Wednesday, November 28, 2007

experimental PTSD therapy with MDMA

" ... THE CAPSULES RESIDE IN A SAFE, armed with an alarm and bolted to the floor of Mithoefer's office, a 1950s-vintage cottage on the road between downtown Charleston and Sullivans Island. It's been tastefully remodeled to create a softly lit, high-ceilinged sanctuary in the back, scattered with art and furnished with, among other things, the ever-so-slightly inclined futon where Donna got crooked.

The elaborate security is occasioned by what is inside the capsules: MDMA, a synthetic compound that is a chemical cousin to both mescaline and methamphetamine. Unabbreviated, MDMA is a real mouthful -- 3,4-methylenedioxymethamphetamine -- but it is far better known by its street name, ecstasy, millions of doses of which are synthesized in criminal labs from the oil of the sassafras plant. At one point, Mithoefer recounts, agents of the Drug Enforcement Administration, there to inspect the security arrangements, inquired about the therapist who rents the office adjoining the safe room.

"I guess they were concerned she might drill through the wall into the safe and steal the MDMA," Mithoefer says. "Though there's such a small amount in there, and it's so readily available on the street in such large quantities, I don't see how that would be worth the effort, even if she were so inclined."

Mithoefer became a psychiatrist in 1991, after a decade as an emergency room doctor -- he had found himself less interested in the bodily traumas his patients suffered than the psychological traumas that so often preceded their appearance in the emergency room. He's got that mellow, empathic vibe that they just can't teach at therapy school. He always seems moments away from a sympathetic chuckle, an understanding murmur or a sage observation. A fit 61, with a brown ponytail and relaxed dress code, Mithoefer has become the accidental point man of a movement to revive medical research into psychedelic drugs. His Food and Drug Administration-approved PTSD study that began with Donna Kilgore in April 2004 is now nearly completed, with 18 of 21 subjects having undergone the double-blind sessions. Two Iraq veterans with war-related PTSD, the study's first, are cleared to begin. Close behind are similar studies in Switzerland and Israel. At Harvard's McLean Hospital, researchers are set to evaluate MDMA therapy as a way to alleviate acute anxiety in terminal cancer patients. In Vancouver, Canada, the effectiveness of an ongoing program to treat drug addiction with another potent psychedelic drug, ibogaine, is under scrutiny. There is a proposal, based on case histories, to study the ability of LSD to defuse crippling cluster headaches.

All of these studies are directly or indirectly funded by a surprisingly robust organization whose roots stretch back 40 years to the psychedelic movement of the 1960s. Before Harvard lecturer Timothy Leary started channeling aliens and urging college kids to turn on and drop out, an intense cadre of doctors and researchers had come to believe that psychedelic drugs would revolutionize psychiatry, providing those with a wide spectrum of psychological problems -- or even just ordinary life difficulties -- the ability to, basically, heal themselves.

But Leary's bizarre career, which morphed from doing research on psychedelics to cheerleading their widespread abuse, obscured whatever medical potential the drugs may have had. Instead, authorities focused on the risks, and often exaggerated them. Richard Nixon famously called Leary "the most dangerous man in America." After a slow start, regulators and legislators cracked down hard. Millions of dollars in enforcement efforts were unable to end abuse of psychedelic drugs, but they effectively stamped out sanctioned research into their healing potential.

A small group of psychedelic researchers and therapists willing to break the law continued their work clandestinely. A much larger group did not flout the law, but waited in the wings and is now emerging. Experience had convinced these therapists that psychedelics, along with significant risks, had potential for even more significant benefits.

This may have been especially true of MDMA.

Mithoefer states the case in an article he wrote for a book of scholarly essays, Psychedelic Medicine: Social, Clinical and Legal Perspectives:"The reported results [of early therapeutic use] include decreased fear and anxiety, increased openness, trust and interpersonal closeness, improved therapeutic alliance, enhanced recall of past events with an accompanying ability to examine them with new insight, calm objectivity and compassionate self-acceptance."

In short, a therapist's dream. Or is it a hallucination?

THE PROMISE OF A BLOCKBUSTER TREATMENT, one that doesn't just address symptoms but defuses underlying causes, is a particularly seductive vision right now. A report issued last month by the National Academy of Sciences' Institute of Medicine emphasizes the uncertain effectiveness of current PTSD treatments, and the urgent need of returning soldiers who will suffer from it.

To a non-scientist, the very preliminary results of Mithoefer's study would suggest that MDMA might be just what the doctors ordered. Of the subjects who have been through both the MDMA-assisted therapy and the three-month post-experiment follow-up tests, Mithoefer reports, every one showed dramatic improvement.

But scientists are a cautious lot. "It's potentially nice to hear those things," says Scott Lilienfeld, an associate professor of psychology at Emory University. But until results are statistically analyzed and peer-reviewed for publication, "you can't really judge them. The plural of anecdote is not data." Especially with a drug that has considerable risk, Lilienfeld cautions, it pays to be skeptical.

A.C. Parrott, a psychologist at Swansea University in Britain who has devoted a large part of his career to studying the dangers of MDMA, is far more than skeptical. "MDMA is a very powerful, neurochemically messy and potentially damaging drug," he says. The government "should never have given it a license for these trials. Certainly I would not give it a license for any further trials."

But one of the nation's premier PTSD researchers, Roger K. Pitman, a professor of psychiatry at Harvard Medical School, disagrees. Morphine is a powerful, potentially damaging drug, Pitman says, "and we use it to treat the pain of cancer patients. Sound medical reasons should trump."

Current treatment for PTSD is "partial at best," he says. "There's a lot of room for improvement, and we need to be looking for novel treatments."

Though Pitman calls the MDMA study "a fringe hypothesis" -- "I've never heard anybody talk about it at any PTSD meeting I've ever attended in 25 years" -- he also observes that, based solely on a description of the preliminary results, "this seems worth further study. A lot of new ideas meet with rejection and skepticism, and we need to be careful not to be prejudiced against something just because it seems wacky. If it has a 5 percent chance, or even a 1 percent chance, of being effective in treatment of PTSD, it's worth pursuing." ... "

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