People exist in a circle of life that includes both joy and sorrow. While illness, trauma and loss are inevitable parts of human life, suffering is optional. Suffering is a uniquely human experience that can add discomfort, despair and desperation to already difficult circumstances. Most medical research is aimed at treating disease but has had limited ability to address the human suffering associated with it.
The Heartland Palliadelic Research Center was created to compliment existing disease-based research by testing novel agents and interventions that help people with serious illness increase resilience and reduce suffering for themselves and thier families.
(palliate: to reduce suffering, -delic: to manifest or reveal) Is the study of novel interventions that reduce suffering in people with serious illness. Current research suggests an intervention combining psychedelic agents with supportive counseling promotes lasting improvements in well-being. Both healthy subjects and those dealing with serious illness, addiction and trauma have seen substantial and lasting benefits without serious side effect or ongoing medication use. Further research is required to prove effectiveness and optimal clinical delivery systems.
The depression and anxiety associated with cancer are common, difficult to treat and not generally responsive to medications. The graphs below are a sample of the findings of two recent randomized controlled trials addressing this problem. After a single intervention, as many as 80% of participants had immediate remission from depressive symptoms that were maintained for at least six months. The effects are clinically substantial with effect sizes that are twice that required to be labeled "large effect" in statistical terms. High quality, modern research with this intervention is still early in its development but the initial results are dramatic and worthy of further exploration and are consistent with the work done in the 1960s and '70s. In addition to the story the numbers tell, this link is one of the patients in the NYU study who told her story on film.
Ross, 2016 Rapid, clinically significant reduction in depression compared to placebo
Exploratory Pilot Trial
Status: Funded, protocol development
Sample Size: 12
Intervention: Moderately high-dose psilocybin (25 mg oral) with preparatory and integration counseling. Longitudinal, one year followup.
Anticipated Recruiting First Quarter 2021
Outcomes: psychological distress, well-being, neuronal activity(fMRI), health care utilization.
Parallel study exploring the impact of palliadelic treatment on family members of participants in the pancreatobiliary trial. Family members will report on their observations of the participant as well as their own distress and well-being. Family communications and communicated narrative sense making will be assessed. 12 month longitudinal followup.
Status: in development
Online survey to explore current awareness of medical psychedelics, attitudes toward psychedelics in general and acceptability of psychedelics in medical treatment and attitudinal barriers to tier use.
Dr. Lukas is the chief of Palliative Medicine at the Nebraska and Western Iowa Veterans Health Care Systems, the site director for the palliative medicine fellowship at UNMC, and an associate professor of Palliative Medicine at the University of Nebraska Medical Center .
Dr. Klute is an oncologist at the University of Nebraska Medical Center who specialized in treatment of pancreatic cancer and the research of novel treatment for GI cancers.
Dr. Kellas is a professor and chair of the Department of Communication Studies at the University of Nebraska -Lincoln. The overarching purpose of her research program is to study the ways in which narratives, storytelling, and related forms of communicated sense-making can help individuals and families understand, negotiate, and improve communication and coping within the context of difficulty and illness.
Dr Hwang is the director of research for the department of psychiatry at the University of Nebraska Medical Center. He is a neuroscience researcher specializing in neuro-image and clinical trials.
Ms. Vaughan is a pediatric psychiatric nurse practitioner with 20 years of expertise in clinical mood disorders, research instrument development, and research ethics.
Suffering appears to be a uniquely human phenomenon. While all animals experience pain, humans compound physical and emotional pain with stories and beliefs that can lead to maladaptive behaviors, negative mood states, social withdrawal, and substance abuse. These patterns of thought-these stories-appear to be held in the default mode network (DMN) of the brain, a large-scale network of interacting regions. The default mode network is active during passive rest and mind-wandering which usually involves thinking about others, thinking about one's self, remembering the past, and envisioning the future.
The neural connections in the DMN are created early in life and are augmented over time, they are so ingrained that they may appear to the individual to be an intrinsic part of themselves. This inherency makes it difficult to both recognize them as non-self and possibly even dangerous to attempt to change, yet change is necessary to avoid the ruminating thoughts and dysfunctional beliefs that fuel some depression and anxiety. By combining the study agent with tools for introspection and internal dialogue, we postulate that participants can reduce suffering and increase resilience by establishing new patterns and neural connections.
Recent developments in neuroimaging have shown us that the classic psychedelic agents (i.e. psilocybin, mescaline, LSD) and have a specific effect on downregulating the DMN, which may account for the transient loss of self/ego that is commonly described during experiences of these substances. Indigenous peoples have used these medicines for healing since prehistory. Western medicine actively explored their therapeutic benefits between the 1940s and 1970 during which time hundreds of papers were written describing beneficial results. This all came to a halt when they were caught up in the crack down on counter-cultural recreational use, criminalized and relegated to Schedule I classification, "no known medicinal use."
A number of researchers persevered and demonstrated that it was possible to continue research on a schedule I substance; by the 1990s several centers including Johns Hopkins, NYU, New Mexico, UCLA and MAPS developed productive research units. SInce that time research proving safety and establishing useful protocols have flourished. Several very promising phase two trials have led the FDA to grant both psilocybin and MDMA breakthrough designation. MDMA, while not a classic psychedelic, induces similar impact on suffering and is amenable to the same therapeutic intervention. Expanding high quality research will allow the FDA to define formal indications for both medications and reschedule them into categories that will make them available to patients though qualified clinicians.
Research into palliadelic interventions are not drug trials per se. Instead, they measure the impact of therapeutic events more akin to a single surgical procedure than a medication that requires daily administration. Like an orthopedic procedure that warrants a few weeks of physical therapy before and after, maximum therapeutic value from these substances requires a few hours of preparation to establish trust and set the intention for the intervention, and then a similar period following the session to integrate the insights from the immersion session.
The backlash to the cultural revolution of the 1960s led to the demonization of psychedelic substances. Most of the related stories of harm were exaggerated to discourage use. Of the thousands of people who took these substances, some people were harmed and a few died because of some combination of the following: taking an unknown substance reported to be a hallucinogen; inadequate supervision, preparation or integration; and possibly having pre-existing tendencies for organic psychosis. New research has demonstrated their physiologic safety (i.e. the classic psychedelics have no known LD50). They are, however, strong psychoactive substances that can have profound psychological impact. Context, supervision and appropriate participant selection is imperative. These medications are being advocated only for therapeutic use in the presence of qualified clinicians.
The FDA controls the safe use of drugs and devices. The approval of a new drug requires an expensive and time consuming process of research and testing. Following on the rigorous research of the last decade, the FDA has given psilocybin and MDMA "Breakthrough Status," which reduces barriers to the larger phase II and three trials required to establish effectiveness needed for full approval.
The DEA enforces the laws related to controlled substances, those medications that have some potential for abuse. Psilocybin and MDMA are still considered Schedule I substances, the category of drugs that are reported to have no medicinal value, because research to prove thier medicinal value is not complete. Johnson (2018) reports that psilocybin is consistent with medication currently in Schedule IV, drugs that have low abuse potential but should still be controlled to prevent unsafe usage. Until the drug is rescheduled, only people who are in approved clinical trials have legal access. All proposed research will follow strict adherence to local and federal laws and regulations.
Hopkins Psychedelic Research Program
NYU Psychedelic Research
Multidisciplinary Association of Psychedelic Studies
The Hefter Institute
Clinical Trials in Psychedelic Substances