstasy. And for good reason. As noted last month in the New York Times: …those who received MDMA during therapy [in clinical trials] experienced a significantly greater reduction in the severity of their symptoms compared with those who received therapy and an inactive placebo. Two
A common question that arises in Ketamine clinic transactions is whether a clinic or physician (collectively, “healthcare providers” or “providers”) can use or promote Ketamine for off-label uses. The short answer is yes, subject to several caveats, as discussed below. However, before reaching the answer, it is important to define what “off-label” use means and
