By John H. Halpern, M.D.
Assistant Director
Alcohol and Drug Abuse Research Center,
Harvard Medical School/McLean Hospital
As MAPS members are probably well aware, our
projects are finally drawing a considerable amount of
publicity. Even as I typed this first sentence, a reporter
from the L.A. Times called to talk about the resurgence of
interest in research of psychedelics! She must have been
referring only to media interest, as MAPS efforts are
longstanding. All this attention is justified: we truly are
on the cusp of commencing research at Harvard. The first
project will be to enroll 12 subjects with advanced-stage
cancer, a prognosis of less than 12 months of life remaining, and who have a diagnosis-associated anxiety disorder
that is not sufficiently improving with standard treatments/medications. All subjects will receive six non-drug
psychotherapy sessions and up to two MDMA-mediated
treatment sessions, two to three weeks apart.
Eight enrolled subjects will be randomly assigned to a full test-dose group and the other four will be assigned to the control group. The full test-dose of MDMA in session one is 83.3 mg followed 2.5 hours later by 41.7 mg (125 mg total) and, in session two, 125 mg followed 2.5 hours later by 62.5 mg (187.5 mg total). Those subjects assigned to the control group will receive 25 mg followed 2.5
hours later by 12.5 mg (37.5 mg total). This is too small a dose to be considered fully
psychoactive but should be enough MDMA to serve as a psychoactive placebo. All doses are divided such that the first 2/3rds are administered first and then the final 1/3 is given 2.5 hours later if all parties agree and we believe it remains safe to do so. By splitting the dose of MDMA this way, we will evaluate whether extending the MDMA experience can deepen the therapeutic work.
Thanks to you all for your dedication to making it
possible for my collaborators and me to do what
some would have thought impossible.
In the months following these sessions, we will be collecting data on continued use of medications for anxiety
and pain while continuing to assess how much the experimental treatments may have impacted anxiety and quality
of life measures. The MDMA/Cancer study now awaits
only our DEA Schedule I registration so that we may
prescribe MDMA. We already have Schedule I registration
from the Massachusetts Department of Public Health, and,
once the DEA registration is issued, we will be ordering 3.25 grams of MDMA. Also, suitable facilities for this
project have finally been arranged for us here at McLean
Hospital. The space is in a modern building that has large
skylights in the treatment room.
Members of the research team have already met with
Ms. Amy Emerson, who provides us with the clinical
research monitoring procedures to ensure that we gather
our data in a professional manner. Ms. Emerson is currently providing these services for Dr. Mithoefer's MDMA/PTSD study in South Carolina. Dr. Umadevi Naidoo, my
co-therapist, will visit Michael and Ann Mithoefer soon
to observe a treatment session and to discuss special issues
that may arise when MDMA is administered in a research
setting. We estimate that our study will be enrolling
cancer patients within the next two to three months! To
read more or to find out the latest breaking news related
to the study, please go to the MAPS website.
Another extremely exciting project at McLean Hospital
is described on page 18 of this Bulletin. Dr. Andrew Sewell,
my lab's first post-doctoral fellow, details our progress on
studying how LSD and psilocybin may offer significant
relief for people who live with the devastating chronic
illness of cluster headaches. Very few physicians have
completed residencies
in psychiatry as well
as neurology, so we are
quite fortunate that Dr.
Sewell has agreed to
forgo the lucrative draw
of private practice in
favor of collaborating
with us. If we do activate
a study in which LSD is administered to these headache
sufferers, someone with Dr. Sewell's unique training
should prove essential in study design, implementation,
and in that ever-important issue of convincing all those
powers that be that, just like in the MDMA/Cancer study,
we have brought together an exemplary team to conduct
this work. After publication of our case series describing
what current cluster headache sufferers have found from
their personal experimentation with LSD or psilocybin
(we have medical records on more than 30 patients so
far!), we will be drafting all the documents needed for
an eventual controlled study, just like we've achieved for
the MDMA/Cancer project. If all goes as planned, MAPS
could soon be sponsoring the only clinical research project
with LSD in the world! And wouldn't that be a remarkable
surprise if it occurs during Dr. Albert Hofmanns 100th
birthday year in 2006? Stay tuned and please continue
to check the MAPS website for further developments as
they occur. Many years of hard work are starting to realize
some of MAPS most important missions for competent and
thorough research. Thanks to you all for your dedication to
making it possible for my collaborators and me to do what
those of lesser vision would have thought impossible.
Thanks to you all for your dedication to making it
possible for my collaborators and me to do what
some would have thought impossible.
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