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Pilot Study

Pilot Study

Psilocybin to address COVID -19 related psychological distress

Keith Heinzerling MD, Christopher Adrian MD, Francoise Bourzat, Daniel F. Kelly MD

pilot study

Background​

The worldwide coronavirus pandemic (COVID-19) has produced widespread and unprecedented impacts on society including stress and social isolation that are likely to result in a major increase in mental health and substance use disorders (Bavel et al., 2020; Volkow, 2020). Threat of infection and illness for oneself and one’s loved ones, uncertainty related to the upheaval of the economy, and mounting social and political tensions are major stressors while at the same time social and physical isolation resulting from stay-at-home and quarantine orders have eroded usual support and coping mechanisms (Matias et al., 2020). For example, people are isolated from family, friends, religious and social communities and face new barriers to accessing mental health and substance use treatment services (Freeman, 2020; Marsden et al., 2020).

Rising mortality rates are likely to be followed by a spike in prolonged and complicated grief due to disruption of the usual bereavement activities as families are unable to visit their loved ones at the end of life or congregate for funerals due to quarantine and social distancing requirements (Eisma et al., 2020). The conditions faced by frontline healthcare workers and first responders caring for COVID-19 patients, including stress related to hospitals overwhelmed by the high volume of critically ill patients, lack of effective treatments, shortages of personal protective equipment (PPE), and the threat of infection and transmission to their families, put these workers at very high risk of COVID-19-related depression, anxiety, PTSD, drug/alcohol problems, and suicide (Jiang & Flores, 2020; Lai et al., 2020). Together, these suggest that the second wave of the COVID-19 pandemic is likely to be an epidemic of mental health and substance abuse problems.

Existing treatments for mental health and substance use disorders are available but are modestly effective overall and ineffective for some patients. Remission rates for depression, anxiety, or PTSD following treatment with antidepressants and cognitive therapy are in the 25% to 50% (Koek et al., 2016; Pandarakalam, 2018; Patterson & Van Ameringen, 2016). Rates of relapse with pharmacotherapy plus behavioral therapy for alcohol and drug use disorders are as high as 50-80% (Anton et al., 2006; Lee et al., 2018).

Novel and more effective treatments for mental health and substance use disorders are urgently needed to address the surge in COVID-19-related psychological distress. Psychedelic-assisted therapy is a ground-breaking approach that uses psychedelic drugs administered under medical supervision to alter a patient’s consciousness in a therapeutic way.

Psilocybin, the naturally-occurring hallucinogen found in so-called “magic mushrooms” has shown considerable promise in early clinical trials for depression, anxiety, and end-of-life existential crisis (Carhart-Harris et al., 2018; Griffiths et al., 2016; Johnson & Griffiths, 2017). Effect sizes for psilocybin in reducing depression and anxiety symptoms are many times larger than that typically seen with traditional antidepressants. In addition, psilocybin has been shown to produce a mystical experience, which patients often find to be highly meaningful and emotionally salient, followed by an “afterglow” characterized by reductions in depression and anxiety symptoms and often a positive shift in personality or perspective and feeling of greater connectedness that may last for months after a single dosing session (Majić et al., 2015).

By reconnecting people with themselves, others, nature, God, or the universe, psilocybin-assisted therapy may be uniquely suited to address psychological and existential suffering in the COVID-19 age where fear, uncertainty, and isolation prevail. In addition to potentially treating severe, complicated, and/or prolonged grief, the mystical experience triggered by psilocybin-assisted therapy may also be a potential intervention to prevent complicated grief by facilitating acceptance of the loss and enhancing the normal grieving process.

Proposed Study Focus

In response to the surge in COVID-19-related mental health and substance use disorders, we propose launching three randomized, double-blind, placebo-controlled trials of psilocybin-assisted therapy to address psychological distress in high priority populations impacted by the COVID-19 pandemic. The study will be performed at the Pacific Treatment & Research in Psychedelics clinic in Santa Monica and psilocybin will be requested from the Usona Institute. The three study groups are as follows:

Bereaved Adults
Normal grieving processes have been disrupted by COVID-19-related social distancing and quarantine requirements putting the bereaved at increased risk of complicated and prolonged grief and its complications including depression, anxiety, PTSD, and drug or alcohol abuse.

Front-line Healthcare Workers and First Responders
Extreme levels of stress due to high mortality rates among hospitalized covid-19 patients combined with fears related to inadequate PPE supplies and threat of infecting themselves and their families may put healthcare workers and first responders at the highest risk of covid-19-related mental health and substance abuse problems.

Adult COVID-19 Survivors
While hospital discharge is a major victory for patients infected with COVID-19, their families, and their healthcare providers, evidence is mounting that for some patients, especially those surviving the ICU, physical and emotional complications of their acute illness and emotional and psychological distress may linger or even last a life time.

Study Design & Timelines

In response to the surge in COVID-19-related mental health and substance use disorders, we propose launching three randomized, double-blind, placebo-controlled trials of psilocybin-assisted therapy to address psychological distress in high priority populations impacted by the COVID-19 pandemic. The study will be performed at the Pacific Treatment & Research in Psychedelics clinic in Santa Monica and psilocybin will be requested from the Usona Institute. The three study groups are as follows:

Bereaved Adults
Normal grieving processes have been disrupted by COVID-19-related social distancing and quarantine requirements putting the bereaved at increased risk of complicated and prolonged grief and its complications including depression, anxiety, PTSD, and drug or alcohol abuse.

Front-line Healthcare Workers and First Responders
Extreme levels of stress due to high mortality rates among hospitalized covid-19 patients combined with fears related to inadequate PPE supplies and threat of infecting themselves and their families may put healthcare workers and first responders at the highest risk of covid-19-related mental health and substance abuse problems.

Adult COVID-19 Survivors
While hospital discharge is a major victory for patients infected with COVID-19, their families, and their healthcare providers, evidence is mounting that for some patients, especially those surviving the ICU, physical and emotional complications of their acute illness and emotional and psychological distress may linger or even last a life time.