DEA Proposes Significant Increase in Production Quota for Research Psilocybin
The U.S. Drug Enforcement Administration (DEA) has proposed a major increase to limits on the production of psilocybin, psilocin and marijuana used for research purposes.
The proposed adjustments, published in the Federal Register yesterday, outline the rationale and changes in quotas. While a number of other Schedule I and II substances are seeing quota changes, including a number of fentanyl-related substances that are now given modest quotas, the most significant proposed quota revisions concern psilocybin, psilocin and marijuana.
At present, the federal quota for psilocybin is set at 30g. Here, the DEA is proposing a change of that quota to 1,500g (1.5kg), a fifty-fold increase. The quota for psilocin (see our psychedelics glossary), meanwhile, is set to shift from 50 grams to 1,000g (1kg).
To understand the implications of these proposed quota increases, let's think about this in terms of doses. Most trials of psilocybin for depressive disorders employ a 25mg dose, including Usona Institute's Phase 2 study of psilocybin for Major Depressive Disorder (MDD).
Using admittedly crude math, one might assume that we can derive (at best) forty 25mg doses from a gram of psilocybin. This means that a federal production quota of 30g supports 1,200 25mg doses, while the new quota would allow for 60,000 doses.
Of course, a large portion of this psilocybin will be used in nonclinical work. Still, if one looks at the range of drug development efforts underway using psilocybin, it's not surprising that many are excited about this proposal.
Not only would the proposed quota increase likely make it at least somewhat easier, and cheaper, to acquire psilocybin for research purposes, many also see it as a positive signal from the Administration, which wrote in its notice: "[the] DEA firmly believes in supporting regulated research of schedule I controlled substances," and noted that the quota increases "are directly related to increased interest by DEA registrants in the use of hallucinogenic controlled substances for research and clinical trial purposes."
LA Times Op-Ed: Doctors Aren't Prepared for Psychedelic Treatments
In an Op-Ed for LA Times, Rick Doblin and Jennifer Ouyang Altman argue that doctors aren't prepared for the increased interest in, and usage of, psychedelics as therapeutics.
It’s not a question of whether people will use powerful psychedelics in pursuit of mental health. They do and they will. Let’s hope patients feel comfortable talking to their healthcare providers about it. When providers face that moment, they should know how to keep patients safe — and they should know better than to stand between ill patients and promising treatments.