Psilocybin for End -Of-Life - Therapsil

Psilocybin for End - Of- L ife

Psiloc ybin is a c lassic serotonergic psyc hedelic drug and is the primary psyc hoac tive
c ompound in magic mushrooms. Psyc hedelic drug’s therapeutic potential were first
investigated in the 1960s in numerous c linic al studies but unfortunately, by the 1970s,
c linic al researc h with psyc hedelic s was almost fully terminated and we are still
experienc ing the reperc ussions of this today. However, before that freeze out, studies
into psyc hedelic s pointed to a potential role for psiloc ybin and other c lassic
psyc hedelic s in c anc er- assoc iated or end- of- life–assoc iated psyc hologic al distress
(R eic he et al., 2018; R oss, 20 18). R ec ently, after a long hiatus period of regulatory
obstac les, interest in the c linic al use of psiloc ybin for this patient population has
resumed (George et al., 2020).

Individuals who have been diagnosed with a terminal illness may not only have physic al
suffering, but also signific ant emotional, spiritual, and soc ial distress (S teinhauser et al.,
2000). Anxiety and depression are some of the most c ommon psyc hiatric symptoms of
patients suffering with life threatening diseases, often assoc iated with a low quality of
life and a poor overall prognosis (R eic he et al., 2018). However, there are c urrently no
pharmac ologic interventions for existential distress (B ogensc hutz and R oss, 2018) and
available pharmac ologic treatments for depressive symptoms in patients with c anc er
have not demonstrated superiority over plac ebo (Ostuzzi et al., 2018). T herefore, there
remains a need for additional effec tive treatments for those c onditions.

T oday, there is a growing body of data has linked psiloc ybin- assisted psyc hotherapy
with improved existential and spiritual well- being in patients with a terminal illness as
well as improved quality- of life in the fac e of death, dec reased depression, dec reased
hopelessness, dec reased desire for hastened death, and inc reased gratitude gratitude
(B reitbart et al., 2000, 2010; Mc C lain et al., 200 3; N elson et al., 2002).

Present day c linic al researc h with psyc hedelic s involves a drug- assisted psyc hotherapy
paradigm and psiloc ybin- assisted psyc hotherapy refers to the professionally guided use
of psiloc ybin in c ombination with psyc hotherapy and differs greatly from the rec reational
use of psyc hedelic s. In psiloc ybin- assisted psyc hotherapy, partic ipants undergo just one
or a small number of psiloc ybin sessions intended to produc e a profound and temporary
alteration of c onsc iousness. “S et and setting”—a term whic h refers to the psyc hologic al,
soc ial, and c ultural parameters whic h shape the response to psyc hedelic drugs, is highly
influenc ed by fac tors suc h as expec tanc y, preparation, and intention (set), and physic al
or soc ial environments (setting) (Hartogsohn, 2017) and are c arefully managed by
preparatory non- drug sessions and the c reation of a safe, c omfortable spac e for
partic ipants during drug treatment sessions. T he presenc e of trained guides during drug
treatment sessions is c onsidered key, as are post- treatment non- drug integration
sessions sessions (R osenbaum et al., 2019).

Randomized control trials utilizing psilocybin - assisted psyc hotherapy to treat
psyc hologic al and existential distress assoc iated with advanc ed or terminal c ancer have
resumed within the last 2 dec ades at the U niversity of C alifornia L os Angeles (U C L A),
J ohns Hopkins U niversity and N ew Y ork U niversity L angone Medic al C enter and have
produc ed very promising results.

T wo of the most rec ent studies with patients with life- threatening c anc ers as well as a
range of psyc hiatric disorders in the mood and anxiety realms from J ohns Hopkins
U niversity (Griffiths et al., 2016) and N ew Y ork U niversity (N Y U ) (R oss et al., 2016) have
been very influential in the revival of psyc hedelic researc h. T he J ohns Hopkins U niversity
study inc luded 51 patients and used a c rossover design whereby eac h patient rec eived
both an experimental high dose of psiloc ybin and a low dose that served as an ac tive
plac ebo c ontrol. T he N Y U trial inc luded 29 patients randomized to rec eive psiloc ybin or
the ac tive plac ebo niac in in a c rossover design involving 1 drug session eac h. B oth trials
involved preparatory and post- treatment integration psyc hotherapy sessions,

B oth studies demonstrated powerful, immediate, and lasting benefits based on
standardized measures of anxiety and depression. F urthermore, both studies
demonstrated a similarly robust safety profile of the experimental intervention in a
medic ally ill population, with no serious adverse medic al or psyc hologic al outc omes
reported in either study . T hese findings are c onsistent with published work about the
safety and risk profile of psyc hedelic s, whic h can be appropriately mitigated both with
c areful sc reening of subjec ts who have an underlying risk of psyc hosis and with
appropriate support by the psyc hotherapy team . (Gasser et al., 2014; Griffiths et al., 2016;
Grob et al., 2011; R oss et al., 2016). T here are also now positive preliminary reports on the
safety and tolerability of psiloc ybin for c linic al conditions suc h as obsessive c ompulsive
disorder (Moreno et al., 2006) alc ohol use disorders (B ogensc hutz et al., 2015) tobac c o
addic tion (J ohnson et al., 2014) and for major depressive disorder (C arhart- Harris et al.,
2021, 20 16, 2012)

T hese milestone studies from J ohns Hopkins U niversity and N Y U also suggested a
c entral role of the psiloc ybin- oc c asioned mystic al- type experienc e, whic h c orrelated
signific antly with therapeutic outc omes based on ratings using validated sc ales.
Additionally, qualitative researc h from the N Y U trial revealed several key themes
identified by partic ipants in their follow up psyc hotherapy sessions: rec onc iliation with
death, ac knowledgment of c anc er’s plac e in life, and emotional unc oupling from c anc er
(S wift et al., 2017). Indeed, partic ipants reported that the psiloc ybin therapy helped them
to rec onnec t to life, rec laim presenc e, and inc rease their c onfidenc e in the fac e of
c anc er rec urrenc e.

These reports are also consistent with patient testimonials who have been treated with
psiloc ybin for their end- of- life distress through T heraPsil. T homas was one of the first
patients to rec eive a legal exemption through T heraPsil and when asked how his
perspec tive on life c hanged after his psiloc ybin treatment he says “It's really been very
foreign for me dealing with this whole c onc ept of anxiety. It's not a natural state for me.
F or some people, they deal with anxiety on a daily basis for years on end, and I just
haven't had to deal with that. And as a result, I didn't really have a lot of good tools in my
toolbox for dealing with that. Having the psiloc ybin has given me the c hanc e to
experienc e c onsc iousness in a form that is ‘other’ from the way that I normally
experienc ed it. [It] was a way of showing me that there are other elements to our reality
and our existenc e that we're not aware of. And that perhaps the transition from living to
not living could be as simple as the transition from waking to sleep. It's very c omforting
for me.”

In c onc lusion, there is now substantial evidenc e that psiloc ybin- assisted psyc hotherapy
is effec tive in the treatment of mental health issues in patients with a life- threatening
disease and is well tolerated. Moreover, there is c lear evidenc e that psyc hedelic-
induc ed mystic al- type peak experienc es mediate not only reduc tion of psyc hiatric
symptoms in these patients but may also be helpful for these patients by improving
disease c oping and quality of life when fac ing a life- threatening c ondition. As more
patients in palliative c are report feeling uplifted, c onnec ted and hopeful a result of
psiloc ybin- assisted psyc hotherapy and given the safety profile of psiloc ybin, this form of
treatment is a very promising option– espec ially for patients where other approac hes
have been ineffec tive.

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