MJBizMag July 2022 - 39

wouldn't even speak to us. And it's
a multimillion-dollar-some argue
billion-dollar-path to try, " Dahmer
said.
STUDY ONE
Dahmer, who spends much of his time
networking with other physicians,
met Dr. Chinazo Cunningham at
a neurological conference. The
conversation with Cunningham, a
clinical professor at the Albert Einstein
College of Medicine and commissioner
of the New York State Office of
Addiction Services and Supports, led to
an observational clinical trial.
The study included patients
enrolled in New York's medical
marijuana program who had chronic
pain and also took opioids. The 250
patients in the study were instructed
to consume cannabis products as
they typically would and then answer
questions such as:
* What cannabis products are you
using?
* How does cannabis impact your
opioid use?
* How does cannabis impact your
pain?
These so-called " patient-reported
outcomes " provide valuable insights for
Vireo at a relatively low cost, because
they are carried out by academic
institutions that receive government
and private funding. This study, for
example, was funded by a $3.8 million
National Institutes of Health grant in
Cunningham's name. In return, Vireo
provided the products to subjects at a
substantial discount, Dahmer said.
Researchers began enrolling subjects
in the 18-month study in August
2017, and the last subjects started
in December 2021, meaning some
patients are still in mid-study.
Researchers have started to analyze
data and found that some patients
need to consume cannabis daily for
pain relief, while others' consumption
is less frequent, with factors including
individual thresholds for pain.
Vireo Health sells several medical marijuana brands at its dispensary in White Plains, New
York. Photo by Susan Magnano
" That speaks again to the complexity
not only of human beings-each one
of us are very different-but how pain
or chronic pain is a very subjective
experience. Not only is it different for
each and every one of us, but it can
fluctuate markedly even throughout
the day or throughout a week, "
Dahmer said.
STUDY TWO
After successfully undertaking the
first study, Vireo felt confident enough
to pursue the " gold standard " of
studies, a randomized, double-blind,
controlled trial.
" The patients, providers and the
pharmacists are all blinded, so they
don't know what they're getting, "
Dahmer explained.
The second study involves New
York medical marijuana patients with
chronic pain who were given softgels in
four formulations-a placebo plus three
combinations of THC and CBD.
Study administrators aim to enroll
250 patients; through late May, they had
enrolled about 80. Patients are enrolled
for 14 weeks in the study, which is being
funded by a private grant.
" The beauty of a randomized control
trial is that the time period is much
shorter, " Dahmer said.
While the first study was purely
observational, researchers and Vireo
officials haven't ruled out the prospect
of a cannabis-based drug with FDA
approval.
" We're already testing the waters,
looking at three of our different
products versus placebo, backing
that up with longitudinal data to
try to determine: Of the many SKUs
and products that we offer in the
market, is there one that does better
and that supports patients more in
their diagnosis of chronic pain and ...
decreasing opioid use? " Dahmer said.
The doctor noted the research team
has submitted a pre-Investigational
New Drug (IND) application-an early
step that companies must take if they
intend to conduct FDA-approved
studies that could lead to FDAapproved
drugs.
Vireo is now waiting to see which of
the products it is testing offers the best
results and which has the best chance
of making it through the FDA process,
Dahmer said.
Dahmer noted that when companies
file an IND for a pharmaceutical
product, it's usually for a " single
constituent. "
" If you file and receive an IND, you're
moving through that FDA process, "
Dahmer said. " So you'd better be very
certain that the product you choose to
push down that pipeline is one that you
hope will have success. "
mjbizdaily.com | July 2022 39

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