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.

Scientists Find 33 Genetic Markers In Marijuana That Can Be Targeted To
Breed New ‘Enhanced’ Strains ‘Tailored For Medical And Recreational Uses’

The post Marijuana’s Schedule I Status ‘Traps Researchers In A Paradox,’
Federally Funded Scientists Say appeared first on Marijuana Moment.