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Top Federal Health Officials Say Psychedelics’ Schedule I Status Creates ‘Hurdles’ To Studying Them



Top federal health officials say that psychedelics have “promising” therapeutic potential—but research into them has been stymied by ongoing federal prohibition. They also argue that as the Food and Drug Administration (FDA) considers approving substances like psilocybin, it’s important to look at issues such as accessibility, affordability, health care reimbursements and ethics.

In an opinion piece published in the Journal of the American Medical Association (JAMA) Psychiatry on Wednesday, National Institute on Drug Abuse (NIDA) Director Nora Volkow and National Institute of Mental Health (NIMH) Director Joshua Gordon discussed how interest in psychedelic medicines has risen rapidly as early studies have revealed evidence that they may effectively treat serious mental health conditions.

But as with marijuana, the officials said, researchers face “unique challenges” to conducting research on psychedelics due to the “administrative hurdles” presented by their Schedule I status under the Controlled Substances Act (CSA), Volkow and Gordon wrote.

“Conducting clinical trials on psychedelics faces unique challenges, including administrative hurdles resulting from their Schedule I status.”

Interestingly, the essay, which is coauthored by NIDA’s Eric M. Wargo, also touches on a key issue that’s emerged as two states implement laws providing for regulated access to certain psychedelics: accessibility and affordability.

“It is crucial that psychedelic-assisted treatments, if they become available, are available to everyone. That means they should be affordable,” they said. “And given how time intensive the therapy may be, there should be accommodations for people with work, family, or transportation challenges.”

Also, research into psychedelics must be carried out in a way that’s inclusive, they said. And that may be uniquely challenging given the historical “baggage of past ethical transgressions, including egregious experimentation with LSD on unwitting study ‘participants’ including individuals with disabilities and those who were incarcerated in the 1950s.”

“It places a unique burden on researchers to be transparent in their aims and methods and to establish a firm grounding of trust with study participants. Because of that dark history, people from racial and ethnic minoritized groups may be particularly hesitant to participate in research,” they wrote. “Yet inclusion of diverse study populations is necessary to ensure that findings are applicable across individuals with varying demographic characteristics.”

The officials also outlined several research questions for trials going forward. One thing that they say is “important” to learn is whether the subjective experience of the psychedelic trip is “intrinsic to or separable” from the therapeutic effects. That could help inform the development of medicines, as the “cognitive and sensory distortions” of being intoxicated from psychedelics raises “questions about the safety of psychedelic drugs.”

The opinion piece also touches on the concept of “set and setting” and the role of facilitators in psychedelic assisted-therapy.

Existing clinical trials on psychedelics typically involve one or two clinicians administering the substance, but “no standard protocol yet exists to prepare the patient for the experience, support them during it, and help them process it afterward.”

“Some have suggested that the clinician’s time and attention accounts for a nontrivial component of psychedelics’ therapeutic effects, but there have been no rigorous tests of that hypothesis, to our knowledge,” they wrote.

The officials did seek to temper enthusiasm around psychedelics somewhat, saying that “therapeutic evidence for classic psychedelics remains limited.” But they also acknowledged that early studies have found that psilocybin in particular could potentially serve as a novel therapeutic intervention in the treatment of depression and addiction.

However, they said that despite the “promising early results, it is clear that psychedelics are not wonder drugs, but the hype has gotten ahead of the science.”

“This is reminiscent of what happened with medical cannabis: regulations pertaining to its medical use were approved, promoting a booming cannabis industry, despite lack of scientific evidence for its therapeutic efficacy,” they said.

Volkow and Gordon might consider the public response to psychedelics outsized due to the “hype,” but they ended their opinion paper on an optimistic note, writing that, “Challenges notwithstanding, the promise of psychedelics research goes beyond the promise of new pharmacotherapies.”

“Declining life expectancy among US residents in recent years has been tied to despair—overdoses, suicides, and diseases attributable to alcohol misuse all reflect large swaths of society feeling increased pain and loss of connection.We know a great deal about what goes awry in the brains of people with mental illnesses including substance use disorders, but we know less about what goes right in the brains of people whose lives are full of meaning and connection and who may be more resilient to the development of psychiatric conditions. Better understanding of the mechanisms by which psychedelics may increase resilience could be highly valuable.”

Volkow, Gordon and National Institute on Alcohol Abuse and Alcoholism (NIAAA) Director George Koob also recently published a separate paper in the journal Neuropsychopharmacology that calls for a “strengthened and modernized research agenda” that prioritizes novel therapeutics such as ketamine, psilocybin and MDMA in the treatment of mental health conditions like depression and alcoholism.

“The most immediate need is for research that focuses on how these rapid acting treatments can be used in the real world,” they wrote. “Treatments that work in hours or days instead of weeks have the potential to significantly reduce morbidity and mortality and to improve care and reduce the need for intensive interventions such as inpatient hospitalization. But this potential can only be realized if research answers key questions about how to use them effectively.”

FDA, for its part, is also taking steps to facilitate research into psychedelic therapies. Not only has it designated psilocybin and MDMA as “breakthrough therapies,” but the agency recently released first-ever draft guidance to scientists on best practices to study the entheogenic substances in the interest of drug development.

Earlier this month, NIDA also called for research into the impact of evolving laws around psychedelics, including the effects of allowing regulated access to substances like psilocybin.

NIDA separately announced in May that it is soliciting proposals for a series of research initiatives meant to explore how psychedelics could be used to treat drug addiction, with plans to provide $1.5 million in funding to support relevant studies.

At a Senate committee hearing in May, Volkow told members that there’s emerging evidence that psychedelics carry “significant potential” as therapeutic treatments for certain mental health conditions, and it’s a topic of “great interest” for researchers.

Last year, Sens. Brian Schatz (D-HI) and Cory Booker (D-NJ) pushed top federal officials to provide an update on research into the therapeutic potential of psychedelics, arguing that ongoing federal prohibition has stymied studies.

NIDA responded to the inquiry by saying that federal prohibition makes it more difficult to study the benefits of psychedelics, requiring researchers to jump through additional regulatory hoops. Volkow previously said that she personally hesitates to study Schedule I drugs because of those complications.

The director told Marijuana Moment in 2021 that researchers need to prioritize psychedelics research, as more people are likely to use them as they’re exposed to studies showing the therapeutic potential of the substances.

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Photo elements courtesy of carlosemmaskype and Apollo.

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