MAPS: MDMA/Ecstasy healing PTSD

From MAPS, reprinted with permission:

<< MAPS (Multidisciplinary Association for Psychedelic Studies) is a 501(c)(3) nonprofit research and educational organization. Its mission is (1) to treat conditions for which conventional medicines provide limited relief—such as posttraumatic stress disorder (PTSD), pain, drug dependence, and anxiety and depression associated with end-of-life issues—by developing psychedelics and marijuana into prescription medicines; (2) to treat many thousands of people by building a network of clinics where treatments can be provided; and (3) to educate the public honestly about the risks and benefits of psychedelics and marijuana.>>

As increasingly more U.S. soldiers return home with posttraumatic stress disorder (PTSD) after serving in Iraq and Afghanistan, it’s our national priority and ethical obligation to develop more effective treatments for PTSD. MAPS is responding by conducting a series of Phase 2 pilot studies in order to demonstrate to the public and regulatory agencies that MDMA-assisted psychotherapy can be used as a remarkably effective medical treatment for chronic, treatment-resistant PTSD patients who are inadequately helped by currently available treatments. On July 19, 2010, the results of our first Phase 2 pilot study were published in the Journal of Psychopharmacology; of 20 subjects in the study, over 80% no longer met the diagnostic criteria for PTSD, compared with 25% in the placebo group.

In 2009, the U.S. Veterans Administration spent about $5.5 billion on PTSD disability payments to approximately 275,000 veterans, with costs and numbers of veterans with PTSD continuing to increase. During an appearance at a gathering of mental health professionals on October 26, 2009, U.S. Secretary of Defense Robert Gates stated, “Beyond waging the wars we are in, treatment of our wounded, their continuing care, and eventual reintegration into everyday life is my highest priority…I consider this a solemn pact between those who have suffered and the nation that owes them its eternal gratitude.”

“It’s basically like years of therapy in two or three hours. You can’t understand it until you’ve experienced it.” – former Army Ranger who participated in a MAPS-sponsored pilot study, quoted in Military.com, March 2009

The primary reason for selecting MDMA as our initial drug target is that it offers patients a unique, gentle, yet profound experience of self-acceptance and an enhanced ability to feel and integrate complex, challenging emotions. Compared to other psychedelics like LSD or psilocybin, MDMA provokes minimal effect on perception or one’s sense of self-control. This makes MDMA a suitable drug to administer to psychedelic-naïve patients as well as to therapists in training to administer MDMA-assisted psychotherapy.

Another major reason for working initially with MDMA is that over the last 25 years, the nations of the world have spent over $300 million on basic research into the risks of MDMA/Ecstasy, with all of that research in the public domain. A search on Medline for the terms MDMA or Ecstasy results in over 3625 published papers. As a result of the enormity of the existing body of research, the funding necessary for our drug development program is drastically reduced, since we do not have to repeat these basic safety studies. Concerns about toxicity have decreased over the past decade due to this body of research. Toxicity concerns are further minimized in our therapeutic model because MDMA is administered only a few times within a three to four month period of therapy, and only under the direct supervision of a therapist team (we require male/female co-therapist teams). This is in contrast to existing medications, which are administered daily for months, years, or often indefinitely.

PTSD is our top priority clinical indication in large part because MDMA possesses unique pharmacological and psychological properties that may make it especially well suited for use as an adjunct to psychotherapy with PTSD patients. In addition, PTSD is a worldwide public health problem and is typically a chronic illness associated with high rates of psychiatric and medical co-morbidity, disability, suffering, and suicide. An array of psychotherapeutic options exist for treating PTSD and two SSRIs (sertraline and paroxetine) are approved as PTSD treatments by the FDA. However, a significant minority of PTSD patients fail to respond adequately to established PTSD psychotherapies, or respond in ways that are statistically significant but clinically inadequate. The existing evidence demonstrates that the combination of pharmacotherapy and psychotherapy is more effective in treating PTSD than either pharmacotherapy or psychotherapy alone. Once approved, MDMA will be the first medication that works by enhancing the psychotherapeutic process, unlike other pharmacotherapy treatments that are administered on a daily basis primarily to reduce symptoms.

Q: What is MDMA?
A: MDMA is a unique medication that we believe has the potential to enhance the psychotherapeutic process. It is currently classified as a Schedule I substance, which means that it can be legally administered to humans only in the context of a research study. MAPS’ goal is to sponsor rigorous research that proves safety and efficacy to the satisfaction of the FDA so that MDMA-assisted psychotherapy can become legally prescribed.

Because of MDMA’s reported ability to decrease levels of fear and defensiveness and increase the sense of trust, we hope that will be a catalyst for the therapeutic process.” – Michael Mithoefer, M.D., MAPS-sponsored therapist, quoted in The Washington Post, March 2004

Peter Oehen, a psychiatrist in the Swiss town of Biberist, says substances such as MDMA can produce results where conventional psychotherapies fail. “They help overcome the wall of denial  that some patients build up,” said Oehen. – USA Today, April 2008

“Patients in our study had a fear of the fear. Something about the MDMA made it possible for them to approach the feared thought, the feared ‘place’ in their mind–and when they got there, it wasn’t as terrible as they thought. A lot of these people, the light bulb went off, they had the insight, but there’s still a lot of work to do. They’ve had this for years, it’s shaped their lives, and now they have to rebuild them.” – Mark Wagner, Ph.D., MDMA/PTSD study independent rater, quoted in The Washington Post, November 2007

Before becoming the first patient treated by Michael and Annie Mithoefer in the flagship MDMA-assisted therapy study sponsored by MAPS, Donna Kilgore had been suffering from posttraumatic stress disorder for over ten years. Donna had been the victim of a brutal rape in her home in 1994. For years she experienced some of the symptoms of PTSD, including nightmares and an even more frightening sense of numbness towards her life and family. “It was what it must feel like to have no soul,” she says. It wasn’t until her symptoms escalated to flashbacks, panic attacks, fainting spells and migraine headaches that she sought treatment and was quickly diagnosed with post-traumatic stress disorder. She followed a regimen of various antidepressants and tried dozens of different therapists and forms of therapies, but nothing worked. “I was getting to the point where it was either go sit on a mountaintop or go dive off a cliff.” That was until she tried MDMA-assisted therapy.

“Before, I knew the path was through the battlefield, but I just could not get through it. [But during MDMA therapy] I knew I could walk through it, and I wasn’t afraid.”– Donna

 

Reprinted with permission: http://www.maps.org/home/