The initial results of the drug-assisted psychotherapy project have been positive.
Cover photo via Flickr
This story first appeared on VICE Quebec.
The use of MDMA in the treatment of post-traumatic stress disorder (PTSD) may soon be one step closer to legalization in Canada. Montreal has been selected as a research site for clinical trials on drug-assisted psychotherapy, according to the Multidisciplinary Association of Psychedelic Studies (MAPS), which is overseeing the research. The final step that could lead to the legal use of MDMA in a medical context.
"We are going to have two research sites in Canada," says MAPS Director of Strategic Communications Brad Burge. "Montreal will be led by Dr. Simon Amar. But we still can not confirm who will lead Vancouver. "
The study, which will take place in Dr. Amar's private clinic could be launched as early as the end of the year or the beginning of 2018. MAPS tells VICE it received a letter from Health Canada indicating it doesn't object to the research, though the federal agency wouldn't confirm as much since talks are ongoing.
This new large-scale study is intended to confirm the findings of the phase two trials that got started in 2013 in Vancouver under the leadership of Dr. Ingrid Pacey of the Addictions Research Center of British Columbia. In all, about 100 people with PTSD participated in the MAPS-led clinical trials in Canada, the United States, Israel, Spain and Switzerland.
In British Columbia, six patients ingested 125 milligrams of MDMA or placebo and then participated in eight-hour psychotherapy. The patients then repeated the experience once more, taking only amphetamine.
The phase three study in Montreal is a final step before doctors can start legally prescribing MDMA to patients suffering from PTSD.
The spectre of the MKUltra Project
MAPS, a California-based non-profit organization that advocates for greater access to psychedelic drugs and cannabis, for both recreational and therapeutic use, initially wanted to conduct its research at McGill University, but the leadership of the university refused.
The institution has a symbolic place in the history of psychedelic studies. Between 1956 and 1963, Dr. Ewen Cameron performed "deprogramming" treatments at the Allan Memorial Institute in Montreal, which houses the department of psychiatry at the hospital and the McGill University Health Center. He used LSD and electroshock for the development of brainwashing techniques. Patients were subjected to long periods of induced sleep during which they had to listen to the same sounds over and over again..
The Cold War-era study was funded by the CIA and was part of the MKUltra project. It was not until 1992 that the Canadian government agreed to compensate some of Dr. Cameron's victims. CBC revealed recently that Ottawa agreed to pay $100,000 to the daughter of a woman who underwent Dr. Cameron's brainwashing experiments 60 years ago.
According to MAPS founder Rick Doblin, a long-time advocate for the use of psychedelics in a medical setting, the history of the Allan Memorial Institute has been a traumatic one for the entire medical community.
"That's the reason why there has not been any research in Montreal since 1963," he says. "The city is very symbolic since it was at McGill that the worst practices of the CIA with psychedelic drugs took place. Successfully completing this study with MDMA in Montreal contributes to a renaissance of this branch of medicine."
Phase two was a great success
VICE also learned that on October 4, Health Canada approved the results of the second phase of clinical trials on drug-assisted psychotherapy, which took place in Vancouver.
The data, which should soon be made public by Health Canada, are impressive.
"Our PTSD treatments have been 66% effective in three months. Traditional treatments for PTSD are relatively ineffective, ranging from 10 to 25% success according to the studies, and they are spread over years," said MAPS Canada Executive Director Mark Haden, who is also an associate professor at the UBC School of Population and Public Health.
While MAPS is pleased with Health Canada's approval of the results, the top priority today is to be able to launch phase three in Canada.
"We're talking to Health Canada, and it's going very well," says Haden. "Ultimately, we want to be able to prescribe MDMA to certain patients undergoing psychotherapy."
MDMA treatments are also under study in the United States
In August, the Food and Drug Administration, the US drug approval agency, described the use of MDMA on PTSD patients as "Breakthrough Therapy" and endorsed two phase three studies, provided MAPS can secure the approximately 25 million US dollars necessary to conduct them. All of the association's funding comes from donations from the public. This research could be launched this spring and continue until 2021.
On the Canadian side, there are a few more steps to complete before this final phase of the research. "Section 56 of the Controlled Drugs and Substances Act allows for research exemptions, and that's what the government is asking for," said Mark Haden. "And we need a license to import MDMA. We must also install a vault to store it, which will have to be inspected by Health Canada. There is still a lot to do. "
MAPS Canada also launched a petition last month asking Federal Health Minister Ginette Petitpas Taylor to recognize that "research on psychedelic substances [including MDMA] is generating new and effective treatments." The organization wants it to commit significant funding for research projects.
There is a fringe community that uses MDMA as part of artisanal therapy sessions, which may have be helpful some according to Mark Haden. But the use of street ecstasy in a recreational setting is not therapeutic.
"The criteria for participating in our studies are very strict," he says. "We work with people who have serious problems and who have been experiencing chronic post-traumatic shock for years. "
MDMA, or 3,4-methylenedioxy-methamphetamine, is an empathogen, which means that it generates empathy and trust among its users. The drug reduces activity in the amygdala, the part of the brain that treats fear. It also stimulates the production of oxytocin and prolactin, hormones that make people more loving, peaceful and connected. They are released naturally during childbirth, or during orgasm, among others.
"When a person experiences post-traumatic shock, they can not control the images that come their way," says MAPS founder Rick Doblin. "Every day, the person sees things that remind him of traumatic events. As a result of MDMA, the patient can more easily retrace his memories and separate the past from the present. It is through the reconsolidation of memories in a safe context that people are able to detach themselves from their fears. "
Rick Doblin discovered the properties of the MDMA in 1982, while it was still legal and in use in a therapeutic capacity.But the substance, also known as ecstasy, became popular in recreational settings and was banned in 1985, in the wake of President Ronald Reagan's war on drugs in the United States.
Doblin admits that his fight for the therapeutic approach hides another aimed at legalizing MDMA in a recreational setting.
"Our strategy is to end the war on drugs and build a healthier society," he says. "We recognize that the medicalization of drugs is a first step towards full legalization. As with cannabis, by doing medical research, we show the public that drugs are less dangerous than any propaganda has made us believe."
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