Preprint
V3.
0
A
R
oadmap
for
P
sychedelic
S
cience
2
Abstract
Research in the last decade has expressed considerable optimism about the clinical potential
of
psychedelics for the treatment of mental disorders. This optimism is reflected in a
n
increase in research papers, investments by pharmaceutical companies, patents, media
coverage, as well as political and legislative changes. However, psychedelic science i
s facing
serious challenges that threaten the validity of core findings and raise doubt regarding clinical
efficacy and safety.
In
this paper, we introduce the 10 most pressing challenges, grouped into
easy, moderate, and hard problems. We show how these p
roblems threaten internal validity
(treatment effects are due to factors unrelated to the treatment), external validity (lack of
generalizability), construct validity (unclear working mechanism)
or
statistical conclusion
validity (conclusions do not follow
from the data and methods). These problems tend to co
-
occur in psychedelic studies, limiting conclusions that can be drawn about the safety and
efficacy of psychedelic therapy. We provide a roadmap for tackling these challenges and share
a checklist that
researchers, journalists, funders, policy makers, and other stakeholders can
use to assess the quality of psychedelic science. Addressing today’s problems is necessary to
find out whether the optimism regarding the
therapeutic
potential of psychedelics has
been
warranted
and to avoid history repeating
itself
.
Keywords:
Psychedelics; Validity; Questionable Research Practices; Open Science;
Psychotherapy