"Certain demographic groups have been the recipients of more legal scrutiny related to substance use than the majority of the population,” says lead researcher Cody Wenthur.
Ensuring equity in psychedelic therapies as they become more widely available is a challenge, but a new University of Wisconsin Madison (UW-Madison) study hopes to unlock the key to designing clinical trials that will attract a greater diversity of participants and, in turn, lead to more effective therapies.
The two-year research project, being funded by the Wisconsin Alumni Research Foundation, will connect with diverse groups to better understand barriers preventing non-white study participants from enrolling in psychedelic clinical trials, in addition to exploring the influence of clinical space’s art on the recruitment and retention of minority populations in psychedelic studies.
Despite mandates by the United States National Institutes of Health’s Revitalization Act of 1993, which requires clinical research to include minority populations, studies in the psychedelics space are whiter than the average population across the country.
According to a 2018 review of the inclusion of people of color in psychedelic-assisted psychotherapy, all minorities are greatly underrepresented in psychedelic medicine studies and as a result reported treatment outcomes may not generalize to all ethnic and cultural groups. “Inclusion of minorities in future studies and improved recruitment strategies are necessary to better understand the efficacy of psychedelic-assisted psychotherapy in people of color and provide all with equal opportunities for involvement in this potentially promising treatment paradigm,” researchers concluded.
The UW-Madison study is being led by School of Pharmacy Assistant Professor Cody Wenthur. After a successful focus group earlier this year, which allowed Wenthur to collect data on local attitudes and potential hurdles to reversing trends of minority underrepresentation, he will be expanding this work across other regions of the United States to hear from different demographic populations. Focus groups will be directed at Black, Latinx, and Indigenous communities.
“Indigenous cultures have long been the stewards of this this type of knowledge and their practices are foundation to a lot of the protocols of current clinical trials,” Wenthur explained in an article on UW-Madison’s School of Pharmacy website. “Yet, they are underrepresented in these very same trials and are at risk of not seeing the benefits from the legitimization of the medical use model for these compounds.”
The UW-Madison focus groups may also provide insights into issues such as lack of childcare or transportation as barriers to enrollment in clinical trials, as study participants often have to stay on-site for 10 to 12 hours. It is hoped that these interactions will help improve both oral communication between researchers and subjects and written language in study protocols to make sure they are accessible to potential participants from diverse backgrounds.
“As illegal Schedule I compounds are now entering clinical trials as investigational drugs, we have to recognize that there is a social dynamic to the use of these substances and that certain demographic groups have been the recipients of more legal scrutiny related to substance use than the majority of the population,” Wenthur said. “Closing health gaps must be a priority if we want to effectively address the heavy burden of mental health disorders present in America right now.”
Wenthur’s research is also exploring art’s role in inclusion because the setting in which psychedelic treatments occur is thought to be a mediator of therapeutic effect. For the study, participants will engage in an art selection process through the use of the UW-Madison digital collections, where they will have the opportunity to browse a catalog of works and select the art that they find meaningful before their first session.
“We are starting with artwork as a traceable way to address one variable in the study setting,” Wenthur said. “By providing the opportunity to tailor the setting to what an individual finds most therapeutically beneficial or feels most comfortable to them, we can potentially maximize the benefit of the therapy.”