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Transcendental Medication

cover01A look inside the local nonprofit that has set out to prove psychedelic drugs like ecstasy and LSD can help restore mental health. Do the benefits outweigh the dangers?
The notion of psychedelic substances having medicinal or therapeutic value is far from new: For centuries, indigenous people have been chewing psychoactive cactus flesh as a cure for such ailments as toothache, fever and skin disease. And since at least as far back as the mid-19th century, members of tribes throughout the Amazon Basin have been drinking the mind-altering brew ayahuasca and purging themselves of longtime mental, emotional and physical ills. However, for modern-day Americans raised on horror stories of kids being carried off the dance floor on stretchers or plummeting to their deaths while trying to fly, such a concept can be hard to swallow. Alternately, if the mention of drugs like LSD, ecstasy and psilocybin mushrooms fills your head with images of people named Carob and Bhakti lounging on pillows and painting each other’s bellies with organic hot fudge, you might dismiss the idea of psychedelic therapy as the wishful thinking of New Age drug enthusiasts. link

In truth, it’s the other way around: Many of these substances began as therapeutic drugs before people started using them recreationally. For example, scientific studies conducted in the late ’50s and early ’60s showed LSD to have great promise as an aid to the treatment of disorders like alcoholism, drug addiction, sociopathology, criminal psychopathology, sexual deviance and anxiety or depression related to terminal illness. Complications set in when vast segments of the counterculture answered former psychedelic therapy researcher Timothy Leary’s call to “turn on” in the early and mid-’60s. The clinical and recreational use of the drug were quickly outlawed, prompting Sen. Robert Kennedy to comment at a 1966 congressional hearing, “Perhaps to some extent we have lost sight of the fact that [LSD] can be very, very helpful in our society if used properly.”

History repeated itself in the early ’80s, when more than a thousand U.S. psychotherapists were using MDMA (better known as ecstasy) in such endeavors as couples therapy and clinical depression treatment, claiming that it facilitated communication and allowed its users to examine their problems with significantly reduced fear. Largely through the evangelizing of former seminary student and self-proclaimed “ecstasy missionary” Michael Clegg, word soon spread that this remarkable compound had some desirable properties beyond the therapeutic. Once again, the law stepped in: In spite of a recommendation from Drug Enforcement Agency (DEA) Administrative Law Judge Francis Young that the drug remain legal for medical use by physicians, both the therapeutic and recreational use of the drug were banned in 1985.

The illegality of these substances hasn’t stopped psychedelic therapy research, but it has forced such studies to go underground. To this day, there are several full-time psychedelic therapists and many more therapists who occasionally work with psychedelics, all of them risking the gravest of consequences if they’re caught.

Here in Santa Cruz, however, there’s a psychedelic therapy organization that’s operating completely above ground. MAPS (Multidisciplinary Association for Psychedelic Studies), an IRS-approved nonprofit working to legalize the therapeutic use of psychedelic drugs and marijuana, is legally researching the use of not only MDMA for the treatment of Post-Traumatic Stress Disorder (PTSD), but also LSD and psilocybin (the active ingredient in psychedelic mushrooms) for the treatment of end-of-life anxiety, and the psychedelic alkaloid ibogaine as a possible cure for drug addiction. If these trials prove successful, these long-dreaded drugs could become highly valued, government-approved prescription medicines.

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MAPS founder Rick Doblin

 

 

MAPS president Rick Doblin founded the organization in 1986 after of working for a couple of years with the nonprofit group Earth Metabolic Design Laboratories to block the DEA from criminalizing the therapeutic use of MDMA. Doblin, a graduate of Harvard’s Kennedy School of Government, holds a doctorate in Public Policy relating to the regulation of the medical use of psychedelics and medical marijuana. “What I was able to do over those years [of study] is come to a pretty clear understanding of the political obstructions and forces that were working on both sides: to try to continue to suppress this research or to try to bring it to the surface,” he explains. Armed with this knowledge, he developed an organization that would “channel the people’s hopes that these drugs could become more accepted, not underground, and make a major contribution to society.”
Though the MAPS office and the majority of the organization’s staff members are located in Santa Cruz (for fear of attracting hangers-on seeking free drugs, they prefer that we not print their address), Doblin himself resides in Boston, while MAPS research and information specialist Ilsa Jerome, Ph.D. lives in Somerville, Mass. Doblin and Jerome work as a team with Santa Cruz staff members Valerie Mojeiko (director of operations), Randolph Hencken, M.A., B.S. (director of communications and marketing), Josh Sonstroem (accounting and IT) and Jalene Otto (membership and sales coordinator) by way of what Doblin refers to as “the miraculous technology of the 21st century.” 

In explanation of MAPS’ therapeutic approach, which is built on the work of the world’s leading LSD therapist, Stanislav Grof, M.D. (under whom Doblin studied a psychotherapeutic technique called holotropic breathwork from 1987 to 1990), Doblin comments, “When your body gets cut, you clean up the wound, and the body has this innate healing property: It tries to build the skin back together and recreate a whole, intact body. We feel like the psyche is the same: There are these innate healing capacities in the psyche, but sometimes they go awry, so if we can remove some of these impediments, which are often defenses against these powerful feelings, [healing can occur].”

Rick Doblin developed an organization that would “channel the people’s hopes that these drugs could become more accepted, not underground, and make a major contribution to society.”

The Agony and the Ecstasy

Doblin sees MDMA as the first psychedelic likely to be approved for therapeutic use due to the fact that with adequate support, people who have never taken drugs before can handle it, whereas the other psychedelics are more challenging. For this reason, the bulk of MAPS’ research is MDMA-based.
On a strictly biological level, MDMA reduces activity in the amygdala, a section of the brain that mediates the automatic fear response, while increasing activity in the ventromedial prefrontal cortex, which regulates emotional control. The result is that the MDMA taker is able to lower his or her defenses enough to examine his/her psyche with greatly reduced anxiety. “It’s astonishing how MDMA can alter patterns that have been under way for decades,” Doblin notes. “It may very well be that this difficult work can be done in remarkably short periods of time: Sometimes in a matter of minutes, when they’re emotionally ready, [MDMA takers] work their way through it.”

MAPS recently completed the first study in the world of the therapeutic use of MDMA. Twenty-one subjects between the ages of 26 and 54 took part in this FDA-approved examination of the drug’s efficacy in the treatment of Post-Traumatic Stress Disorder, which took place in Charleston, South Carolina from March 2004 to September 2008. Along with several survivors of childhood sexual abuse or rape, the participants included two veterans who had served in Iraq.

Drugs were actually a fairly small part of these double-blind, placebo-controlled trials: During the four months of treatment that each subject underwent, he or she only took MDMA on three different days, scheduled a month apart from each other. Multiple non-drug psychotherapy sessions preceded the first MDMA session, helping the patient to prepare for the experience in order to take maximum advantage of it, and the subject received daily therapy sessions for a week after each MDMA session to help him/her to integrate it. 
Overseeing these intense and often painful MDMA sessions were psychiatrist Michael Mithoefer, M.D., and his wife, psychiatric nurse Ann Mithoefer, B.S.N. In what Michael describes as a very comfortable, aesthetically pleasing office, the subject would take a capsule at about 10 a.m., not knowing whether it was MDMA or a placebo, and lie on a futon with the therapists on either side of him or her. A self-running machine measured the subject’s blood pressure every 15 minutes, thereby minimizing physical danger. All sessions were audiotaped and videotaped for patient review and to help MAPS perfect its method. Unless the patient requested otherwise, music was played to help “drive, amplify and calm the emotions,” as Doblin puts it. Approximately half of the eight-hour MDMA therapy session was spent in silence as the subject allowed various feelings and emotions to arise, and the other half was spent in therapeutic conversation.
Doblin claims that under the influence of MDMA, many patients remembered long-forgotten details of traumatic events. He adds that he and other staff members have talked to a great many people who have taken MDMA at raves or parties and spontaneously remembered sexual assaults or other traumatic experiences they’d previously blocked out of their minds. If the MDMA taker is surrounded by supportive people during such an incident, it can be a deeply healing experience, but all too often, she or he is surrounded by partiers who don’t want to be “brought down.” 

In a situation specifically designed to let the MDMA taker work through his or her trauma, however, the patient is not only permitted but encouraged to let it all out. “There will be different moments of crying, perhaps catharsis, fear, anxiety, of letting in these strong, strong emotions that have been plaguing people sometimes for 30, 40 years,” Doblin says. “Things at times will, from the outside, be looking like they’re getting worse: People can be shaking with terror, vomiting from nausea, crying, sobbing, but there’s a healing quality to all of that when people are processing emotions and feelings that have been stored for so long.”

This pilot study’s success rates are impressive indeed: Only 15 percent of the subjects who were given MDMA capsules still met the criteria for PTSD after treatment, as opposed to 85 percent of the people who were given placebos. Making these statistics all the more remarkable is the fact that the only people allowed to participate in the study were treatment-resistant: They’d failed to obtain relief from long-term psychotherapy or from the FDA-approved medications for PTSD. “These are preliminary results, and it’s a small study, but it’s certainly encouraging,” Dr. Mithoefer offers.

cover03Doblin says if the patient has responded well to the treatment, he or she no longer needs any drugs for PTSD, be they MDMA, Zoloft or Paxil. He adds that out of the 21 patients in the pilot study, three were on permanent disability due to their trauma before taking part in the study, and all three have returned to work since being treated. “If we just think about that, what that means is that in 2004, the Veterans Administration spent $4.3 billion on disability payments to 215,000 vets,” he observes. “That’s $20,000 per year on the average. Now, that’s before a lot of people started coming back from Iraq and Afghanistan with Post-Traumatic Stress Disorder.”

But does the patient come away from this therapy with a permanently heightened sense of well-being, or do the MDMA sessions merely provide fleeting tastes of freedom? Mithoefer is currently involved in a long-term follow-up study that will help answer that question. His general sense is that although maybe not everything the subjects get from the session is lasting, a significant amount of it stays with them. He stresses the importance of follow-up and integration in this process: “What we know about what [MDMA] does in the brain in terms of decreasing activity in the fear center and allowing people to have a state in which they’re able to process things is very powerful, and it shouldn’t be taken lightly, because it can stir things up. People can have more trouble afterwards, I think, if they don’t have good support and follow-up.”

“When your body gets cut, you clean up the wound, and the body has this innate healing property: It tries to build the skin back together and recreate a whole, intact body. We feel like the psyche is the same: There are these innate healing capacities in the psyche, but sometimes they go awry, so if we can remove some of these impediments, which are often defenses against these powerful feelings, [healing can occur].”
—Rick Doblin

Bad Medicine?

Leaving aside any psychological difficulty that might follow an MDMA experience, we come to the thorny issue of the drug’s well-publicized physical dangers, such as the risk of death by hyperthermia when a recreational ecstasy user dances all night in a hot, crowded environment without stopping to cool down or rehydrate. Conversely, if he or she overcompensates by drinking huge amounts of water, it’s possible for him/her to die from brain edema due to overhydration. Complicating the matter for recreational users is the fact that as a consequence of the drug’s illegality, the MDMA may be mixed with more dangerous substances, or the taker might simply be getting another, far deadlier drug altogether.

Assuming one is taking pure MDMA, however, risk of death is slim. An extremely eye-opening 2006 report by Peter Jennings (viewable here ) revealed that out of approximately 19,000 deaths reported to New York City’s Medical Examiner’s office over a period of about three years, only 22 of the deceased had ecstasy in their systems, and only two died from ecstasy alone. According to the DEA, during those three years, New Yorkers used about 110 million doses of ecstasy.

Doblin claims that death by MDMA is a one-in-a-million case, adding that a few years ago, MAPS did a statistical comparison of the risks of taking MDMA with those of cheerleading, with cheerleading proving to be the more dangerous activity. Both Mithoefer and Doblin hold that in a controlled environment such as the MDMA therapy study, where the subjects are being monitored and given a proper amount of fluids, the physical risks are extremely low. Helping to further minimize the danger, subjects are also screened for medical problems due to the fact that MDMA causes its taker’s blood pressure and pulse to go up considerably. (This isn’t dangerous for a healthy person, but it could prove problematic for someone with heart disease or cerebrovascular disease.)

Along with the threat of death, MDMA is often associated with brain damage. Many of these fears stem from a government-funded study led by neurologist George Ricaurte, M.D., Ph.D. of Baltimore’s Johns Hopkins Medical Institution. Published in the medical journal The Lancet in 1998, this report stated that ecstasy users risk losing up to 85 percent of the brain’s serotonin function. An unforgettable image associated with that study—the cranial PET scan of a woman who had supposedly put holes in her brain by taking a huge amount of MDMA—became a powerful weapon in an anti-ecstasy crusade led by the National Institute on Drug Abuse (hereNIDA). Space limitations prohibit a full account of the many ways in which that image and the study from which it was supposedly derived have been exposed as fraudulent, but interested parties are encouraged to look up the April 2002 New Scientist article “Ecstasy on the Brain” (http://mdma.net/misc/ecstasy-mdma.html), the December 2003 New York Times article “Research on Ecstasy is Clouded by Errors” (nytimes.com/2003/12/02/science/02ECST.html) and a German study of the effects of MDMA on serotonin levels, published in The Journal of Nuclear Medicine in 2003 (Link ).

Four years after the publication of the discredited Johns Hopkins study, at a time when fears of MDMA-induced serotonin depletion were waning, Ricaurte returned with a new MDMA study: This time he published a paper in the journal Science claiming that MDMA caused severe damage to the brain’s dopamine system and that a single, standard-sized recreational dose of ecstasy could cause Parkinson’s disease. After Science asked Ricaurte to respond to letters to the editor from MAPS staff that challenged these assertions, Ricaurte and his team were unable to replicate the results of their study, even after giving larger and larger doses of MDMA to the monkeys being studied and increasing the temperature of the room to increase neurotoxicity. In a scandal that severely tarnished the anti-MDMA movement’s credibility, it ultimately came to light that the monkeys had not been given MDMA in the original study, but methamphetamine. Along with being far more toxic than MDMA, methamphetamine is potent at much lower doses than MDMA (“Even 10 grams can be a lot,” Doblin notes) and has been shown to be harmful to dopamine. The Johns Hopkins researchers subsequently issued a full retraction of the article, admitting that all but one of the monkeys were accidentally injected with methamphetamine rather than MDMA. In his retraction letter to Science, Ricaurte blamed this discrepancy on a labeling error on the part of his chemical supplier, RTI International, which was overseen by the DEA.

Surprisingly, Doblin himself helped recruit volunteers and arrange the financing for Dr. Ricaurte’s studies. If this seems curious at first glance, it becomes less so in light of Doblin’s belief that with the government exaggerating the risks and denying the benefits of MDMA use, MAPS has to be careful not to do the opposite. “We try to be very careful about what we claim to be the benefits, and we try to design the best research studies possible looking into the risks of MDMA,” he states. “So there seems to be pretty much nothing to worry about. Certainly, in a therapeutic context, there is nothing to worry about in terms of neurotoxicity or
functional consequences.”

The functional consequences to which Doblin refers are mainly memory-related. Mithoefer states that there may be some evidence that taking high doses of MDMA frequently may cause memory problems for some people. “I think the jury is still out [on the issue of memory problems] in some ways, but we did neuropsychological testing before and after [the MDMA therapy sessions] and found no evidence of memory problems,” he offers. “When this dose is taken two or three times in a controlled setting, it doesn’t look like there’s a high probability of it causing any memory problems.”

A five-year, $1.8 million government-funded study that MAPS helped start is currently under way at Harvard Medical School. Scheduled to end in September, this study examines a population of people whose drug use has been limited almost exclusively to ecstasy. By Doblin’s account, the research so far has shown that in terms of memory, there are no substantial differences between people who have taken ecstasy and people who have never taken drugs.

The results of this research should not be taken as proof that there are no adverse consequences of recreational ecstasy use, but they do seem to indicate that the drug is reasonably safe for therapeutic use. “We’ve now been able to show through scientific research that these claims of risk are vastly exaggerated, that the denial of the benefits is completely wrong, and that really, we’re sitting on something that’s going to be making a major contribution to the psychiatry and psychotherapy of the future,” Doblin declares.

Health Trip

Along with various other studies of the treatment of PTSD with MDMA (including clinical trials in Switzerland, Israel, Canada and Jordan), MAPS is sponsoring a 12-subject trial in Switzerland examining the use of LSD in the treatment of clinical anxiety associated with life-threatening illness. Expected to be completed in the fall of 2010, this is the first study of LSD as a therapeutic aid in more than 35 years. Also currently under development is a study of psilocybin-assisted therapy in the treatment of end-of-life anxiety, to be held in an as-yet-undecided U.S. location, and an inquiry into the use of ibogaine in the treatment of opiate addiction, taking place in Playas de Tijuana, Mexico.

Because the effects of these other psychedelics are more unpredictable and more difficult to steer than those of MDMA, using such substances in a therapeutic context is a bit more challenging. “People require more support, more preparation, and it takes sometimes a lot more time spent negotiating with one’s defenses when you’re working with the classic psychedelics,” Doblin says. “But they still have this feeling that there’s something inherently healing about this emergence.”

According to the rules of FDA-approved research, MAPS is currently required to research these drugs one at a time, but there’s more and more talk among MAPS staff members of combining MDMA and LSD in therapy sessions, with the former helping to take some of the edge off the latter. Such a combination might prove especially useful in the treatment of PTSD, where caution needs to be taken to avoid re-traumatizing the subjects rather than helping them heal.

In spite of the delicate nature of giving psychedelic drugs to people suffering from trauma, Doblin claims that given a safe, supportive environment and adequate preparation, the study subjects may do a lot of grappling, but they can generally handle the experience. “It just takes a lot of work and courage to get to the point where one opens to it,” he says.

“The federal government has a monopoly on the supply of marijuana, and has for the last 40 years hindered research into making marijuana into a prescription medicine.”
—Rick Doblin


Pipe Dreams?

cover_marijuanaleafPerhaps the most challenging of MAPS’ efforts is its ongoing push for legalization and FDA approval of marijuana as a prescription medicine. “The federal government has a monopoly on the supply of marijuana and has for the last 40 years hindered research into making marijuana into a prescription medicine,” Doblin asserts. MAPS has been wrestling with this issue since 1990, when its staff conducted a survey comparing smoked marijuana with the oral THC pill as used in cancer therapy. The organization also worked throughout the ’90s with UCSF’s Dr. Donald Abrams to start a study of the use of medical marijuana in HIV-positive patients as well as with Montana State University’s Dr. Ethan Russo to start a study of the use of cannabis for the treatment of migraines, only to find its efforts blocked by NIDA. MAPS, which has also been working with California NORML (National Organization for the Reform of Marijuana Laws) since 1993 to sponsor research on the use of vaporizers and water pipes as a means of reducing the physically damaging effects of smoking cannabis, has been unsuccessfully attempting to purchase marijuana from NIDA for more research in this area since June 2003.

MAPS is now attempting to get an FDA license for a medical marijuana farm at UMass-Amherst in order to produce marijuana that would be acceptable for use in FDA studies. Six days before Obama took office, the DEA rejected a recommendation by its own Administrative Law Judge, Mary Ellen Bittner, who, after extensive hearings, recommended approval of the license. MAPS staff members are presently waiting to find out if they’ll be given a chance to appeal this decision. According to Doblin, with the DEA still under old leadership appointed by former President George Bush, MAPS hopes to continue its legal struggles long enough for new leadership to come into the DEA. If not, Plan B is to sue the DEA through the First Circuit Court of Appeals.


At 10 a.m. Saturday, Aug. 8, locals will have an opportunity to discuss these complex matters with Rick Doblin and other MAPS staff at a brunch where Doblin will talk and take questions about the organization’s current state and future plans. This $25 event, which is open to MAPS members and to the general public, takes place at Peachwood’s Steakhouse, located at the Inn at Pasatiempo, 555 Highway 17, Santa Cruz. Reservations are encouraged by Tuesday, Aug. 4, and required by 4 p.m. Friday, Aug. 7. Tickets are available through MAPS’ website (maps.org) or by calling MAPS’ office at 429-6362.

 

Comments (1)Add Comment
Treatment of Migraines
written by Treatment of Migraines, October 16, 2010
This is crazy! Drugs only mask the problem. Find out what is causing the problem and fix it, don;t hide it with medications. The treatment of migraines deals with the same problems. Everyone wants to be drugged up rather than identifying what the problem is and fixing it. http://www.themigrainedoctor.com

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