Why It’s Perversely Easier to Research Cocaine Than Psilocybin
Read our recent piece on the dangers of keeping psychedelics restricted:
One of the great ironies of American drug policy is that researchers can face substantially greater obstacles studying psilocybin, the active compound in psychedelic mushrooms, than studying cocaine or methamphetamine.
Dr. Matthew Johnson, a psychiatry professor at the Medical College of Georgia who spent nearly two decades conducting pioneering psychedelic research at Johns Hopkins University, has firsthand experience with all three substances.
“I’ve been a principle investigator on studies with psilocybin and cocaine and methamphetamine,” Johnson told me in our new episode of The Illusion of Consensus. “By far psilocybin is more difficult because it’s the only one out of those three that’s Schedule One.”
Under the Controlled Substances Act, psilocybin is classified as Schedule I, the federal government’s most restrictive category, reserved for substances deemed to have high abuse potential and no currently accepted medical use. Cocaine and methamphetamine, despite their substantially greater addictive potential, are Schedule II because they have accepted medical applications.
The distinction has profound consequences for researchers.
According to Johnson, Schedule I restrictions increase costs, delay clinical trials, constrain pharmaceutical manufacturing, and discourage scientists from exploring new therapeutic applications.
Clinical Trials Can Take Over a Year Just to Get Approved
When I asked Johnson how long it takes to obtain the necessary approvals for a psilocybin clinical trial, his response was startling.
“Sometimes it’s taken over a year once you get the funding to do a study ... to get all of the approvals.”
Even when the process moves relatively quickly, he explained, it can take six months.
Researchers must navigate overlapping approval processes involving the Food and Drug Administration (FDA), Drug Enforcement Administration (DEA), and institutional review boards (IRBs).
Complicating matters further, these organizations sometimes condition their approvals on receiving authorization from one another, producing bureaucratic bottlenecks.
“A lot of these organizations will not approve until the other one approves,” Johnson explained.
The DEA also relies on the FDA for certain scientific reviews, meaning researchers may encounter additional layers of evaluation even after satisfying other FDA requirements.
But the delays extend far beyond paperwork.
The Drug Supply Bottleneck
One of the most consequential effects of Schedule I, Johnson explained, is the limited availability of pharmaceutical-grade psychedelics for research.
Manufacturing Schedule I substances requires specialized licensing and regulatory compliance, restricting the number of companies willing to produce them.
“There’s only a limited number of manufacturers that are willing to create a Schedule One drug because there’s more requirements,” Johnson said.
Consequently, researchers can struggle to obtain the compounds they need, even when their studies have received the necessary government approvals.
Johnson recounted a series of extraordinary experiences illustrating these obstacles.
In one multisite psilocybin trial, a Canadian manufacturer was authorized to supply the drug to American researchers. Although the FDA and DEA had approved the arrangement, New York state authorities would not permit the New York research site to import the compound.
As a result, Johnson’s team had to use different psilocybin products across three research sites, introducing an unnecessary complication into the study.
Johnson acknowledged that he couldn’t be certain whether Schedule I specifically caused the New York restriction, but the incident illustrated the difficulties of navigating overlapping regulatory requirements.
In another instance, a company supplying a research compound essentially went out of business, complicating the ongoing purity testing needed to continue using the substance.
Even university pharmacies sometimes refuse to handle Schedule I drugs because they don’t want to assume the additional regulatory burdens and DEA inspection requirements.
Johnson encountered one institutional pharmacy that declined to handle Schedule I compounds despite already storing other controlled substances.
The irony, he noted, was that universities could handle substantially more addictive drugs, including opioids and stimulants, while refusing to store psilocybin.
How Schedule I Discourages Scientific Innovation
Perhaps the most under-appreciated consequence of Schedule I is that it discourages scientists from investigating psychedelics in the first place.
Johnson offered the example of a sleep researcher interested in exploring whether psychedelic treatments could improve sleep disorders.
Such a scientist may have extensive expertise in sleep medicine and already possess the necessary authorizations to conduct studies involving Schedule III or IV medications.
But investigating psilocybin would require navigating an entirely new regulatory process associated with Schedule I.
Faced with those additional costs, delays, and administrative responsibilities, the researcher might simply abandon the idea.
That has implications well beyond sleep medicine.
Researchers specializing in addiction, depression, neurodegenerative disorders, and other conditions may be discouraged from exploring potential psychedelic treatments, even when they have promising hypotheses.
The same problem affects pharmaceutical innovation.
Johnson argued that moving psilocybin out of Schedule I would make it easier for new companies to enter psychedelic medicine development, particularly during the earliest stages of pharmaceutical research:
“And probably more important than all of that is it’ll encourage new companies to jump into the psychedelic medical development space. It’s gonna be a lot easier for the earlier-phase chemistry.”
Restrictions on novel psychedelic compounds can similarly discourage chemists and pharmaceutical developers from investigating molecules that might eventually yield new treatments.
This means the consequences of Schedule I cannot be measured merely by counting delayed studies. There are also potentially valuable studies that never begin and medicines that may never be developed.
Johnson’s Proposed Solution
Johnson believes the federal government could eliminate one of the field’s largest bottlenecks by establishing a reliable supply of pharmaceutical-grade psychedelics for authorized clinical trials.
He has spent approximately a decade advocating for federal drug-supply programs to manufacture compounds such as psilocybin, MDMA, and LSD.
His proposal would expand government-supported manufacturing to provide researchers with Good Manufacturing Practice (GMP)-grade compounds at little or no cost beyond production expenses.
The National Institute on Drug Abuse already operates a drug-supply program, which Johnson believes could serve as a model.
Researchers with the appropriate FDA authorization should be able to obtain these compounds regardless of whether their studies are funded by the NIH, private foundations, or commercial sponsors.
“I should be able to get it from the government and be like, this is GMP pure psilocybin,” Johnson said.
Such a system would reduce dependence on individual pharmaceutical companies, alleviate manufacturing shortages, and prevent promising studies from being derailed by supply-chain complications.
Reschedule Psilocybin
But the broader solution, Johnson argues, is to reconsider psilocybin’s Schedule I classification itself.
Rescheduling would not eliminate the need for FDA authorization, ethical review, pharmaceutical quality controls, or appropriate security safeguards. Nor would it automatically authorize unapproved medical uses.
It would, however, remove a distinct layer of regulatory burdens that currently makes psilocybin research more difficult than research involving many substances with substantially greater addiction potential.
As Johnson emphasized, conducting studies with cocaine and methamphetamine is comparatively straightforward once the appropriate approvals have been obtained.
“It’s way easier to get supplies for them,” he said, referring to those drugs.
For psilocybin, by contrast, obtaining a reliable clinical supply remains a major challenge.
With psychedelic medicines advancing toward potential FDA approval, policymakers face a consequential decision: whether to reschedule only specific approved pharmaceutical formulations or the underlying psychedelic molecules themselves.
Johnson’s experiences suggest that leaving the underlying compounds in Schedule I would preserve many of the barriers obstructing independent research and further pharmaceutical development.
If the federal government wants to encourage scientific discovery, it should not make studying psilocybin more difficult than studying cocaine.
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Simple! Reflects who controls medical treatment for profit!