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 At least a dozen subjects with life-threatening diseases like
cancer, and who are expected to live at least 9 months, will
participate in the double-blind trial over the next year in Santa
Cruz, said Brad Burge, spokesman for the Multidisciplinary
Association for Psychedelic Studies, in Santa Cruz.
Each subject will be randomly given either a full dose - 125
milligrams of MDMA, or an "active placebo" dose of 30 milligrams,
Burge said.
Burge said the goal is to test whether gravely ill patients
suffering from debilitating anxiety, fear or depression due to their
diagnoses can find a measure of peace during the extended
ecstasy-influenced psychotherapy sessions.
The trial's principal investigator, Dr. Philip Wolfson, told the San
Francisco Chronicle newspaper that the MDMA experience, lasting four
or five hours, can be "transformationally potent" under controlled
settings with a pair of trained therapists.
"It's a substance that supports deep, meaningful and rapidly
effective psychotherapy," Wolfson told the Chronicle.
MDMA is a psychoactive drug that has been banned under federal law
for decades.
While the Drug Enforcement Administration declined to comment, Burge
said the federal agency has certified the security infrastructure of
the clinic.
The Food and Drug Administration said U.S. law and FDA regulations
prohibit the agency from disclosing information about drugs that are
being developed and studied, said spokeswoman Sandy Walsh.
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Results were expected within 12 to 15 months.
"Our hypothesis is that something is happening with MDMA that makes
psychotherapy easier," Burge said.
"So with a lower dose of MDMA in the active placebo, it might fool
the subject or the therapist. And by giving people the option of
following up with another half dose, it just extends the window for
therapy rather than making it more intense."
Those receiving the full dose have an option later to take another
62.5 milligram dose as part of the same session, and those receiving
the placebo can later re-enter the trial, he said.
(Reporting by Emmett Berg in San Francisco; Editing by Michael
Perry)
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