This week, the Drug Enforcement Administration (DEA) proposed increases to the production quotas of psilocybin, psilocin, and ibogaine for use by researchers investigating therapies with psychedelic compounds. The DEA oversees the regulated synthesis and cultivation of restricted psychoactive materials for scientific investigations.

A revised production agenda for 2024 calls for psilocybin and psilocin production to be increased by 50% – from 20,000 to 30,000 grams for psilocybin, and 24,000 to 36,000 grams for psilocin. These are the gram amounts planned for 2025 as well.

The DEA’s plans for 2025, posted as a notice in the Federal Register, includes the increased manufacturing of ibogaine from 150 to 210 grams. There is no change to the manufacturing level of other psychedelics such as MDMA or 5-MeO-DMT.

“This opens the door to more research, more clinical trials, and a better understanding of how we can apply emerging therapies,” says Representative Morgan Luttrell (R-TX). Luttrell is a former Navy SEAL whose therapeutic experiences with ibogaine and 5-MeO-DMT inform his advocacy for the government to fund psychedelic research, including allocations made in the fiscal 2024 National Defense Authorization Act. 

Expanding Research

The Controlled Substances Act, signed into law in 1970 by Richard Nixon, created five schedules under which to list drugs and allowed governmental regulation of how much of each drug could be produced for any purpose. Many psychedelics were placed under Schedule 1, the most limited schedule.

Researchers studying psychedelics in subsequent years faced scarce supplies of these substances, but their availability in recent years has grown significantly. In 2020 the DEA planned the production of just 30 grams of psilocybin; by 2024, the DEA increased the production to 20,000 grams.

The re-emergence of psychedelics as medicines is supported by expanding interest by researchers to study these compounds for their potential for effective treatments for mental health issues including depression, PTSD, and substance use disorder. Substances like psilocybin, psilocin and ibogaine are still listed in Schedule 1, which declares that they have no currently-accepted medical use. Researchers are investigating new treatments for mental health disorders through a variety of proposed mechanisms – such as by re-opening critical periods of learning or by collapsing default mode network activity in the brain. 

Despite promising areas of research to find new mental health treatments, DEA scheduling has been a major impediment into research on psychedelics, says Dalibor Sames, a professor of chemistry at Columbia University who studies iboga alkaloids. “While we have the DEA license, it is highly inefficient and cumbersome to share scheduled substances with collaborators,” he says. “Research in these days is highly collaborative and thus sharing compounds and other research items is an essential part of doing science and drug discovery today.”

By increasing their production quotas, DEA appears to be signaling their intent to support psychedelic research, stating in the revised 2024 notice: “These proposed increases demonstrate DEA’s support for research with schedule I controlled substances,” writes the agency. “The proposed increases reflect research and development needs as part of the process for seeking the FDA approval of new drug products.”

For researchers like Sames, who uses small amounts of iboga alkaloids in the study of psychedelic chemistry, the new quota has no immediate impact. But the increased availability of these three drugs could influence their availability for use in clinical trials with human subjects. 

Single oral doses of ibogaine of around one gram have been used in clinical trials for opioid use disorder. The common dose of psilocybin in clinical trials is 25mg, or what is found in approximately 2.5g of dried Psilocybe cubensis mushroom.

Under The U.S. Government’s Care

For federally regulated research, the Department of Veterans Affairs (VA) is playing an increasingly prominent role in investigations into psychedelic-assisted therapies.

This year the VA requested proposals to study the effect of MDMA and psilocybin for PTSD and depression in veterans, noting that the “VA and the Biden-Harris Administration are committed to exploring all avenues that promote the health of our nation’s Veterans.” Congress passed $20 million this March for the VA’s use to study MDMA-assisted therapy and psilocybin. 

According to Luttrell, this new increase in production quotas for ibogaine, psilocybin, and psilocin signals that federal regulators are supporting the expansion of psychedelic research. Luttrell says this reflects a growing recognition among federal regulators of the therapeutic potential of these substances.

Alongside the DEA’s new manufacturing increases, this year the FDA added two new ‘Breakthrough Therapy’ designations, given to accelerate the review process for new drugs, to Mindmed’s LSD formulation MM120 and Cybin’s psilocybin analog CYB003. These come in light of other psychedelics given this designation in previous years, including MAPS’s MDMA-assisted therapy, and Usona Institute’s and Compass Pathways’ psilocybin analogs. But the federal agencies have also made efforts to extend limits on psychedelic drugs. 

Last month, the FDA declined to approve MDMA-assisted therapy after an FDA Advisory panel voted 10-1 against the therapy, saying that its benefits do not outweigh its risks. Likewise, the DEA has recently attempted to place other psychedelics such as 2,5-dimethoxy-4-iodoamphetamine (DOI) and 2,5-dimethoxy-4-chloroamphetamine (DOC) into Schedule 1. Facing resistance from the scientific community and psychedelic advocates, the DEA canceled its proposed hearing originally planned for this June.

Luttrell notes that in his view it is important to proceed cautiously with the regulation of psychedelics. He believes these potential treatments may offer veterans and service members a lifeline for new therapies, especially for post-traumatic stress, traumatic brain injuries, and other combat-related damage. But Luttrell says he doesn’t want the re-emergence of psychedelic research to “go off the rails,” disrupting its potential to help those who would benefit from access.

“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.”