Exploring Psychedelics and Entactogens as Treatments for Psychiatric Disorders Proceedings of a Workshop (2022) / Chapter Skim
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5 Anticipating Implementation to Guide Clinical Research and Development
5 Anticipating Implementation to Guide Clinical Research and Development
Pages 47-58
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From page 47... ...
. • Multiple access dimensions require consideration, including risk factor management, quality and consistency of care, train ing of a diverse and culturally humble workforce, financial issues such as insurance and reimbursement, social and eco nomic determinants of health, health literacy, stigma, and trust (Simon)
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From page 48... ...
They are not intended to reflect a consensus among workshop participants. Assuming the efficacy of psychedelics and related compounds is demonstrated for the treatment of mental disorders, the actual benefit derived from implementing these medications in clinical practice is going to depend on a variety of issues, said Paul Appelbaum, the Elizabeth K
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From page 49... ...
Not only people of color, but other minoritized populations, such as LGBTQIA+ people, experience significant health disparities compared with heterosexual and cisgender people, added Caroline Dorsen, associate dean of clinical partnerships at the Rutgers University School of Nursing. She added that many of the health care disparities that are especially prominent among LGBTQIA+ people are in the same areas that psychedelics hold promise to address -- depression, anxiety, suicidality, and substance 1 According to the U.S.
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From page 50... ...
Dorsen noted, however, that there are few data regarding the participation of LGBTQIA+ people in clinical studies because sexual orientation and gender identity data may not be collected from clinical trial participants. Diversity among researchers and clinicians is also critical to the impact on -- and how connected the research studies are to -- minoritized populations, she said.
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From page 51... ...
She added that the Black community is "all about it takes a village." When recommending a course of psychedelic therapy, she suggested allowing them to bring a relative or friend to one of the preparatory sessions, and exposing them to stories of Black and Brown people who have experienced psychedelic therapy would also be helpful, she said. People also want to know that there are people who look like them among the principal investigators and mental health professionals, said Dudley.
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From page 52... ...
Nurses may have a particularly important role to play in the scalability and d elivery of psychedelic therapy because nurses try to "be present for people in illness and in health and see them through vulnerable moments in life," said Dorsen. She suggested there could be roles for many different types of nurses in the psychedelics space, including registered nurses and mental health nurse practitioners who are trained to do psychotherapy as well as doctorally prepared nurses with expertise in quality improvement who can ensure accurate translation of knowledge from clinical trials into the more complicated real-world space.
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From page 53... ...
While psychedelic investigators today must follow a careful regulatory pathway, federal laws, and institutional rules, problems still exist, and there is no consensus about basic ethical questions related to the psychedelic clinical encounter, such as whether it is ever acceptable for researchers or clinicians to touch patients, he said. While some researchers address this question in informed consent and preparatory sessions and try to mitigate the risk through the use of video recording, Sisti said these measures do not always work, resulting in disturbing cases of sexual and psychological abuse in both research and "quasi-underground clinical settings." He added that certain kinds of touch may be effective and appropriate in therapeutic settings, although even well-intentioned touch may trigger or worsen trauma.
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From page 54... ...
for posttraumatic stress disorder (PTSD) , Lori Tipton endorsed the idea of community models of care as a means of reducing barriers that exclude many people in need, especially the historically marginalized.
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From page 55... ...
Looking ahead to upcoming psychedelic therapies should they be approved, Levine said that to achieve broad, safe, and equitable patient access, there will need to be a coding and reimbursement structure in place that is understood by providers and payers and financially viable for them. "In other words, there is a risk that we develop paradigm-shifting new treatments that never get to the patients who may benefit from them and a possible divergence to less regulated routes to access with the accompanying risks or harms," said Levine.
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From page 56... ...
Dorsen suggested that these communities could also provide valuable lessons around the practice of delivering psychedelic therapy in group and community settings. This approach could not only increase access and decrease financial burden but may also provide other benefits in terms of reducing the social isolation and lack of connection that may underlie depression, anxiety, and substance abuse.
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From page 57... ...
GUIDE CLINICAL RESEARCH AND DEVELOPMENT 57 likely to benefit from a group setting; how should the groups be constituted, for example, would people be grouped on the basis of their life experiences or diagnoses? What sort of preparation and integration would be needed?
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