This is an announcement for people living in the Bay Area who are interested in learning about a new and potentially effective drug+therapy for PTSD. Tomorrow (Thursday) evening Michael Mithoefer, M.D., will be presenting results from FDA-approved Phase 2 Clinical Trials, including an update to his current study of Iraq & Afghanistan war veterans suffering from PTSD.
MDMA-Assisted Psychotherapy for PTSD: Research, Results, and Potential
Thursday, May 31, 2012
7:00 PM – 8:30 PM
Reception Follows
University of California, San Francisco
Medical Center Health Sciences West, Room 300
505 Parnassus Avenue, San Francisco
Directions/Parking
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For background info see below.
Here is a little more information about why I think this research is so important.
According to the VA, combat-related PTSD occurs in 11-20% of Veterans of Iraq/Afghanistan, 10% from the first Gulf War and 30% of Vietnam vets. PTSD can also be caused by Military Sexual Trauma (which they define as sexual harassment or sexual assault). 23% of women soldiers report sexual assault and more than half (55%) of women and a third (38%) of men have experienced sexual harassment in the military. Not all of them develop PTSD. But Jeebus! This all adds up to a lot of anguish and suffering. Not to mention the ripple effects on families and loved ones.
In the general US population there is also a high incidence of PTSD due to rape, child abuse, and other violent situations. 10% of women and 5% of men will develop PTSD at some point in their lifetime. (from VA source linked above)
The effects are long-lasting and currently available treatments are often ineffective or mask symptoms without providing long-term resolution of the deep psychological trauma.
The doctor who will be presenting the lecture will show that MDMA, administered once, in combination with a dozen talk therapy sessions can lead to long term reduction in PTSD symptoms -- because MDMA helps the patients to confront and conquer the underlying fear of their particular situation. The first study, published by Mithoefer in 2010 (J. Psychopharmacology (PDF), included 20 participants with chronic, treatment-resistant PTSD. 80% percent of the participants who received MDMA-assisted psychotherapy no longer rated a diagnosis of PTSD, compared to 25% from the placebo group. The benefits were confirmed with long-term follow-up (3.5 years on average). As mentioned previously, a second study is underway with Iraq/Afghanistan vets who have PTSD. Once these studies are completed the findings will be reported to the FDA and they will seek approval for Phase 3 trials, where thousands more subjects will be tested for MDMA's therapeutic effects.
Phase 3 is expected to take 10 years and cost $10 million. The National Institutes of Health (NIDA in particular, with the help of the DEA) have thrown up roadblocks to legitimate research at every turn for decades - or ever since these drugs were put on Schedule 1. Hence, they have absolutely no interest to fund any of this research. Likewise, the pharmaceutical companies stand to make no profits from a drug whose patent expired ages ago, so they aren't going to bother with clinical trials either. In 2009, the VA spent about $5.5 billion on PTSD disability payments to 275,000 veterans. These costs will only continue to increase. So one would think they'd want to make some investment in finding a solution. A few million is a drop in the bucket for them. Hopefully this research will spur them to get on board.
Meanwhile, the Multidisciplinary Association for Psychedelic Studies (MAPS) is raising all of the funding for this research from private donors and foundations. Their budget for the MDMA/PSTD project up to 2013 is shown below. I disclose that I have a membership, attend their conferences and make additional donations because I believe this (and the other work they support) is so important and I know that they are doing it for the right reasons.
Source: Prospectus (PDF). Click to enlarge.
They are also funding training for therapists so that when the Phase 3 clinical trials expand they will have the right people in place to administer the treatment based on a very specific protocol (see Treatment Manual).
Finally, in the coming years, they are going to begin recruiting volunteers to participate in Phase 3 placebo-controlled studies. In fact, it looks like they are still looking for subjects for the current study.
I plan to attend the lecture and will give an update when I get the time - hopefully sometime over the weekend. I also plan to write more about the specifics of the research and how it compares to existing treatments. I'm a pharmacologist by training, with a good grasp of psychology, but no professional experience in the latter. I am also no longer in a science career but am an advocate of psychedelic research.