Healing severe trauma with MDMA

By Brandi Cowen
The Vancouver Observer

From: http://www.thevancouverobserver.com/show1369a/Healing_severe_trauma_with_MDMA

In a Swiss research lab, three-dozen doses of a drug that can give a patient the ability to discuss anxiety-provoking topics with greater ease, a sense of self-acceptance, and increased feelings of intimacy with their therapist sit untouched. The drug MDMA has already been bought and paid for, but it could be months before it reaches the people who might benefit from it.

Meanwhile in Vancouver, a rape victim experiences persistent flashbacks of her attack. One year later, she still wakes up in a cold sweat, haunted by vivid nightmares of the event. Her therapist, whom she struggles to open up to, has diagnosed her with post-traumatic stress disorder (PTSD). At her therapists suggestion, shes tried several treatments including psychotherapy and various medications but none of them have alleviated her symptoms.

Her therapist says to be patient and give the drug Paxil the latest antidepressant shes taking a chance. But shes been dutifully swallowing the pills for four months now and they havent helped. Theyre supposed to start working in three.

Sometimes, when the nightmares wake her, she goes online and researches treatments for PTSD. Shes read about something called MDMA which, when used in psychotherapy, has been successful in treating the disorder. Shes also read that her therapist cant treat her with MDMA because its a restricted substance.

MDMA is more commonly known as Ecstasy.

While the pills go untouched in the Swiss lab and the rape victim attends therapy sessions that dont seem to help, two researchers in Vancouver are preparing for a study that they hope will change everything.

Psychologist Andrew Feldmr and psychiatrist Doctor Ingrid Pacey hope to be the first Canadians ever granted a permit to import MDMA into the country for use in a clinical trial. The pair will examine the effectiveness of the drug, combined with psychotherapy, in treating PTSD.

What we are trying to show is that even a few sessions with MDMA as an adjunct to therapy will make a huge difference in lowering the scores that measure [patients] degrees of post-traumatic stress, explained Feldmr.

Antidepressants like Paxil and Zoloft dont work, he said. In fact, the people we want [for the study] are the people whove tried antidepressants and found they havent worked for them.

Feldmr and Pacey believe that MDMA, when combined with a program of psychotherapy, can succeed where antidepressants have failed. To prove it, they will treat twelve patients over a four-month period.

The study has already been given the go ahead by both Health Canada and an Institutional Review Board. The research team has started recruiting participants while it waits for Health Canada to approve the permits required to access MDMA for medical research.

The patients will all have experienced some sort of trauma such as rape, violent crime, or war that has resulted in post-traumatic stress disorder. All will have tried and failed to treat the disorder with at least one other type of therapy before participating in the study.

Eight of the patients will take a full dose of MDMA on three occasions, while the other four will get a placebo containing a very small dose of the drug. Both groups will participate in a number of therapy sessions during the study, and researchers will track the severity of their PTSD using a standard scoring system.

If we can prove that the people who get the full dose get far greater benefit than the people who get a very small dose, which is our placebo, then we will show that MDMA is effective in shortening therapy, or in making therapy more effective, Feldmr said.

Using MDMA and other psychoactive drugs for therapeutic purposes is not a new idea. In fact, hundreds of therapists were using MDMA throughout North America and Europe in the 1970s and early 1980s.

MDMA was first created in 1912 by a Merck chemist trying to create a compound that could stop excessive bleeding. Although Merck researchers periodically dabbled in MDMA research over the next few decades, it was largely forgotten by the scientific community. It wasnt until the 1970s that the drug was rediscovered and synthesized by a researcher at the University of California.

MDMA was re-discovered and designed by [Alexander] Shulgin, who was looking for an empathogen, said Feldmr. He was looking for a substance that would help people who are in therapy to really engage in therapy, to become more open-hearted with their therapist.

Thats what MDMA was actually made for. Not for raves, not for entertainment and fun. It was designed as an enhancement for psychotherapy.

MDMA Tightly Regulated

MDMA started gaining popularity as a recreational drug in the 1980s. It was particularly popular among young people attending clubs and raves because it made them feel more self-confident, improved their moods and heightened their senses.

As MDMA became increasingly mainstream, the United States Drug Enforcement Administration (DEA) moved quickly to regulate it. In 1985, the DEA classed MDMA as a Schedule I controlled substance. This classification indicates that a drug has no currently accepted medical use.

Other countries, including Canada, quickly followed the American example, classifying MDMA as a restricted substance.

Today, a growing number of mental health professionals want to see MDMA re-classified. According to Feldmr, reclassification would take MDMA off the restricted drug list and make it a prescription drug available to psychologists or psychiatrists who have training on how to use it in therapy.

But getting MDMA reclassified wont be an easy feat.

Global circulation of MDMA is currently controlled by a number of international agreements, including the United Nations Convention on Psychotropic Substances. This means there are tight restrictions on who can manufacture and sell MDMA. Worldwide, there are only a few manufacturers authorized to produce the drug. It may only be produced for research purposes.

No Canadian institutions are authorized to produce MDMA, so Feldmr and Pacey must import the drug. They have already purchased a small amount of MDMA from a licensed lab in Switzerland, but getting it to Vancouver takes time.

The research team had to apply to Health Canada for two different types of permissions in order to import the drug.

Because MDMA is a controlled substance, the Swiss manufacturer can only export it to a licensed individual or organization. Feldmr and Pacey had to ask a Vancouver-based pharmacist to apply to Health Canada for an import license. That pharmacist will receive the imported MDMA and will be responsible for dispensing the drug throughout the study.

Once the pharmacist gets the license to import, what we need is the import/export permits for the particular amount of MDMA needed for the specific study, said Rick Doblin, President of the Multidisciplinary Association for Psychedelic Studies (MAPS).

MAPS is an American-based, non-profit corporation that seeks to develop psychedelics and marijuana into legal prescription medicines for therapeutic applications. MAPS is sponsoring the study in the hopes of furthering that goal.

There has to be an import permit from Health Canada and an export permit from Swissmedic, said Doblin. Once we get that lined up, weve already got the MDMA purchased, analyzed, and sitting in Switzerland, ready to come to Canada.

Getting an import permit can be challenging. Each year, Health Canada issues only a handful of permits allowing the import of restricted drugs. In 2008, only 30 out of the 2,645 import permits issued by the department were for the import of restricted drugs.

This is [the point] where you star
t getting the police authorities involved, Doblin noted. Theyre more into the idea that weve got this system of prohibition and its based on fear. Theyre more against sometimes permitting research into the benefits of Schedule I drugs.

In spite of that, Doblin is optimistic that all the necessary permit applications will be approved.

Im hoping that its just one of those things where bureaucracy takes a long time, rather than that theres any kind of opposition, he said. Particularly with our results from the US study, its hard for people to have a rational opposition to the study.

Canadian Team Part of International Study

The Vancouver-based study is one of five that MAPS is sponsoring to investigate the effectiveness of MDMA and psychotherapy to treat PTSD. Three of the other studies, located in Switzerland, Jordan and Israel, are in various preparatory stages, while the American study was completed in September 2008.

The research teams may seem to be drawn from an unusual mix of countries, but the disparate contexts and cultures of the research locations are important.

Theres more complacency and acceptance in some other cultures, explained Doblin. You have to be willing to experience a certain amount of pain in order to get better, but if youve got this attitude that this is Gods will for you, or you deserve this somehow, going through the pain or the anger or all those things is much, much harder.

Culture isnt the only reason why having different research teams conduct the same study is important.

If its only one team, they could say that somehow its the particular pair of therapists thats doing the magic, not really the drug, Feldmr pointed out. But if there are different pairs and the results are the same, its hard to say that all the pairs are exceptional therapists.

Running similar studies in five countries may make for more convincing science, but it also makes for a more expensive project.

The total cost of all five research studies is estimated at approximately $2 million, but the cost of each individual study varies. The US study cost $1 million, while MAPS estimates that the Canadian study will cost approximately $320,000.

MAPS plans to fundraise for each individual study, rather than raising enough to cover the total price tag and then allocating the money as needed.

According to Doblin, MAPS has already secured some funding for the Vancouver-based study. He hopes that the organization will be able to raise approximately half of the remaining amount in Canada, with the other half coming from international donors.

The Way Forward

If everything goes as planned, Andrew Feldmr and Ingrid Pacey will become the first Canadians to receive permission from Health Canada to import MDMA into the country.

If that happens, a Swiss laboratory worker will package up three-dozen doses of MDMA. The package will be delivered to Vancouver, and for the first time in more than two decades, the drug will legally cross the border into Canada.

Meanwhile a rape victim will listen as her therapist describes a new, experimental treatment that may be effective in treating her post-traumatic stress disorder. She will ask for a referral to the study, hopeful that when combined with psychotherapy, MDMA will succeed where other treatments have failed.

Getting the first ever permit to import MDMA into Canada is a major milestone, but the research team hopes it will be the first of many achievements stemming from their study.

Once we prove its not dangerous, in fact its efficacious, then we would be asking for the Federal Drug Administration in the United States or Health Canada to take MDMA off the restricted drug list and make it a prescription drug available to psychologists or psychiatrists who have training on how to use it in therapy, said Feldmr.

MAPS planned MDMA/PTSD research in Vancouver, Canada led by Principal Investigators Dr. Ingrid Pacey and Andrew Feldmar is featured in this article.