Federal health officials claim that psychedelics are “promising therapeutic agents” but research has been hindered by the federal ban. The group also argues that when the Food and Drug Administration considers approving substances such as psilocybin it is important to take into account issues like accessibility, affordability and reimbursement for health care.
In a Wednesday opinion piece in the Journal of the American Medical Association Psychiatry (JAMA), National Institute on Drug Abuse Director Nora Volkow, and National Institute of Mental Health Director Joshua Gordon discussed the rapid rise in interest in psychedelic drugs as early studies revealed that they could effectively treat serious mental conditions.
The officials noted that, as with marijuana research, psychedelics present “unique challenges”, due to “administrative obstacles” posed by their Schedule I classification under the Controlled Substances Act. Volkow and Gordon wrote.
Clinical trials of psychedelics face unique challenges. These include administrative obstacles resulting from the Schedule I status.
The essay, co-authored by Eric M. Wargo of NIDA, touches on two key issues that have emerged since the implementation of laws regulating access to certain psychoactive substances in two states: affordability and accessibility.
It is important that everyone has access to psychedelic assisted treatments, should they be available. They said that they should be affordable. They said that, given the time-intensive nature of therapy, people who have work, family or transportation issues should be accommodated.
They also said that research on psychedelics should be inclusive. This may be a unique challenge, given the “baggage” of past ethical transgressions including the egregious experiments with LSD conducted on study participants who were not aware they were taking part.
Researchers are under a special obligation to be transparent about their goals and methods, and to build a solid foundation of trust with the study participants. They wrote that because of this dark history, some people in racial or ethnic minority groups are hesitant to take part in research. “Yet, inclusion of diverse study population is necessary to ensure findings are applicable for individuals with different demographic characteristics.”
Officials also presented a list of research questions that will be addressed in future trials. They say it is “important” that we learn whether the subjective experience is “intrinsic” or “separable” from therapeutic effects. This could be used to develop new medicines as “cognitive distortions and sensory distortions of intoxication from psychedelics raise questions about the safety of these drugs.”
The opinion piece touches on “set and setting”, and the role that facilitators play in psychedelic-assisted therapy.
Existing clinical trials of psychedelics usually involve only one or two clinicians who administer the substance. “There is no standard protocol to prepare patients for the experience, help them through it, and then process it afterwards.”
They wrote: “Some have suggested the clinician’s attention and time is a significant component of psychedelics therapeutic effects. However, there has been no rigorous testing of this hypothesis to our knowledge.”
Officials did try to temper the enthusiasm for psychedelics, stating that “therapeutic data on classic psychedelics remain limited.” However, they acknowledged that some early studies found that psilocybin could be a new therapeutic intervention when it comes to depression and addiction.
They said, however, that despite “promising results early on, it is clear that the hype has gotten in front of the science” and that psychedelics were not miracle drugs.
They said: “This is similar to what happened with the medical cannabis industry. Regulations pertaining its medical use were approved and promoted a booming marijuana industry, despite a lack of scientific evidence of its therapeutic efficacy.”
The public’s response to psychedelics may be disproportionate due to “hype”, but Volkow and Gordon ended their paper with a positive note. They wrote, “Challenges aside, the promise psychedelics-related research holds goes beyond the promise for new pharmacotherapies.”
We know much about the brains that are affected by mental illness, including substance abuse disorders. But we don’t know what happens in the brains in people who have meaningful and connected lives and may be less susceptible to developing psychiatric illnesses. It would be valuable to better understand the mechanisms that psychedelics use to increase resilience.
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.
They wrote: “The immediate need for research is to focus on how rapid-acting treatments can be applied in real life.” Treatments that can be delivered in a matter of hours or days, rather than weeks, have the potential to reduce morbidity and death and improve care. They also reduce the need for intensive interventions like inpatient hospitalization. This potential will only be realized when research is done to answer key questions on how they can be used effectively.
FDA is taking its own steps to encourage research on psychedelic therapy. The agency has recently released the first draft guidance for scientists on how to best study entheogenic compounds in the interest drug development.
NIDA called earlier this month for research on the impacts of changing laws surrounding psychedelics. This includes the effects of allowing controlled access to substances such as psilocybin.
NIDA announced separately in May that they are soliciting proposals to fund a series research initiatives to investigate how psychedelics can be used to treat addiction to drugs. They plan to spend $1.5 million to fund relevant studies.
In May, Volkow informed members of a Senate Committee that new evidence is emerging that psychedelics have “significant potential” to treat certain mental conditions. This topic is “of great interest” to researchers.
Last year, Sens. Brian Schatz, D-HI and Cory Booker, D-NJ, urged top federal officials to give an update on studies into the therapeutic potentials of psychedelics. They argued that federal prohibition had stymied research.
NIDA’s response to the question was that the federal prohibition made it harder to study the benefits of psychedelics and required researchers to jump through extra regulatory hoops. Volkow said previously that she hesitates personally to study Schedule I drug due to these complications.
In 2021, the director told Marijuana Moment that researchers should prioritize psychedelics research because more people will use the substances as they are exposed to studies that show their therapeutic potential.
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