Pubdate: Mon, 22 Jan 2018
Source: Globe and Mail (Canada)
Copyright: 2018 The Globe and Mail Company
Contact:  http://www.theglobeandmail.com/
Details: http://www.mapinc.org/media/168
Author: Geordon Omand
Page: A7

MDMA-ASSISTED THERAPY TRIALS TO BEGIN FINAL PHASE

Vancouver is one of 16 locations where clinicians hope to use the drug
to transform trauma treatment

Ed Thompson remembers the helplessness he felt each of the thousands
of times his twin daughters would turn blue and go lifeless in his
arms.

The young girls suffered from acute breath-holding spells, an
involuntary condition that causes children to pass out, in their case
up to 40 times a day.

"Having your kids die in your arms 7,500 times kind of sucks," he
said.

The girls' conditions eventually improved, but the experience
compounded earlier trauma Mr. Thompson had witnessed as a firefighter
in South Carolina, sending him into a spiral of post-traumatic stress,
substance abuse and thoughts of suicide.

That all changed in 2015 after Mr. Thompson enrolled in an
experimental psychotherapy trial that used clinical-grade MDMA, also
known as the party drug ecstasy, to treat patients suffering from
severe cases of post traumatic stress disorder.

Mr. Thompson said the experience saved his life and kept his family
together.

Now, researchers across North America, including British Columbia, are
gearing up for the third and final stage of trials ahead of plans to
legalize psychedelic-assisted psychotherapy in Canada and the United
States by 2021. Vancouver is one of 16 locations in the United States,
Canada and Israel where clinicians hope to demonstrate that a drug
historically associated with gurus and raves can revolutionize
psychotherapy and trauma treatment.

The B.C. Centre on Substance Use will conduct the Vancouver trials as
part of a larger research project overseen by the Multidisciplinary
Association for Psychedelic Studies, or MAPS, a non-profit
pharmaceutical company based in California. Talks are also under way
for a Montreal facility to participate.

"We hope to prove that MDMA-assisted psychotherapy is the most
effective treatment for PTSD that exists on the planet," said Mark
Haden, a public health professor at the University of British Columbia.

Prof. Haden founded the Canadian wing of MAPS and helped organize
Stage 2 of the organization's research trials in Vancouver.

Traditional PTSD treatment focuses on desensitization, which is
painful and can last years, or even a lifetime, Prof. Haden said,
adding that only about 10 per cent to 15 per cent of people
successfully recover and the drop-out rate is high.

MDMA-assisted psychotherapy, however, lasts fewer than four months and
preliminary studies show two-thirds of participants remained free of
PTSD one year after treatment, he said.

The experimental trials have been so successful, the U.S. Food and
Drug Administration, which overseas the approval and regulation of
pharmaceutical drugs, has labelled it a "breakthrough therapy" for
PTSD treatment.

Researchers believe the psychedelic drug's effectiveness is partly due
to its ability to dispel a participant's fear and to boost what Prof.
Haden called the therapeutic alliance.

"The alliance between the therapist and the subject is … the greatest
predictor of success," Prof. Haden said, describing MDMA as an
empathogen. "MDMA really, really, really increases bonding between
people."

The therapy involves three psychedelic-assisted psychotherapy sessions
lasting eight hours each, as well as 12 therapy sessions without MDMA,
which all take place over a 31⁄2 period.

Mr. Thompson, who participated in the stage two trials, said the drug
allowed him to trust his therapists and open up in a way he could not
before.

"It wasn't a party drug. There was no party," he said, as he described
lying on a futon and wearing eye shades for most of the experience.
"It wasn't trippy. I didn't see things. I didn't have some miraculous
spiritual experience. I didn't get the urge to get up and dance.

"For the first time in years I was able to open up and talk
painlessly," he said. "The fear, the barriers were removed and I was
able to talk to these people."

Rick Doblin, who founded MAPS in 1986, said one reason so little
effort has been put into researching the therapeutic benefits of
psychedelics is that pharmaceutical companies don't stand to profit
from studying compounds that are already in the public domain and
cannot be patented.

Phase three will cost $26-million and involve up to 150 study
participants. It aims to demonstrate that results obtained in the
trial's second stage are applicable on a larger scale.

Mr. Doblin said the FDA has agreed to approve the therapy if Stage 3
studies show the drug is effective and there are no safety issues.

Health Canada gave the green light for the latest round of trials, and
discussions are slated to begin in February over what the department
will need to see in order to approve the treatment.

Erika Dyck, a medical historian at the University of Saskatchewan,
said a resurgence of interest in exploring the medical usefulness of
historically maligned drugs may be linked with the ineffectiveness of
current treatments and how desperate society is to find therapies that
work.

"Think about the ways in which we accept drugs as part of our
health-care options now, and even perhaps the way that drugs dominate
our health-care options in some areas," Ms. Dyck said.

"That just wasn't really the case before. Even cancer was primarily
treated with surgery."

Canada was active in psychedelic research prior to the war on drugs,
she said, adding Saskatchewan-based psychiatrist Humphry Osmond coined
the term "psychedelic" in the mid-1950s while corresponding with
celebrated dystopian author Aldous Huxley.
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MAP posted-by: Matt