The Cost of Exclusion in Psychedelic Research

By Xinyuan Chen, Mackenzie Bullard, Christy Duan, Jamilah R. George, Terence Ching, Stephanie Kilpatrick, Jordan Sloshower, and Monnica Williams.

This essay previously appeared on Harvard Law School’s Bill of Health.

In the last two decades, researchers have started to reexamine psychedelics for their therapeutic potential. Though initial results seem promising, the research has a significant shortcoming: the lack of racial and ethnic diversity among research teams and study participants.

In the 1960s, psychedelic substances such as LSD, psilocybin, and mescaline were a major part of American counterculture. Less well-known is that, concurrently, researchers were studying potential therapeutic uses of these mind-altering substances. Unfortunately, psychedelics were classified as Schedule I drugs in 1970, halting research into their therapeutic benefits.

The recent renaissance of psychedelic research shows these substances have significant capabilities for treating anxiety, depression, posttraumatic stress disorder (PTSD), and substance use disorders. But these promising results are limited in their applicability: an analysis from 2018 showed that 82.3% of all study participants in psychedelic trials internationally were non-Hispanic Whites, and only 2.5% were African-American.

The Cost of Exclusion

The lack of diversity among research participants can have significant consequences on generalizability and distribution of treatments.

For psychedelic treatments especially, there is significant reason to believe that race dramatically affects psychedelic experiences, both inside and outside research settings. This assertion is in line with the concept of “set and setting,” a shorthand developed in the 1960s to refer to a list of non-pharmacological factors that greatly influence psychedelic effects.

In short, “set” refers to the personality, preparation, expectation, and intention of the person having the experience, while “setting” refers to the physical, social, and cultural environment where the experience takes place.

Psychedelic therapy, therefore, can be significantly impacted by the racial and cultural lens in which it is delivered. Moreover, the identities and lived experiences that both therapists and patients hold are critical components of set and setting, which must be considered when developing protocols for psychedelic therapies.

These effects are evident in an open letter by a cisgender male Chinese Singaporean gay/queer immigrant therapist and a recent study exploring the experiences of Black women therapists who were administered MDMA legally as part of a training trial for MDMA-assisted psychotherapy. The standard procedure in both cases consisted of an initial dosing session in a controlled environment, followed by a re-“integration” session some time later with another trained therapist. Specific themes of culture, identity, and upbringing were essential to each participant’s experience and subsequent integration In the aforementioned MDMA study, one respondent noted that she was not willing to fully discuss her experience with her assigned therapist during the debriefing “integration” session for fear that her culturally-specific insights would be misunderstood.

Thus, psychedelic therapists must understand the cultural backgrounds and contexts of their patients in order to be fully beneficent and reduce unintentional psychological harms.

The Promise of Culturally Attuned Care

In America, psychological distress rates for people of color are comparable to or higher than rates among non-Hispanic Whites.

For instance, the lifetime prevalence of PTSD in Black Americans is 8.03%, which is higher than the prevalence rate in Hispanic/Latino Americans (5.59%), Asian Americans (1.84%), and Non-Hispanic Whites (6.45%).

If psychedelic treatments are intended to benefit the entire American population, its protocols and treatments must be mindful of communities of color.

If culturally sensitive or “attuned” care is provided, psychedelic therapy even holds promise in treating race-based trauma. Race-based trauma is a condition stemming from an individual’s net exposure to racism, and shares similarities with PTSD. Since PTSD is one of the disorders for which psychedelic treatments have shown the most promise, they could also hold the key to unlocking a myriad of specific benefits for those suffering under racism.

Yet, the aforementioned lack of study participants of color prevents further investigation into this potential therapeutic application, and hampers the development of culturally attuned treatment models.

Barriers to Entry

Several factors influence racial inequalities in psychedelic research, with selection bias being a major one. Many people of color have increased suspicion and distrust around medical trials and illicit substances due to a combination of cultural stigma, unequal sentencing of drug infractions, immoral medical exploitation, and the federal government’s “War on Drugs” campaign. These historical elements are compounded by the time and financial constraints required to participate in clinical trials.

In order to recruit more people of color into these trials, researchers must employ a combination of strategies. At the outset, they should implement community outreach, paid advertising, cultural and anti-racism training, and meaningful compensation for participants’ time. Greater diversity among researchers and clinicians might also promote diversity among study participants. However, drawing on the literature of Critical Race Theory, systemic racism present throughout the biomedical sciences significantly stifles diversity among researchers and clinicians.

Another barrier to the participation of people of color in trials of psychedelics is a lack of governmental funding. As of 2018, all studies involving psychedelics in the United States have been performed with private funding. Unlike privately funded research, federally funded studies would be subject to the National Institutes of Health Revitalization Act of 1993, which explicitly requires the participation of racial and ethnic “minorities” and women in clinical trials. In other words, because psychedelic clinical trials are privately funded, they do not have to adhere to the same standards for ensuring that their sample populations are representative of the U.S. community at large. With MDMA and psilocybin gaining “breakthrough therapy” status from the FDA, and decriminalization measures recently passed by voters in Oregon and Washington, D.C., public demand for further inquiry may prompt public funding into more equitable trials.

Eliminating these barriers can make the future of psychedelic research and medicine more equitable. There have been many calls to action for researchers to conduct culturally inclusive and socially responsible research. As a developing field, psychedelic research presents a unique opportunity to make good on the promise of equitable treatment for all. The alternative is that these exciting new therapies merely continue to perpetuate the historically unequal and discriminatory nature of medical care in this country.

Contributing Authors’ Affiliations: Xinyuan Chen, BS; Mackenzie Bullard, MPH, Boston Medical Center, Department of Internal Medicine; Christy Duan, MD; Jamilah R. George, MDiv, University of Connecticut, Department of Psychological Sciences; Terence Ching, MS, Dartmouth-Hitchcock Medical Center, Department of Psychiatry; Stephanie Kilpatrick, PsyD, Post-traumatic Stress Center, New Haven, CT; Jordan Sloshower, MD, MSc, Yale University, Department of Psychiatry; Monnica Williams, PhD, University of Ottawa, School of Psychology.

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