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MAPS-Sponsored Cancer Anxiety Research
Dr. John Halpern’s Study of MDMA-Assisted Psychotherapy in
Subjects with Anxiety Associated with Advanced-Stage Cancer
Rick Doblin, Ph.D.
OVER the last five years, MAPS has
donated over $94,000 to
Harvard Medical School-affiliated
McLean Hospital in a long-term effort to
sponsor Dr. John Halpern’s proposed
research into the use of MDMA-assisted
psychotherapy in advanced-stage cancer
patients. This MDMA-assisted psychotherapy
study is part of MAPS’ overall
strategy to become the leader in sponsoring
research into both the risks and the
benefits of MDMA (Ecstasy). In terms of
studies into the risks of Ecstasy, one fruit
of MAPS’ support of Dr. Halpern over the
years has been the initiation of the most
methodologically well-designed study of
the neurocognitive effects of MDMA, to
take place in a population of subjects who
had used Ecstasy numerous times with
minimal use of other drugs. MAPS had
brought information about and access to
this population to the attention of Dr.
Halpern and had donated in excess of
$15,000 to McLean Hospital for an initial
pilot study in these subjects. The results of
the pilot study were so promising that Dr.
Halpern applied for and received a $1.8
million, five-year grant from the National
Institute on Drug Abuse (NIDA), with the
grant application containing an
acknowledgement of MAPS’ support for
the pilot study.
On January 19, 2006, we learned that
the Drug Enforcement Administration
(DEA) had issued the necessary license for
Dr. Halpern’s study of MDMA-assisted
psychotherapy in advanced-stage cancer
patients. This meant that final regulatory
approval was in hand and the study could
begin since additional approvals had
previously been obtained in December
2004 from the Food and Drug Administration
(FDA) and prior to that from the
McLean Hospital’s Institutional Review
Board (IRB), the IRB at the Lahey Clinic
(where Dr. Todd Shuster, the oncologist
who will refer subjects to the study,
works) and the Massachusetts Department
of Public Health. Yet just when it seemed
that MAPS had achieved its long-sought
goal of starting this study, it became
necessary for MAPS to withdraw from
further direct sponsorship of Dr. Halpern’s
research and from MAPS’ parallel effort to
sponsor research at McLean Hospital into
the use of LSD and psilocybin in the
treatment of people suffering from cluster
headaches.
Immediately after DEA approval was
obtained, I learned that the McLean
Hospital administration felt that MAPS’
long-term advocacy for MDMA psychotherapy
research and general opposition to
Prohibition would cause the results of the
study to be challenged as biased if MAPS
were to sponsor the study and that they
did not want McLean to be involved in a
study funded by MAPS. Therefore, I
decided that it would be best for MAPS to
offer to withdraw from further direct
financial sponsorship of Dr. Halpern’s
research so that the study, which we had
all labored so long to start, could proceed.
Sacrifices sometimes need to be made.
Instead of funding the study, MAPS plans
to assist Dr. Halpern in contacting donors
interested in giving support directly to
McLean Hospital. We believe that this
financial distance from MAPS, and more
so the rigor of the methodological design
of the study itself, will enable the results
of the research to be viewed by skeptics
as more objective. If the results of the pilot
study are promising, MAPS will again
explore options for the support of research
at McLean Hospital. |