Marijuana’s Schedule I Status ‘Traps Researchers In A Paradox,’ Federally Funded Scientists Say

Researchers involved in a federally funded clinical trial around marijuana write in a new article in the American Journal of Medicine that further study into the substance is of “critical importance” given the millions of patients and consumers in legal states, but they warn that government restrictions “stifle scientific exploration of its potential and risks.”

Classifying cannabis as a Schedule I substance, write authors from the University of Maryland (UMD) schools of medicine and nursing, “traps researchers in a paradox: proving medical value requires studies, yet studies are heavily restricted.”

“As legalization outpaces science,” the paper says, “reform is imperative to close the evidence gap and meet society’s demands.”

To expedite studies into marijuana’s potential and avoid reliance on untested claims, the researchers say moving the substance to Schedule III would ease restrictive oversight by the U.S. Drug Enforcement Administration (DEA). More National Institutes of Health (NIH) funding—along with easier access to government-approved supplies of cannabis—could also accelerate trials, they say.

“Legislation like the Medical Marijuana Research Act, stalled since 2019, merits revival,” the commentary says, also encouraging fellow scientists to “harness public support to dismantle barriers, ensuring cannabis’s risks and benefits are understood.”

Dr. Raya Elfadel Kheirbek, the lead author of the paper and a professor at the UMD School of Medicine, told Marijuana Moment in an email that authors were inspired to write the piece by their experience conducting a federally funded, multisite clinical study into the use of THC and CBD as an end-of-life treatment for agitation in people with dementia.

“The regulatory and operational complexities we faced in preparing our site for patient enrollment inspired many of the concerns raised in the article,” Kheirbek said. “From navigating the DEA licensure process, securing specialized storage and handling procedures, to establishing an [investigational new drug]-compliant workflow and payment system for participants and caregivers, every step involved protracted timelines, unexpected costs, and multiple layers of institutional and federal review.”

“These experiences illustrate why so few academic centers are willing or able to pursue cannabis-related clinical research despite widespread clinical interest,” she said.

Kheirbek added that while rescheduling would help ease some DEA-related research burdens, it wouldn’t be sufficient to “address systemic underfunding or the institutional hesitancy rooted in decades of stigma.”

“Public health and equity are at stake,” she wrote. “Providers are being asked to advise patients on cannabis without adequate data, while underserved communities continue to face barriers to participation and benefit from the research enterprise.”

In addition to ongoing stigma and scarce institutional funding, the new American Journal of Medicine commentary adds that having to navigate multiple federal agencies—including DEA, the U.S. Food and Drug Administration (FDA), NIH and others—”amplifies complexity” of research.

Another obstacle to research highlighted in the paper is the limited supply of National Institute on Drug Abuse (NIDA)-approved marijuana.

“Historically, research cannabis was sourced solely from the University of Mississippi through NIDA, offering low-potency, unrepresentative strains,” it says. In 2016 DEA pledged to license more growers, but that promise “materialized slowly, with only a few new suppliers active by 2025, limiting access to diverse, market-relevant cannabis.”

In April of this year, the University of Mississippi was selected to house NIH’s new Resource Center for Cannabis and Cannabinoid Research (R3CR), a cannabis research lab the agency first announced in late 2023.

The college will be partnering with Washington State University (WSU) and the United States Pharmacopoeia (USP), with support from a grant awarded by the National Center for Complementary and Integrative Health (NCCIH) under NIH.

Donald Stanford, assistant director of the University of Mississippi’s Research Institute of Pharmaceutical Sciences, said R3CR will raise attention to “significant changes in the landscape of cannabis research.”

When NIH announced its plans to create a cannabis research center and solicited proposals from potential partners, a top official at NCCIH said the agency recognized that there are ample concerns among scientists about how they’ve “encountered barriers that have hampered their research” into marijuana under federal prohibition, including “complex” federal regulations and inadequate supplies of cannabis.

Meanwhile, DEA earlier this year notified an agency judge that the marijuana rescheduling process is still on hold—with no future actions currently scheduled as the matter sits before the acting administrator, who has called cannabis a “gateway drug” and linked its use to psychosis.

Separately at Ole Miss, the federal Department of Government Efficiency (DOGE) in May cut funding for a separate program that tracks potency of marijuana seized by law enforcement.

The head of the longtime told Marijuana Moment at the time that it’s still possible his work could limp along until funding resumes, but if samples stop flowing, a decades-long history of THC levels in the illicit U.S. cannabis supply will soon come to an end.

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