Psychedelic Science Conf Examines MDMA Treatment for PTSD

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Psychedelic Science Conference Examines MDMA Treatment for PTSD [FEATURE]

by Phillip Smith,
April 21, 2013


At the Multidisciplinary Association for Psychedelic Studies (MAPS) Psychedelic Science 2013 conference in Oakland this weekend there were mind-boggling displays of psychedelic art; tables full of books on LSD, MDMA, peyote, ayahuasca, and other, stranger hallucinogens; weird musical interludes; holotropic breathwork workshops, and indigenous shamans.



Psychedelic art, MAPS 2013

There was also some heavy duty science. Stretching over five days of workshops and conference presentations, the MAPS conference is perhaps the premier confab of psychedelic researchers worldwide. A look at just some of the topics covered in the remarkably broad-ranging affair makes that case.

Researchers from around the country and the world presented findings on three "tracks": clinical ("LSD-Assisted Psychotherapy in the Treatment of Anxiety Secondary to Life Threatening Illness," "The Neurobiology of Psychedelics: Implications for Mood Disorders"), interdisciplinary ("Psilocybin in the Treatment of Smoking Addiction: Psychological Mechanisms and Participant Account," "Ethical Considerations in the Medicinal Use of Psychedelics"), and a special track on the South American hallucinogenic tea, ayahuasca ("Ayahuasca Admixture Plants: An Uninvestigated Folk Pharmacopeia," "Ayahuasca, the Scientific Paradigm, and Shamanic Healing").

One series of research reports of urgent and immediate relevance centered on the use of MDMA ("ecstasy") in the treatment of Post-Traumatic Stress Disorder (PTSD). Although PTSD can be caused by any number of traumas, veterans mustering out after more than a decade of US wars in Iraq and Afghanistan are coming home with PTSD in record numbers. A 2004 study in the New England Journal of Medicine estimated that 18% of returning Iraq combat veterans had PTSD. And a 2008 RAND Corporation report estimated that up to 225,000 veterans will return from the wars with PTSD.



Dr. Michael Mithoefer describes his MDMA PTSD research protocol

The trauma of war is reflected not only in the number of vets suffering from PTSD, but even more ominously, in sky-high suicide rates. US military veterans are committing suicide at a rate of 22 per day, up 20% from just five years ago.

The military and public health workers are keenly aware of the problem, and are attempting to address it through means both conventional and unconventional. The military and the Veterans Administration have been opened to therapeutic interventions including yoga, meditation, and the use of companion dogs; they have also armed themselves with the arsenal of psychotherapeutic drugs -- anti-depressants, anti-psychotics, tranquilizers -- available in the standard pharmacopeia. But those drugs can have some nasty side effects, and their utility in treating PTSD is questionable, and, noting reports of negative consequences, the Army has warned against over reliance on them.

In a Saturday clinical track devoted to MDMA and PTSD, researchers reported on success in Phase II clinical trials (after Phase I studies had proven safety), as well as efforts to get more studies up and running, and the hoops they have to jump through to do so. Canadian researcher Andrew Feldmar perhaps best summed up professional exasperation with the complexities of doing research on drugs government view with skepticism and suspicion.

"Give me a break!" snorted Feldmar after relating how it took 2 ½ years and three visits from bureaucrats in Ottawa to inspect his pharmacy safe before it was approved before the safe and the study were approved. "This is not science, its politics. Those people from Ottawa were doing what power does -- cover its ass and make people doing what it doesn't want squirm. We are not discovering anything with these studies; we are just proving something we already know. This is all politics."



Indigenous Huichol shaman from Mexico

While Feldmar was at least able to report that his study had been approved, researchers in Australia and England could report no such luck.

Australian researcher Martin Williams reported that a randomized, double-blind Phase II study there had been stopped in its tracks by a Human Research Ethics Committee.

"The proposal was rejected by the committee with no correspondence," Williams sighed. "We submitted a comprehensive letter of appeal, and it was quickly rejected. Like MAPS in 2000, we're a bit ahead of our time for Australia, where we face war on drugs rhetoric, the psychotherapy community has more a psychopharmacology focus, and we're facing funding and regulatory hurdles."

"For the past eight years, I've been slowly trying to persuade the medical establishment this is worth doing," said British researcher Ben Sessa, who is trying to get a Phase II study off the ground there. "We have lots of war casualties because like the USA, we have a peculiar obsession with imposing democracy around the world."



Peyote-infuenced Huichol art

But his government grant was denied, with regulators saying there was insufficient proof of concept, the trial would be underpowered (because it was small), and the inclusion of patients with recreational drug histories was problematic.

"Those reasons are all rubbish," snorted Sessa, who said he was revising his protocol in hopes of it being accepted. "We went for the Rolls Royce and didn't get it; maybe we'll get the Skoda," he said.

Researchers at the University of Colorado in Boulder have gotten approval for a Phase II study of MDMA with people with chronic, treatment-resistant PTSD, but it wasn't easy, they said. Sometimes the regulatory niggling borders on the absurd, they said.

"We started two years and were waiting on approval from the DEA," said researcher Marcela Ot'alora, who is doing the study with Jim Grigsby. "We thought they read the protocol and would let us know if we were doing something inappropriate, but that wasn't the case. We had to get a 500-pound safe and we put it in the therapists' office, but no, it had to be in the treatment room. Then, we get a second inspection by the DEA, and they said we had to install alarms. We did so, and thought we were good to go. The next day, the DEA and the city zoning department came together. The zoning department said we had to have a half bath instead of a full bath, and no kitchen."



Psychedelic Homer Simpson, MAPS 2013

Ot'alora showed slides of workers obediently demolishing the bath tub, but their travails weren't finished just yet.

"The zoning department said we had to find a place zoned for addiction and recovery, and my office met that criteria, so we moved the safe and alarms for a third time, then had a third DEA inspection," she related. "The local DEA said yes, but it also needed approval from headquarters. We had a congressman write a letter to the DEA to speed up the process, and now we have final approval and are screening our first participants. We hope to enroll the first one by the beginning of May."

That would appear to be a good thing, because other researchers reported that when they actually got studies up and completed, they were seeing good results. Israeli researcher Keren Tzarfatyl and Swiss researcher Peter Oohen both reported promising preliminary results from their studies.

But it was US researchers Michael and Annie Mithoefer who reported the most impressive results. They reported on a 2004 Phase II clinical trial with veterans, firefighters, and police officers. The research subjects were given MDMA (or a placebo) and psychotherapy sessions. MDMA-assisted therapy resulted in "statistically significant" declines in PTSD as measured by standard scales, the Mithoefers reported.

"We're doing Phase II studies, giving the substance to people who are diagnosed with PTSD and measuring the treatment effects. The results continue to be extremely impressive," said Michael Mithoefer. "These tools have so much promise for healing and growth. There are lots of reasons to think these will be useful and promising tools."

Existing treatments for PTSD -- cognitive-behavioral therapies, psychodynamic psychotherapies, pharmacological interventions -- too often just don't work for large numbers of sufferers, Mithoefer said. He cited estimates of 25% to 50% who don't respond favorably to existing treatments.

"We have looming problems with veterans coming back from Iraq and Afghanistan, and most of them are not getting the treatment they need," said Mihoefer. "The Veterans Administration is overwhelmed, but also many vets just don't show up for treatment or stay in it. People with PTSD have a lot of trouble with trust, making it hard to form a therapeutic alliance. They can also either be overwhelmed by emotion and then drop out, or they are in avoidance, emotionally numb, and then the therapy doesn't work. If MDMA can increase trust and decrease fear and defensiveness, maybe it can help overcome these obstacles to successful treatment."

But even so, the research effort is starved for funds.

"This would not be happening if not for these remarkable non-profits supporting research," said Mithoefer. "The government is not funding this, Big Pharma isn't funding this; the community is funding it. We are trying to build bridges, not be a counterculture, and we hope the government will get involved."

What they've found so far is definitely worth pursuing, Mithoefer said.

"We've established that for this kind of controlled use with well-screened people, there is a favorable risk-benefit ratio and no indication of neurotoxicity," he explained, although a small numbers of participants reported unhappy side effects, such as anxiety (21%), fatigue (16%), nausea (8%), and low mood (2%).

With a follow-up three years later, the Mithoefers found that the benefits of MDMA-assisted therapy remained largely intact.

"For most people, the benefits in terms of PTSD symptoms were maintained," Mithoefer reported. "With people who completed the assessment, 88% showed a sustained benefit, and assuming that those who didn't relapsed, that's still a 74% sustained benefit."

The Midhoefers are now in the midst of another Phase II study and are finding similar results. They are finding reductions in PTSD symptoms as measured by standard measures. They are also finding lots of interest among PTSD sufferers.

"More than 400 vets have called us from around the country," said Mithoefer. "The need is so great. It's heartbreaking that we can't accommodate them all."

Anna Mithoefer read to the audience some of the responses from their research subjects.

"It's like PTSD changed my brain, and MDMA turned it back," reported a 26-year-old Iraq veteran.

"Being in Iraq was bad, but what was worse was having my body back here and part of my mind still in Iraq," said a 27-year-old who had served as a turret gunner in Iraq. "This helped me come home."

"MDMA helped me in so many ways, it feels like it is gradually rewiring my brain," said a female military sex trauma survivor. "The MDMA sessions were the crack in the ice because the trauma was so solid before that. It was incredibly intense around the MDMA sessions -- a lot like popping a big bubble from the unconscious."

The Phase II studies underway or completed strongly suggest that MDMA is useful in the treatment of PTSD. The Phase II studies trying to win approval around the world could strengthen that case -- if they can overcome the political and regulatory obstacles before them. In the meantime, another 22 veterans are killing themselves each day.


stopthedrugwar

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The Enormous Promise of Psychedelics for Sustaining Health, Happiness and Sanity


Inside this year's conference for the Multidisciplinary Association for Psychedelic Studies.



Photo Credit: MAPS

By April M. Short
April 26, 2013 |


A researcher in a suit and tie strolls past with a graduate student in rainbow leggings and a red bandana. They’re discussing smoking addiction cessation research using the drug psilocybin--the active hallucinogen isolated from the fungus Psilocybe mexicana, or "magic mushrooms.” It is the conclusion of the Psychedelic Science Conference dinner on April 20 and the pair filters with a crowd of hundreds through the exit doors of the grand ballroom in Oakland’s Marriott Hotel.

Lagging behind are Rick Doblin, founder and executive director of the Multidisciplinary Association for Psychedelic Studies (MAPS), and a gaggle of dinner attendees who hover around Doblin in hopes that they might share a few words with the man of the hour. MAPS is the non-profit research and educational organization behind the conference, and works to develop psychedelics and marijuana into legal prescription drugs.

It’s nearing midnight when the crowd finally dissipates and Doblin can be sequestered for an interview. As he speaks it becomes clear that this unprecedented conference, which brought more than 1,800 ticket-holding attendees, is the result of a labor of love into which Doblin has poured more than 20 years of his life.

“MAPS was founded based on adjusting to a major failure,” Doblin says. The year was 1982, and many psychiatrists, marriage counselors and therapists were using the not-yet-illegal substance to enhance the therapeutic process. In light of its increasing popularity, Doblin and fellow psychedelic therapists anticipated that the Drug Enforcement Administration would move to criminalize MDMA.

“I knew that there was going to be a crackdown because it was already being sold both as a therapeutic drug, and also some people were selling it as ecstasy,” he says. Ecstasy is the name given to the recreational street drug that comes in a pill-form cocktail that usually includes MDMA.

Doblin and fellow therapists formed a non-profit group called Earth Metabolic Design Laboratories (EMDL) to bolster awareness of the therapeutic use of MDMA.

The DEA had announced its intention to designate MDMA as a Schedule I substance in 1984. This categorization meant overt restriction and regulation of the drug's availability, and indicated that it had high abuse potential and held no accepted medical use. EMDL organized the scientific and medical communities to petition the DEA for a scheduling hearing in which the group argued that MDMA belonged in the Schedule III category, which would permit the continuation of MDMA’s use in psychotherapy. The decision to place MDMA in Schedule I was reached following appeals in 1988 after the DEA overruled a DEA administrative law judge's recommendation that it be placed in Schedule III.

“Once the DEA rejected that recommendation, we won in the appeals court, and then we lost, so MAPS was founded as a different kind of response, and a long-term one,” Doblin says.

Today, in addition to other psychedelics and cannabis, MAPS continues to study the healing potential of MDMA-assisted psychotherapy on psychological and emotional damage caused by sexual assault, war, violent crime, and other traumas.

The small Santa Cruz-based organization is undertaking a 10-year, $15 million plan to make MDMA into an FDA-approved prescription medicine, and is currently the only organization in the world funding clinical trials of MDMA-assisted psychotherapy. For-profit pharmaceutical companies are so far uninterested in developing MDMA into a medicine because the patent for the drug has expired, and because it is only administered a limited number of times, unlike most medications for mental illnesses, which are often taken daily for years.

Doblin says this year MAPS Psychedelic Science Conference ran more smoothly than ever.

“It’s not so much that we’ve done anything we haven't done before, but we’ve learned from what we've done before and we've done it at a higher level.”

By the looks of things inside of the Marriott, aside from unusually colorful getups, the conference could have been any number of scientific meet-ups. Researchers relayed PowerPoint presentations from their podiums to large meeting halls full of notebook-scribbling listeners, and academics roamed the halls in feverish discussion. Inside of lecture halls, the conversations were almost strictly scientific.

“We’ve had debates over whether to include policy discussions along with the science, and I would have preferred more policy, but I was wiling to let that go in order for us all to be together,” Doblin says. “I think having the community together really was the reason the conference was able to be such a success.”


Planting Seeds for Psychedelic Studies

While Doblin was intent on MAPS as a long-term means of fighting for psychedelic drug research, he says he never anticipated that it would grow the way it has.

“I had no idea how long it would take, how much it would cost, how hard it would be, and if I did maybe I wouldn't have taken this course,” he says. “So, I’m glad I wasn’t quite clear on all of tha t.... One thing I’ve learned now that I’m almost 60 is that time speeds up when you get older,” he says. “In MAPS I see all the time now seeds that were planted 20, 30 years ago that are now coming into play.”

For example, MAPS met at the Pentagon with the assistant secretary of the Navy and the Navy surgeon general to discuss their proposal to work with active duty soldiers in the treatment of post-traumatic stress disorder (PTSD).

“To my utter surprise the assistant secretary of the Navy was a classmate of mine at the Kennedy School [when I was] getting my [masters’ degree],” says Doblin. “We hadn't seen or talked to each other in 22 years but we were friends at school, and he remembered I had talked about MDMA therapy back then. So, when it came around he thought I was a trustworthy, friendly person, he saw that this was a long-term mission, and he saw it as legitimate and genuine. Those things start to happen.”

The smile on Doblin’s face as he described his perilous journey from the foundation of MAPS to this conference, which he proclaimed “an overwhelming success,” embodied a feeling that hung in the air throughout the affair. Wandering the hotel lobby and hallways during Psychedelic Science 2013 meant hearing more than one passerby exclaim that this conference harkened a renaissance in the world of psychedelic drugs.

The psychedelic science topics under study ranged from the potential uses of various psychedelic Schedule I substances to treat afflictions like heroin and smoking addiction, to the treatment of chronic illness and pain therapy at the end of life, to the moral and spiritual impacts of psychedelics on humans and society.

Three separate lecture halls were full at any given time during the conference, each dedicated to a specific theme, or track. There was a clinical track dedicated to the presentation of raw scientific and often psychiatric data, an interdisciplinary track that covered a range of lecture topics from spiritual experiences to clinical data, and an ayahuasca track.


The Ayahuasca Track

An entire track of this year’s conference was dedicated to research conducted on ayahuasca, a brew of various psychoactive decoctions prepared with the Banisteriopsis caapi vine, originally employed for spiritual and healing purposes by the people of Amazonian Peru. The vine is usually mixed with leaves containing the psychedelic compound dimethyltryptamine (DMT). The first academic discussion of the brew came from Harvard ethnobotanist Richard Evans Schultes in the early 1950s.

Among the most talked-about portions of the ayahuasca track was a lecture by Gabor Mate, a medical doctor from Vancouver, British Columbia, titled "Unlocking the Unconscious: From Cancer to Addiction." Mate has worked with psychedelic medicine among aboriginal people, as well as in contemporary, non-indigenous healing circles. He contends that therapy assisted by psychedelics, and ayahuasca in particular, can untangle complex, unconscious psychological stresses. He says these stresses underlie and contribute to all chronic medical conditions, from cancer and addiction to depression and multiple sclerosis.

In the Marriott lobby, following his lecture, Mate spoke to AlterNet on the importance of an integrative healthcare model.

“The traditional practices of aboriginal peoples, as in traditional Chinese medicine, have always assumed mind and body are inseparable,” Mate says. “That has now been validated by modern science, but modern medicine still ignores that reality. So, practices that incorporate a holistic understanding of a human being, where we don’t see the individual as separate from the environment, and we don’t see the mind as separate from the body, are essential to a complete understanding of human beings. Not as alternatives, but as part of a much more complete understanding of what it takes to heal people, and what it takes to stay healthy.”

When asked for an example Mate did not skip a beat.

“Imagine if I pulled a gun on you right now,” he says. “Your whole physiology would change. I didn't touch you, but your hormones would change, your nervous system would change, your heart rate would speed up, cortical adrenaline would be shooting out of your adrenal gland, and your brain would be in a different state.”

That is how the mind affects the body, he says.

“And that happens 24/7,” he continues. “Maybe not in such a dramatic fashion, but it happens all the time. So, in chronic illness you see the long-term effects of mind on body and vice versa, body on mind. The point is not that these are connected; you can’t separate them, they are one entity.”

While Mate is an outspoken advocate of psychedelics as one possible route to health, he says that in discussing publicly the potential benefits of psychoactive substances, it is important not to be evangelistic about it.

“We mustn't be trying to convince anybody; it is not a cause,” he says. “It’s simply a great potential modality for healthier, wholer people. We need to present the evidence for it seriously and humbly, and we have to expect that some people will be drawn to that, and some people will not be. We have to be clear that it isn’t the panacea, that we're not offering the solution to the problems of the world or the healing of every ailing person on the planet. All we are saying is here is a modality, there is a lot of research behind it, a lot of human experience behind it, why exclude it from the conversation?”


Cannabis and Conversation

Spurring conversation and communication was a theme that ran throughout the weekend. According to Doblin, organizers intentionally set up numerous opportunities for people to meet and converse.

““There’s lots of time for people to talk to each other,” he says, pointing down the hall toward the enormous indoor marketplace, where art exhibits, impromptu tea houses, holistic vendors and a musical performance/book reading stage were open until 2am.

An example of the perpetual conversation came around 3am, following the Psychedelic Science dinner on April 20, as conference-goers gathered in the “smoking area”--made up of four parking spaces in the Marriott garage converted into a cozy nook by way of Persian-style rugs, colorful hanging lamps, a couch and pillows. A circle of students, journalists and attendees engaged in a 4/20-appropriate discussion of the war on drugs and illegal substance policy in the US.

While the conference’s focus was on psychedelics rather than cannabis, it fell on the holiday that celebrates the herb, and the question of legalization was a prominent topic.

MAPS is the only organization that works to demonstrate the safety and efficacy of botanical marijuana as a prescription medicine for specific medical uses to the satisfaction of the U.S. Food and Drug Administration. So far, MAPS’ efforts to initiate medical marijuana research have been hindered by the National Institute on Drug Abuse and the DEA since their founding. For more than a decade, MAPS has been involved in legal struggles against the DEA to end this situation.

Now the nonprofit is seeking regulatory approval to conduct a study of smoked and vaporized marijuana for symptoms of PTSD in veterans of war.

Looking into the future, Doblin says MAPS would like to enroll the first police officer who has PTSD caused by work, in order to solidify the point that MDMA therapy can potentially benefit anyone. In addition, he says he plans to “hand the [Psychedelic Science] conference over to the Swiss” so that MAPS can focus on its research for a while.

“I’d also like to start an MDMA cancer study, I’d like to figure out what to do about marijuana, and I'd probably like to um—well, this conference has been so great, and volunteers and staff have done such an incredible amount of work that I’d like to get a jacuzzi for the office.”

In a timely coincidence, the Obama administration announced a change to its drug policy just two days after the MAPS conference ended. The White House spoke of a new direction in the war on drugs, in which stopping drug use before it starts and treating drug addiction as a health issue will be the new priorities. What this means for the world of psychedelic science, only time will tell.


AlterNet


April M. Short is an award-winning Bay Area journalist dedicated to social justice reporting. A lifelong storyteller, Ms. Short aims to bring underexposed legal and ethical issues into the public eye.