After the 1993 withdrawal of the
licenses of five members of the Swiss
Medical Association for Psycholytic
Therapy (SAePT), who practiced MDMAand
LSD-assisted
psychotherapy
for 5 years with
few restrictions,
we had to accept
that future
applications for
licenses would
be limited to the
context of
scientific
research. In
2003, the Ethics
Committee
rejected a
protocol developed by SAePT members to
investigate the efficacy of psilocybinassisted
psychotherapy in recurrent
depression.
In April 2005, my wife Verena
Widmer and I visited MAPS President
Rick Doblin, Ph.D., and MAPS-funded
researchers John Halpern, M.D., and
Michael Mithoefer, M.D., to discuss
strategies to resume research into the
therapeutic application of psychedelics in
Switzerland. This meeting soon resulted
in close cooperation between MAPS and
SAePT, and in a short time we were able
to adapt the MAPS standard protocol for
MDMA/PTSD research to our study.
The proposed pilot study will investigate
the safety and efficacy of MDMAassisted
psychotherapy in 12 patients
with treatment-resistant post-traumatic
stress disorder (PTSD), as in the ongoing
MAPS-sponsored study led by Mithoefer.
Based on the preliminary results from
Mithoefer’s study, we modified the design
to include three experimental MDMA sessions
with 125mg MDMA, followed by
a supplemental dose of 62.5mg after 2.5
hours. We also adjusted MAPS’ protocol to
use an active placebo consisting of 25mg
MDMA, followed by a supplemental dose
of 12.5mg MDMA.
As in the U.S. study, patients who
receive the placebo can choose to participate
in a second stage of the study, in
which they go through the whole process
again with a full dose of MDMA. Outcome
measures will be the CAPS (Clinician
Administered PTSD Scale) and the PDS
(Posttraumatic Stress Diagnostic Scale), a
self-report scale. Due to new findings and
the absence of neurocognitive deterioration
in MAPS’ U.S. study, we consider
these neurocognitive measures sufficient.
The protocol was submitted to the
Ethics Committee in October 2005 and
was approved on December 23, 2005. The
application is is now being reviewed by
Swissmedic (the Swiss Drug Institute).
Prior to the LSD conference in Basel,
Switzerland, the first pre-study data
monitoring visit took place at my psychiatric
practice near Solothurn, Switzerland,
where the study will be performed. During
this meeting, we set up study procedures
and Case Report Form protocol. At the
time of this writing, another data monitoring
visit is planned for early March. The
last step will be to apply for a license from
the BAG (Swiss Health Agency). We plan
to begin recruiting subjects within a few
months.
So far, the development of this study
has proceeded rapidly, without major
obstacles, thanks to the invaluable support
of MAPS. Both MAPS and SAePT have
pledged substantial contributions -
together 2/3 of the $150,000 study budget
- but further efforts will now have to be
undertaken to fund the study through
donations. The LSD conference in Basel in
honor of Albert Hofmann has helped to
bring the subject of psychedelic drugs to a
wider public audience and into the
consciousness of the medical community.
We hope that our research can be a
contribution to helping psychedelic drugs
get back to where they belong: in healing!
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