DEI and Psychedelic Medicine

General

• Psychedelics are defined here as substances that exert their effects through serotonin 5HT2A agonism including psilocybin, mescalin, dimethyltryptamine (DMT), and lysergic acid diethylamide (LSD).[1][2][3] We also consider methylenedioxymethamphetamine (MDMA) under the umbrella of psychedelics, although distinction can be made that MDMA is uniquely an entactogen, given its unique and prosocial effects.​[4]​
• This section is focused on human subjects’ research of psychedelics to treat psychiatric illness. In this field of study, extra-pharmacological aspects of the treatment are important, including psychedelic assisted psychotherapy (PAP), set, and setting.[5][6]​ Set is defined as the expectation, preparation, and intention that make up the psychological or internal environment. Setting is defined as the physical and social environments that are created around treatment that make up the external environment. [7] ​​

Unfortunately, psychedelic studies are lacking in ethnic and racial diversity of participants​[8]​, calling into question the generalizability of their findings.​[9][10] Not only are Black, Indigenous, People of Color (BIPOC) underrepresented, but so are people with LGBTQIA+ identities, as well as people with intersectional identities.

• Diversity is not only important for scientific rigor and generalizability of study findings, but it also helps to enrich understanding of best treatment practices around set, setting, and psychotherapy. For example, new methods for music selection that help make up the setting for psychedelic dosing have been used to be more inclusive of minoritized groups.[11]​
• To address the lack of diversity in clinical trials research, the NIH created the Revitalization Act of 1993. This established guidelines for the inclusion of women and underrepresented racial and ethnic populations in clinical research.[12] ​Yet, recent estimates in the field of psychedelic research have noted that 82.3% of participants identify as white and male.[9]
• Improving diversity in psychedelics research in a thoughtful way will not only raise ethical standards of the research practice but will also contribute by making methods of psychedelic assisted psychotherapy, set, and setting more nuanced.

Seminal Works and Ideas for Inclusion of Participants from Diverse Background in Psychedelic Medical Research

This section lists examples and offers suggestions for engaging Black, Indigenous, People of Color (BIPOC), LGBTQIA+ identifying people, as well as people with intersectional identities in research studies focused on psychedelic centered therapies.

• Culturally informed research design of a study of MDMA assisted psychotherapy in PTSD was done by Monnica Williams et al. Below are some examples of culturally informed research designs they implemented: ​[11]
  • Have diverse and well-qualified team leaders.
  • Use culturally attuned recruitment strategies. For example, in communications to potential participants, use names and pictures of study staff.
  • Provide psychoeducation relevant to the study to participants.
  • In recruitment, use language addressing fears of death, disability, and addiction; and language about the site’s culturally sensitive and respectful treatment approach.
  • Train therapy providers in topics such as ethnic identity development, therapeutic distance based on ethnic identity, models of acculturation, whiteness and privilege, racism and micro aggressions, racial trauma, personality disorders and culture, and cultural issues relevant to use of study measures.
• The Multidisciplinary Association for Psychedelic Studies (MAPS) in 2020 announced a commitment to improving access and diversity. They established an advisory council, requiring therapists and independent raters to complete training on racial justice and preventing microaggressions, providing participant reimbursement at select study sites for study-related costs, and prioritizing interested volunteers who identify as people of color (POC). With this approach they were able to double representation of POC in their phase 3 clinical studies on MDMA assisted therapy for the treatment of PTSD from 12 to 27% .
  • Some concrete actions suggested by Christ et al. to create queer-affirming set and setting in psychedelic research studies and practice include the following:[13][14]​
    • Get Educated: Train to understand prejudice and discrimination faced by queer individuals and practice cultural humility.
    • Address Misgivings: Be familiar with past injustices in psychedelic therapy as well as the fact the “Homosexuality” and “Gender Identity Disorder” were both part of the DSM in the past, although now those diagnoses have been delegitimized.
    • Terminology and Language Mirroring: Listen attentively and mirror language participants use to describe their own sexual and gender identity with an understanding that terminology is evolving.
    • Queer the Dosing Space: some examples include displaying safe space indicators such as pride flags, queer affirming art, employing queer office staff, and having gender neutral bathrooms.
  • Set may include honoring aspects of one’s gender and sexual identity. For example, asking participants what it means to be queer and what role that identity plays in one’s life can be explored in intake assessments and preparation appointments. Additionally, the setting includes social and cultural aspects of the environment, not just decor. In our society there are conscious and unconscious supports of racism, misogyny, homo/bi/transphobia; taking these into account can allow for more intentional creation of the setting. ​[15]
• Collect demographic data about the way participants identify, including ethnicity, race, gender and sexual orientation. Also, collect data about intersectional identities. FDA has guidelines for collecting data on race and ethnicity in clinical trials.​[16]
  • In terms of collecting data on gender identity and sexual orientation, Mckernan and Belser propose a uniform assessment of sexual and gender minority (SGM) people to allow for further analysis. They also point out that heteronormative assessment procedures may propagate minority stress, the distress put upon SGM in the form of stigma, prejudice, harassment, discrimination and identity-based violence.[17]​​
• Cultural formulation calls for systematic assessment of cultural identity of the individual, cultural concepts of distress, psychological stressors and cultural features of vulnerability and resilience, cultural features of the relationship between the individual and the clinician, treatment team and institution, as well as overall cultural assessment (DMS-5). The cultural formulation can be a starting place for approaching identities not specifically addressed here.

Additional Justice Equity Diversity and Community Engagement (JEDI-CE) Considerations in Psychedelics Research

• Race and ethnicity have been shown to affect the association between psilocybin use and various markers of mental wellbeing.[18]
• Psychedelics may decrease the negative impacts of racial trauma among BIPOC individuals.[19] Similar results were found among a sample of the Asian population in North America.​[20]
• Katson D Anderson-Carpenter highlights black queer intersectional identity. Psychedelic practices have been used as a way of gaining self-acceptance in the context of the oppression Black queer individuals face in so-called “Western society.”[21]​ This is a topic of interest that requires further study.
• Celidwen et al. detail 8 ethical principles conceived by a global indigenous-led group to address the use of indigenous medicine in so-called “Western” psychedelic research and practice.​[22]
• Hopkins-Oxford Psychedelics Ethics (HOPE) Working Group consensus statement published a set of ethical considerations related to psychedelics along with some recommendations. These considerations include but are not limited to, recognition of communities with historical use of psychedelics, recognition of the legitimacy of diverse motivations to engage with psychedelics, and an equity-oriented approach to psychedelic services.[23] ​

Path Forward

At Johns Hopkins, the Center for Psychedelics and Consciousness Research (CPCR) gathered a committee for Justice Equity Diversity and Community Engagement (JEDI-CE). JEDI-CE is a useful paradigm to consider when reviewing plans for human subjects’ clinical trials. The following section is a list of approaches that aims to promote JEDI-CE in this field of study.

• Understand barriers in recruitment, assessment, and retention of diverse participant populations in psychedelics research.
• Appreciate the need for a level of cultural humility to minimize harms and take diversity of participant population into account when making plans for set and setting.
• Recognize that medical mistrust is a barrier to a safe and comfortable “Set.” historical events may contribute to mistrust from Black, Indigenous, People of color and LGBTQIA+ participants.[24][25]​
• Learn about relevant historical events and current disparities that may affect trust among minoritized groups in the location of your research.[26]​
• Overcome the bias that minority populations are less interested in psychedelics by understanding that BIPOC research participants may be more likely to seek out psychedelic assisted psychotherapy after psychoeducation in various forms.​[27]
• Understand the harms that can be caused to participants from diverse backgrounds in psychedelic research practices, when the set and setting are not culturally attuned.
• Demonstrate respect for indigenous people by acknowledging that there are a variety of belief systems around what we call “psychedelic medicines,” which precede present inquiries that use the scientific method as a paradigm for understanding.