Dr. Rick Doblin - MAPS

Transcendental Medication

A 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.

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.
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.Doblin 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 (NIDA). 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?
Perhaps 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.

Psychedelic Psychiatry

Can psychedelics have a role in psychiatry once again?

BEN SESSA, MBBS, BSc, MRCPsych

The Park Hospital, Old Road, Headington, Oxford OX3 7LQ, UK. E-mail: drbensessa@hotmail.com

DECLARATION OF INTEREST

None.

Psychedelic or hallucinogenic drugs such as lysergic acid diethylamide (LSD), 3,4,5-trimethoxy-ß-phenethylamine (mescaline), psilocybin, 3,4-methylenedioxymethamphetamine (MDMA), N,N-dimethyltryptamine (DMT) and their relations occur in abundance throughout the natural world, and have been used by humankind for thousands of years.

In some cultures they are important tools for spiritual experiences, whereas in others they are labelled as dangerous drugs of misuse. What is less well known about these substances is the role they played in psychiatry for a brief historical interval. This article offers a short overview of this period and questions whether interest in these compounds might be emerging again.

CURRENT TRAINING AND KNOWLEDGE ABOUT PSYCHEDELICS

Despite their history, psychedelics have dropped out of psychiatric dialogue for today's trainee psychiatrists (Strassman, 2001). In my own training, references to compounds like LSD, psilocybin and MDMA were usually followed by statements such as ‘have no medical use’. But I was taught about the acute emergencies and social problems associated with their misuse.

Yet in the years between the first synthesis of LSD in the 1930s and the disappearance of psychedelic research by the late 1960s, there was a furious growth of scientific interest in these substances. Many pioneers gave their careers to this field, hoping that psychedelic drugs could be to psychiatry what the microscope is to biology or the telescope is to astronomy: an essential tool to explore the parts of the internal world that are usually inaccessible (Grof, 2001).

HISTORY OF PSYCHEDELIC RESEARCH

The Swiss chemist, Albert Hoffman first synthesized LSD-25 while studying derivatives of the fungus ergot for use as potential medicines. When he accidentally absorbed some LSD during a laboratory session there followed an intense experience of perceptual and emotional effects (Hoffman, 1980).

By the late 1940s psychiatrists were beginning to experiment with LSD as a tool, and in 1951 it was the subject of a presentation at the annual conference of the American Psychological Association. Initial work explored the possibility that psychedelics might be used as ‘psychotomimetics’, to mimic the mental states of patients with schizophrenia (Osmond, 1957), and many health professionals were encouraged to partake in self-discovery or shared psychedelic experiences with their patients. Other research looked into using psychedelic drugs as adjuncts to psychotherapy. The therapy took the form of two broad types: first, psycholytic (‘mind loosening’) psychotherapy involved taking low doses of LSD as part of ongoing psychoanalytical therapy. The drug had a loosening effect and facilitated the exploration of repressed material. The second type, psychedelic (‘mind manifesting’) psychotherapy involved preparation sessions without LSD, then one single large-dose session that encouraged an intense reaction, followed by further non-drug sessions to explore the meaning of the material that emerged (Grinspoon & Bakalar, 1997).

By 1965 over 2000 papers had been published describing positive results for over 40 000 patients who took psychedelic drugs with few side-effects and a high level of safety (Masters & Houston, 1970). The techniques were applied to the treatment of anxiety disorders, obsessive-compulsive disorders, depression, bereavement reactions and sexual dysfunction, among others (Newland, 1962; Grof, 2001). In the treatment of addiction, repeated controlled experiments demonstrated a consistent recovery and 6-month abstinence from drinking in 50-90% of participants after brief psychedelic therapy (Abramson, 1967; Hoffer, 1970). Another area where therapy was used successfully was in relieving pain and anxiety in terminal cancer (Kast, 1964).

PROBLEMS WITH PREVIOUS RESEARCH

Despite the volume of publications from this period, most of the published material refers to anecdotal case reports that are of little value by contemporary research standards because they lack sufficient follow-up and control participants (Grob, 1994). Even though results appeared promising, by the 1970s, under pressure from the US justice department, virtually all research had ended. LSD had leaked from the scientific community to a wider audience. By 1966 LSD misuse had become a problem and its possession was made illegal. This prompted the scientific community to distance themselves from interest in such substances. Governments clamped down on research licences, and increasing reports of adverse reactions to psychedelics taken recreationally as opposed to those used in controlled, scientific circumstances (which remained safe) appeared in the literature (Strassman, 2001). As a result, research use ceased while illicit use remained, fuelled by a growing criminal distribution and financial system.

Until very recently, research on psychedelic drugs has been severely restricted, which explains the current lack of knowledge among psychiatrists.

CURRENT RESEARCH

Since the 1970s, MDMA psychotherapy has seen an emerging underground use by analysts. MDMA, strictly speaking an ‘empathogen’ rather than a psychedelic drug, is less intense and shorter-acting than LSD. It appears to offer a similar therapeutic potential for lowering a patient's defences and aiding the psychotherapeutic process (Holland, 2001).

A lifting of the government ban on psychedelic research in Switzerland between 1988 and 1993 allowed a brief recommencement of psycholytic psychotherapy using LSD and MDMA for patients with personality disorders, affective disorders and adjustment disorders. There are currently projects under development in Spain, Israel and the USA looking at MDMA-assisted psychotherapy in the treatment of post-traumatic stress disorder and as a treatment for anxiety and depression associated with cancer. Between 1990 and 1995 extensive studies of DMT, a strong but short-acting agent, were conducted with human participants in the USA (Strassman, 2001). Other research includes a double-blind placebo controlled study in Russia using ketamine in the treatment of heroin addiction, which has demonstrated improved rates of abstinence, maintained at 2-year follow-up (Krupitsky et al, 2002). Also in progress are studies looking at psilocybin in the treatment of obsessive-compulsive disorder and for reducing anxiety and pain in cancer patients. All of this research is well summarised on the Multidisciplinary Association for Psychedelic Studies (MAPS) website (http://www.maps.org/).

ONGOING PROBLEMS WITH CURRENT RESEARCH

Although drug misuse remains a growing phenomenon in our global society the public and governments are suspicious of psychedelic research. The image of psychedelics, severely damaged by the 1960s drug culture, is further spoiled by drug use in today's ‘rave’ scene. Finding unbiased information about psychedelic research is often difficult.

However, many of the early pioneers of psychedelic research continue to promote it for the field of mental health. Dr Humphrey Osmond, the British psychiatrist who, in communication with the author Aldous Huxley, coined the term ‘psychedelic’ in the 1950s, strongly supported psychedelic research until his death last year aged 86 years, when he received a fitting tribute in the BMJ (Hopkins Tanne, 2004). Albert Hoffman, who celebrated his 99th birthday this year, maintains contact with organisations promoting scientific research into medical uses for psychedelic drugs, such as MAPS and the Heffter Research Institute (http://www.heffter.org/).

Researchers believe these drugs are important tools for further academic study. Their recognised psychological effects fit well into an approach looking for the neurobiological links between mental and physical states. Also from a clinical point of view, the practice of traditional psychedelic psychotherapy - using the drugs as an adjunct to brief, time-limited psychotherapy - has much in common with the current practice of cognitive-behavioural therapy.

CONCLUSION

Perhaps it is surprising that there remains such considerable ignorance about the potential of these substances from within psychiatry itself. As with Galileo's telescope and Darwin's suggestion of our ascendancy from apes, radical scientific challenges tend to take the form of an attack on the anthropocentric model of the world. In the light of this, research that explores alternative states of consciousness and then offers a viable neurobiological substrate for the very human experience of religious encounter is bound to meet with objection from a generation of psychiatrists who have been conditioned to consider such work as ‘mysticism’. Perhaps a more dispassionate criticism based upon scientific reasoning and not influenced by social or political pressures is called for if we are truly to investigate whether these substances can have a useful role in psychiatry today.

REFERENCES

1. Abramson, H. A. (1967) The Use of LSD in Psychotherapy and Alcoholism. New York: Bobbs-Merrill.
2. Grinspoon, L. & Bakalar, J. B. (1997) Psychedelic Drugs Reconsidered. New York: Lindesmith Center.
3. Grob, C. (1994) Psychiatric research with hallucinogens: what have we learned? In Yearbook for Ethnomedicine (eds C. Ratsch & J. Baker). Berlin: Verlag für Wissenschaft und Bildung.
4. Grof, S. (2001) LSD Psychotherapy. Sarasota, FL: Multidisciplinary Association for Psychedelic Studies.
5. Hoffer, A. (1970) Treatment of alcoholism with psychedelic therapy. In Psychedelics, The Uses and Implications of Hallucinogenic Drugs (eds B. Aaronson & H. Osmond). London: Hogarth Press.
6. Hoffman, A. (1980) LSD: My Problem Child. London: McGraw-Hill.
7. Holland, J. (2001) Ecstasy: The Complete Guide. Rochester, VT: Park Street Press.
8. Hopkins Tanne, J. (2004) Obituary for Humphrey Osmond. BMJ, 328, 713 .[Free Full Text]
9. Kast, E. (1964) Pain and LSD-25: LSD-25: A theory of attenuation and anticipation. In LSD: The Consciousness Expanding Drug (ed. D. Solomon), pp. 241 -256. New York: GP Putman.
10. Krupitsky, E., Burakov, A. & Romanova, T. (2002) Ketamine psychotherapy for heroin addiction. Journal of Substance Abuse Treatment, 23, 273 -283.[Medline]
11. Masters, R. E. L. & Houston, J. (1970) Therapeutic applications of LSD and related drugs. In The Uses and Implications of Hallucinogenic Drugs (eds B. Aaronson & H. Osmond). London: Hogarth Press.
12. Newland, C. (1962) My Self and I. New York: The New American Library.
13. Osmond, H. (1957) A review of the clinical effects of psychotomimetic agents. Annals of the New York Academy of Sciences, 66, 418 -434.[Medline]
14. Strassman, R. (2001) DMT: The Spirit Molecule. Rochester, VT: Park Street Press.

Received for publication January 27, 2004. Revision received November 12, 2004. Accepted for publication November 21, 2004.

Research on psychedelics moves into the mainstream

Research on psychedelics moves into the mainstream

Kelly Morris

The Lancet

Volume 371, Issue 9623, 3 May 2008-9 May 2008, Pages 1491-1492

The backlash against the recreational use of psychedelic drugs in the 1960s had a negative effect on research into their potential therapeutic benefit. But now attitudes are changing and work in this area is being revitalised, with several early-stage trials underway. Kelly Morris reports.

Some 50 years ago, substances called psychedelics were hailed as the new tools of psychiatry. After their use in diverse clinical contexts, not always with rigorous methods, and following widespread non-medical use, “research was quashed for misguided but understandable reasons”, explains Rick Doblin, president of the US Multidisciplinary Association for Psychedelic Studies (MAPS). Now, that scenario is rapidly changing, with several phase II trials underway worldwide, and many more studies ongoing or planned. “It's amazing how much is going on”, Doblin told The Lancet after the World Psychedelic Forum that took place in Basel, Switzerland at the end of March.

Part of this resurgence, say experts, is down to a more measured attitude of researchers towards the risks and the benefits of drugs like lysergide (LSD), psilocybin, and methylenedioxymethamfetamine (MDMA). “What we see now is the [US] FDA (Food and Drug Administration) making decisions based on data rather than politics, and major universities involved in research”, notes Tom Roberts, a professor of educational psychology from Northern Illinois University, IL, USA, and co-editor of the book Psychedelic Medicine. Clinical studies are the most appropriate context to start re-exploring the use of psychedelics, says Roberts, because of rigorous review processes and the step-by-step development of studies. The “Timothy Leary era” of informal or illegal explorations “caused a lot of problems”, he notes. Ben Sessa, a consultant psychiatrist based in the UK, agrees. “At the end of the 1960s these drugs were labelled as dangerous drugs of abuse in the wake of the explosion of recreational use by the general public. The resulting war on drugs has been only minimally effective at tackling recreational use but has been extremely damaging for any genuine medical research”, he says.

What the experience of the 1960s has shown is pointers to many possible therapeutic and non-medical uses. “The evidence so far suggests that the anxiety (neurotic) disorders tend to do well with psychedelics—that includes anxiety, post-traumatic stress disorder, and obsessive-compulsive disorder. This is because these drugs are particularly good at allowing the user to access otherwise repressed and painful memories and do some meaningful psychotherapeutic work under the influence of the drug”, says Sessa. Previous clinical experience, plus more recent informal use, has indicated other potential therapeutic uses for cluster headaches and addictions, among other conditions.

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The therapeutic benefit of MDMA is being tested in pilot studies for post-traumatic stress disorder

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Some of the first clinical trials have focused on MDMA, which is not a classic hallucinogen. Doblin was keen to develop protocols for formal phase II studies given the drug's reported capacity “to enhance people's ability to feel, accept, and integrate difficult emotions” within a psychotherapeutic context. Of MAPS' three pilot studies for post-traumatic stress disorder worldwide, the US study ends first, in July. Three further phase II studies are in planning. “What we need to do is to replicate the US findings”, says Doblin, who then hopes to see the development of phase III trials in Europe and the USA, which, if positive, could pave the way for MDMA to be available as a prescription medicine.

“We have shown that LSD [historically] and MDMA given in a psychotherapeutic context can be safe”, notes Doblin, but he emphasises that the therapeutic outcome seems highly dependent on the therapeutic context. Thus, as Roberts explains, “in psychotherapeutic sessions, psychedelics are best thought of as adjuncts to psychotherapy, not as whole treatments themselves”. Doblin concurs: “We are talking about reversing a lifetime of patterns, in some cases, so the magic bullet or single-dose miracle cure theory is out the window. Multiple doses are needed in the context of long-term psychotherapy.”

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Psychedelics might be of benefit in the treatment of cluster headaches

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Now, the first clinical trial of psilocybin in terminal cancer patients led by Charles Grob at the University of California is nearing completion, and others are recruiting or about to start further investigating psilocybin, MDMA, or LSD in similar situations. For example, a study led by Stephen Ross and Anthony Bossis from the New York University School of Medicine, NY, USA, is about to commence using psilocybin with psychological support, with endpoints that include reductions in anxiety, depression, pain, and increased acceptance of death. “I am interested in novel ways to relieve suffering for end-of-life cancer patients”, says Bossis. “We are looking to determine whether a mystical state can alleviate the psychosocial and existential anxiety associated with the end of life.” Roland Griffiths from Johns Hopkins University School of Medicine, Baltimore, MD, USA, is also researching the effect of psilocybin on anxiety surrounding cancer diagnosis; this trial is unique in that patients with and without disease progression will be eligible.

Amanda Neidpath, director of the UK Beckley Foundation, has been working for years to initiate new research on LSD, by collaborating with various groups worldwide. In addition to therapeutic research, she believes “we need to understand the mechanisms by which we get these changes of perception that may be beneficial…how these substances work, how they are helpful, and for whom”. Also, since psychedelics would not be efficacious in everyone, an understanding of mechanisms may point to non-psychedelic means to achieve the same therapeutic effects. Research on mechanisms might also help explore other potential uses for psychedelics. One such study about to commence will investigate the effects of LSD on brain connectivity and sensory processing, which might clarify previous suggestions about how psychedelics might enhance cognition and creativity.

“As our view of the human mind and nervous system expands, it is being recognised that different mind-body states, different from our waking state, are also useful”, says Roberts. One such state, which has been anecdotally linked with enhanced wellbeing and anti-addictive properties, is the group use of ayahuasca. This ancient compound is not pure, but a mixture of plants used mainly by indigenous and spiritual groups. Traditional mixtures vary, but all contain a source of the psychedelic dimethyltryptamine plus a compound to prevent its gastrointestinal breakdown.

Jordi Riba and a team led by Manel Barbanoj from the Hospital de Sant Pau in Barcelona, Spain have been studying ayahuasca in healthy volunteers for about 10 years. Using a freeze-dried preparation, administered at standard doses of the active alkaloids, the team have done tolerability and pharmacokinetic studies in addition to collecting data on neuroendocrine, immune, and subjective parameters. “During the acute phase [3–4 h], volunteers reported having gone through a deeply introspective and emotional experience with thoughts usually revolving around personal concerns”, notes Riba. “Most participants found this interesting and useful, and it is in this remarkable characteristic of ayahuasca where the potential for modifying self-destructive behaviours, such as drug abuse, could reside”, he speculates. EEG and SPECT studies have confirmed changes in brain electrical activity and blood flow consistent with these subjective effects, and now the team plans to assess the effect on long-term healthy users.

In learning lessons from the 1950s and 1960s, researchers in general remain cautious about the potential for psychedelics and how they are investigated. Roberts notes that except for a study on cluster headaches (which reviewed informal use), all studies presented at the recent Basel forum specify that psychedelics are taken in the presence of a trained professional, and programmes for educating and training professionals are starting to be developed. MAPS is planning to seek FDA approval for a training programme for psychotherapists or nurses to become psychedelic psychotherapists. Ross, with Jeffrey Guss, has developed a course on psychedelic medicine, taught earlier this year to a group including medical students, psychiatry residents, and post-doctoral addiction fellows at Bellevue Hospital department of psychiatry in New York, USA. The course focuses on use of psychedelics for addiction.

The development of education in parallel with research is essential to ensure an academic focus towards psychedelic medicine, Ross and others believe. “Often people hold very passionate and pseudo-scientific opinions about these drugs on both sides of the debate. As clinicians, we need to remain dispassionate and hold true to the principles of evidence-based medicine…we owe it to those patients who may benefit from this approach”, says Sessa.

Psychedelic healing

Torsten Passie is one of the very few scientists in the world who dare to work on the positive effects of hallucinogenic drugs. His research centres on the life-enhancing and therapeutic effects of the most powerful mind-altering drugs known to science, including hallucinogens, psychedelics (literally "mind-revealing" drugs) and entactogens (substances that induce a deep change in feelings). These are drugs that can turn your mind inside out, throwing everything into question. An LSD trip can be a terrifying whirlwind of horrific hallucinations, a delightful journey of discovery or even a mystical experience.

But while the dangers of hallucinogens are well known, the stigma of their illegality makes it nearly impossible to discuss, let alone research, their positive potential. Could they help the dying, the depressed or the mentally ill? If so, argues Passie, perhaps we should treat them more like dangerous sports - acceptable if treated with caution - rather than ban them and push them underground. Susan Blackmore met him earlier this year at an occasion that could hardly have been more appropriate: a conference in Basel celebrating the 100th birthday of Albert Hofmann, discoverer of LSD.

Why are you willing to put your reputation on the line to work with hallucinogenic drugs?

I have long worked on altered states of consciousness, looking at their philosophical implications, but I'm also interested in temporarily inducing severely altered states. I want to explore these states and make scientific experiments on them, including those induced by using hallucinogens.

Isn't it almost impossible to get grants and licences to use these drugs?

Licences aren't really the problem. I have permission to work with cannabis, ketamine and psilocybin, and it was no big problem to get it, but then I've been in the field more than 20 years and I know all the literature. My head of department has done a lot of work with cannabis before. He did have problems with ethics committees, but now we've got permission for everything we want. If you know what you're doing, they'll give you permission. Grants, however, are nearly impossible to get.

Why are you doing this work?

My personal interest is because I worked for many years with Hanscarl Leuner, who did pioneering work with LSD in the 1960s and continued research on hallucinogen-assisted psychotherapy until the 1990s. My intention is to rediscover the therapeutic potential and applications of these substances.

What kind of patients can these drugs help?

Nearly all kinds of patients with neurotic and psychosomatic diseases can be helped, as shown by the 300 to 400 studies from the 1950s and 1960s. Especially appropriate may be patients with anxiety neuroses, depressive neuroses and post-traumatic stress disorder.

How can these drugs help them?

It seems that MDMA (ecstasy) and the entactogens can detraumatise people from experiences that have left them in states of heavy tension and friction. To achieve this you first have to prepare a safe and stable therapeutic relationship with the patient so as to have a safe inner setting, and you need a safe external setting too. We found that these ways of experiencing oneself, others and the world are very productive and can promote what is essentially a self-healing process.

People can confront their memories in a state not limited by neurotic fear and inner defences - they can really open up. It seems they can mainly self-organise the processing of their experiences to promote their own healing. They can see that it's safe, and that it's nice to be open again. After that they may not go back into a closed state and you can work psychotherapeutically with them in a much more effective way.

You mean you provide the setting, the drug and the support and they do it themselves?

That's right. It activates their self-healing power. This may be problematic for therapists because they are kind of useless then. This is something that people don't realise: that normally therapists are trying to influence somebody in some way. Here you don't have to. You only have to furnish a room nicely, do some background work, and then the process happens without danger and with great potential for a lot of people.

The earlier researchers found that you should do therapy in mixed groups, treating people with different kinds of neurosis together. In a scientific design you would use people who all have the same kind of neurosis, but that's counterproductive for therapy. We would like to give them MDMA first because it's easier to handle and then give them LSD a few times.

Are you also interested in how healthy people use drugs for recreation?

I am, because from these people we may learn how you can misuse the drugs or use them in an appropriate manner. When I worked with Hanscarl Leuner he was allowed to do therapy only on severe neurotics who were resistant to treatment, because of all the panic and phobia surrounding LSD in those days. We found that these people can profit from hallucinogens, no question, but the more healthy the people are, the more they can profit, because healthy people have a greater capacity for self-healing.

But why, if these drugs have such great healing potential, aren't they available to use?

There are two reasons. Firstly, any patents on them ran out long ago. No pharmaceutical company will finance a study if it gets nothing out of it. This is a major reason why we can't get money for our studies and especially for clinical studies, which are quite expensive.

The second reason is that pharmaceutical companies are not interested in things that patients have to take only once. They're more interested in something like a hair-growing ingredient that people have to take every day and if they don't take it their hair will fall out again. That's what they're looking for. With a depressed patient, the physician may say, "Take this SSRI [selective serotonin reuptake inhibitor] anti-depressant medication and you will be better." Sure, they will be a little better, but they have to take a pill twice a day.

You mean you could heal them once and for all?

As potential therapists, we would give them MDMA perhaps three times and LSD twice. Who could earn money out of it? From five doses? And after psychedelic therapy, the patient may be much better or completely healed, rather than showing slightly improved symptoms and having to take the medication for years. So in a way the pharmaceutical company is our enemy.

Are there many others working in this field?

I'm really on my own. This is the real problem, that there are so few people who are seriously scientifically interested. It's astonishing because a lot of people try to get information out of you, especially journalists, but they usually only want to have an impression of a special facet of the topic. They don't want to take on the therapeutic applications, or the religious and spiritual potential of these drugs. So normally I don't give interviews and I don't have that many students.

Profile

Torsten Passie is assistant professor for consciousness studies at Hanover Medical School, Germany. He has done extensive research on the use of hallucinogenic drugs, altered states of consciousness and shamanic practices in psychotherapy and healing.

Susan Blackmore will be talking about the dangers and benefits of LSD at Unhooked Thinking, an international conference on the nature of addiction at the Assembly Rooms in Bath, UK, 19-21 April (www.unhookedthinking.com).

http://www.newscientist.com/article/mg19025471.500-interview-psychedelic-healing.html?page=1