The Biden administration’s proposal to reclassify marijuana as a lower-risk drug could create more research opportunities for colleges by removing barriers that exist because of its current status under the Controlled Substances Act.
The U.S. Department of Justice formally moved in May to recategorize marijuana from Schedule I, which covers drugs with a high risk for abuse and no recognized medical value, to Schedule III, which signifies a low to moderate risk for dependency and an accepted medical use. Heroin, LSD, and ecstasy are examples of Schedule I drugs. Ketamine, testosterone, and Tylenol with codeine are Schedule III.
The Drug Enforcement Administration, an agency of the DOJ, is soliciting public comment on the proposal through July 22. It has already received more than 26,000 submissions.
Rescheduling doesn’t mean legalization, and questions remain about how it would change the way the federal government regulates marijuana. But as more states have legalized the drug and the stigma against it has diminished, some health experts are concerned that use is on the rise even as long-term effects remain unclear. Cannabis researchers at colleges are optimistic that rescheduling will reduce some of the constraints on research, enabling them to pursue better understanding of this ubiquitous substance.
Here, we explain the current rules around cannabis research and how they could change.
How hard is it to study cannabis now?
Researching a Schedule I drug requires extensive paperwork and strict security. To obtain a Schedule I license from the DEA, researchers must submit information on how and why they plan to study the drug and how much of it they will need. Cannabis acquired must be stored in a safe bolted to the floor or wall.
Even if researchers take those steps, the applicability of their studies to real life is not guaranteed. The marijuana available to scientists often doesn’t match the high-potency supply on the market today.
Until recently, the University of Mississippi was the only place in the United States where scientists could obtain research-grade cannabis. For about 50 years, it maintained an exclusive contract with the National Institute on Drug Abuse to grow the plant.
But as states moved to legalize pot and the substance got stronger, scientists felt that the Mississippi product wasn’t a good proxy for the drug people were actually using. In 2021, the DEA expanded the list of approved sources of research cannabis. Researchers say the inventory from those companies is still limited, but should increase over time — and, they hope, offer a better mirror to the stuff on sale. (Mississippi is still supplying the federal government with marijuana.)
Jon Reuter, assistant vice chancellor for research integrity and compliance at the University of Colorado at Boulder, said he expects to see a “slow uptick” in research activity as more programs get hold of high-quality marijuana — until the drug is rescheduled to Schedule III.
“Then I think things are going to kick into high gear, at least for our campus,” he said.
How do we know what we know about cannabis?
In addition to studies that have used Schedule I permits, researchers have found workarounds, like relying on self-reported data or otherwise avoiding administering the drug themselves.
At Boulder, one research project has subjects buy themselves marijuana at a local dispensary. A “CannaVan” drives to the subject’s home to administer blood tests and behavioral assessments before and after the person consumes the drug. Then, scientists take the blood and observations back to campus.
“They can do that without a Schedule I license, because we’re not prescribing,” Reuter said. “We’re not telling the individuals what to do, how much to take, and we’re not buying it or procuring it or bringing it on campus. So it’s all the human subject who is taking ownership and following the legal status of the state laws.” (Marijuana is medically and recreationally legal in Colorado.)
Research in other countries has also helped advance scientific understanding of the potential medical purposes of cannabis, said Jason Kilmer, an associate professor in psychiatry and behavioral sciences at the University of Washington.
“If you think about what drives really good, well-controlled research, it tends to be federal funding,” Kilmer said. “If it’s a federal Schedule I drug, you’re not going to see a lot of research done in the U.S. that says, ‘We’re going to test the effects of cannabis on blank,’ because it’s like, why would you do that? There’s no medically recognized use.”
How much would the rescheduling affect marijuana research?
It would not open the floodgates. “The level of control might be a little easier with a Schedule III drug,” said Traci Toomey, director of the University of Minnesota School of Public Health’s Cannabis Research Center. “But there’s still some requirements, and there’s still an application process.”
Basic research should become more accessible. Reuter said he expected institutions that haven’t done much cannabis research to enter the space if some of the constraints were lifted.
“There’s a lot of people that have the tools, the technology, and the experience to study plants and herbal medicine and compounds,” he said. “But most people, because of the barriers involved, and the stigma with it, have focused on the other areas for funding that they have better success with.”
But experts are unsure whether the change will make testing cannabis in human beings any easier.
The Food and Drug Administration requires researchers who want to conduct clinical trials on unapproved products to submit applications detailing the manufacturing information for the drug and the protocols for the planned study. Getting FDA approval to test products that feature a temperamental plant like cannabis has proved challenging — and will likely continue to. The agency is more practiced with drugs that are made synthetically and can be easily duplicated, experts said. Researchers have complained that the FDA has been slow to review existing applications for cannabis clinical trials.
“The issue with marijuana is if you grow the same seed at different temperatures, with different soil, at different climates across the U.S., the composition of that plant changes,” Reuter said. “And so it’s very hard to ensure consistent development of that.”
The DEA, in response to an interview request from The Chronicle, said in an email that it does not “speculate on the outcome of proposed rules” during the rulemaking process.
Robert Welch, director of the National Center for Cannabis Research and Education at the University of Mississippi, said he hopes the rescheduling would make it easier to secure federal and industry funding for cannabis research.
“If it’s Schedule III, the pharma companies are gonna be like, ‘Oh, OK, we can easily conduct trials at these institutions,’ because most institutions have Schedule III licenses but not all have the Schedule I,” he said.
What kinds of research might scholars do if it were easier?
Toomey, at the University of Minnesota, said it would be interesting to administer varying doses of cannabis to subjects and then get them into a driving simulator on campus.
She wasn’t sure whether this would be possible under Schedule III, but thought it was at least worth asking. There was other research she would like to do that she believed would be possible only if cannabis were descheduled — removed entirely from the Controlled Substances Act.
That includes sending people who look underage into dispensaries to attempt to purchase marijuana. UMN researchers wanted to do this before, in California, but because cannabis was Schedule I, they adjusted their protocols to have underage-looking people simply try to enter dispensaries without an age identification.
Referring to the original purchase-attempt idea, “No attorney was going to say, ‘Oh yeah, let’s go for that,’” Toomey said.
What is the timeline?
It may take a while before anything changes. The public-comment period for the proposal closes July 22. The DEA, in an email to The Chronicle, said it does not yet have a timeline for the publication of the final rule.
The process coincides with the Supreme Court’s decision last week to end the Chevron doctrine, which held that courts should defer to federal agencies on rulemaking.
Alex Kreit, an assistant professor and director of the Center on Addiction Law and Policy at Northern Kentucky University’s law school, said the Supreme Court ruling doesn’t take away the DEA’s authority to reschedule marijuana. But it does add some uncertainty about how a federal court would rule if marijuana were rescheduled and that new classification were challenged.
Courts no longer have to defer to the DEA’s existing interpretation of the Controlled Substances Act, which Kreit said “has been key to preventing marijuana rescheduling.”
“If and when this issue gets litigated in court, you know, it’s quite possible that the end result is the court upholds rescheduling,” Kreit said.
Experts said they didn’t expect anything to change for at least a year.
“There’s been a lot of excitement,” Reuter said. “My job is to curtail that excitement, because nothing’s going to happen fast.”
