The Drug Enforcement Administration (DEA) has proposed significant increases in the production quotas for psilocybin, psilocin, and ibogaine, signaling a major boost for clinical research into psychedelic therapies. The revised production agenda for 2024 calls for a 50% increase in psilocybin and psilocin production, from 20,000 to 30,000 grams and 24,000 to 36,000 grams, respectively. These quantities are also planned for 2025.
Increased Manufacturing
The DEA's plans for 2025, include increasing ibogaine manufacturing from 150 to 210 grams. There are no changes to the manufacturing levels of other psychedelics like MDMA or 5-MeO-DMT. Representative Morgan Luttrell (R-TX), a proponent of psychedelic research, stated, "This opens the door to more research, more clinical trials, and a better understanding of how we can apply emerging therapies."
Background on Psychedelic Research
Following the Controlled Substances Act of 1970, many psychedelics were placed under Schedule 1, severely limiting research. In 2020, the DEA planned for only 30 grams of psilocybin production, a stark contrast to the 20,000 grams planned for 2024. The resurgence of interest in psychedelics stems from their potential to treat mental health issues such as depression, PTSD, and substance use disorder. Researchers are exploring mechanisms like re-opening critical learning periods and collapsing default mode network activity in the brain.
Challenges and Opportunities
Dalibor Sames, a professor of chemistry at Columbia University, notes that DEA scheduling has been a major impediment to psychedelic research. "While we have the DEA license, it is highly inefficient and cumbersome to share scheduled substances with collaborators," he says. The DEA's increased production quotas indicate their support for research, stating, "These proposed increases demonstrate DEA’s support for research with schedule I controlled substances… [and] reflect research and development needs as part of the process for seeking the FDA approval of new drug products."
Clinical Applications and Dosage
Single oral doses of ibogaine around one gram have been used in clinical trials for opioid use disorder. The common dose of psilocybin in clinical trials is 25mg, equivalent to approximately 2.5g of dried Psilocybe cubensis mushroom.
Government Support and Future Directions
The Department of Veterans Affairs (VA) is increasingly involved in psychedelic-assisted therapy research. This year, the VA requested proposals to study the effects of MDMA and psilocybin for PTSD and depression in veterans, with Congress allocating $20 million for these studies. Alongside increased manufacturing, the FDA has granted Breakthrough Therapy designations to Mindmed’s LSD formulation MM120 and Cybin’s psilocybin analog CYB003, highlighting the growing recognition of their therapeutic potential.
Cautious Optimism
Despite these advancements, caution remains. The FDA recently declined to approve MDMA-assisted therapy, and the DEA has attempted to place other psychedelics into Schedule 1. Representative Luttrell emphasizes the importance of cautious regulation to ensure these treatments benefit those who need them most, particularly veterans. "We are in the midst of a mental health crisis, particularly among veterans, where we are seeing suicide rates continue to climb," Luttrell writes. "Thinking outside of the box is crucial when the lives of our service members and veterans are at stake."
