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Psychedelic drug 'hope for OCD' December 11, 2006 - BBC
"Doc, I am ready to play ball."
It had been years since Jeff (not his real name) had touched a basketball.
Living with obsessive-compulsive disorder (OCD), Jeff feared contamination from dirt and germs which prevented any part of his body from touching the ground, save for the soles of his shoes.
But whilst taking part in a small clinical study to investigate the effects of psilocybin, the hallucinogenic compound found in 'magic' mushrooms, on people with OCD, Jeff's bare feet lay on the floor and he expressed a willingness to engage in an activity, playing ball, that just hours before would have been considered abhorrent.
Although Jeff's symptoms gradually returned other patients also experienced transient relief from their OCD symptoms and one entered an extended period of remission lasting more than six months.
Lead researcher Dr Francis Moreno, Associate Professor of Psychiatry at the University of Arizona, Tucson, said: "I really think that participating in the study influenced the patient's remission."
But critics say the study's flawed methodology means that conclusions cannot be made about psilocybin's efficacy against OCD, and some question whether it should have taken place at all.
Professor Jeremy Schwartz, of the University of California, Los Angeles, said: "The cultural impact doesn't seem to be adequately thought through.
"This study is going to receive a lot of attention and it will create a desire on behalf of a patient population that is suffering and hoping for a 'magic bullet'."
However, the study's authors say that the primary purpose of the study was to demonstrate safety.
Dr Moreno said: "This was a proof of concept, phase I study, which means it tested safety and not clinical benefit.
"If we view this study as the one who should provide evidence of clinical efficacy, this is the wrong design.
"If the question is: 'did we find enough information to support exploring this further?', then we got some interesting findings which support the need for a proper controlled study."
There are an estimated six million OCD sufferers in the US, making OCD the fourth most commonly diagnosed psychiatric disorder after phobias, depression and alcoholism.
OCD is an anxiety disorder characterised by the repetitive or ritualistic performance of behaviours such as excessive washing, checking, and counting.
Sufferers can be plagued by intrusive thoughts, ranging from unwanted sexual fantasies to committing violent acts.
OCD is treatable although the cause is not fully understood.
SSRIs (Selective serotonin reuptake inhibitors) such as fluoxetine (Prozac) or the tricyclic antidepressant clomipramine are commonly prescribed and can be highly effective - 60% of patients on medication improve.
The response rate can be even higher when combined with cognitive behavioural therapy, a type of psychotherapy that focuses on solving the patient's present problems.
But half of patients relapse when drugs are withdrawn and a quarter does not respond to conventional therapies at all.
Even when medication is effective, a 30-50% reduction in symptoms is the best that can be achieved, a far cry from the freedom to enjoy life that millions crave.
And if the therapy and drugs don't work, invasive brain surgery is the only remaining option.
The need for more treatment options and anecdotal reports of OCD patients undergoing periods of remission after using hallucinogens led Moreno and colleagues to give low (8mg), medium (16mg), and high (24mg) doses of psilocybin to nine people who had failed to respond to at least one conventional treatment regimen.
The participants' OCD symptoms were then measured using a modified form of the YBOCS (Yale-Brown Obsessive Compulsive Scale) questionnaire - a ten-point survey that asks the patient to rate the time spent performing compulsions or battling obsessive thoughts.
A statistically significant reduction in OCD symptoms after psilocybin ingestion was recorded for up to 24 hours, but the lack of a control group - the same patients on a different drug or no drug at all - means that it could have been care and attention from the researcher that lessened their patients' anxieties.
A measurable reaction from a very low dose of just 2mg, less than is considered pharmacologically active, also suggests a placebo effect at work - or perhaps a tantalising glimpse that psilocybin could be effective at sub-hallucinogenic doses - without a control group it's impossible to tell.
But why take a psilocybin trip for OCD? The biochemical rationale is that psilocybin and the mood regulating chemical serotonin are both tryptamines and have a similar molecular structure.
Psilocybin actively binds to certain serotonin receptors in the brain's nerve cells - sites that serotonin would normally lock into - and this agonistic mechanism results in the mind-altering effects, which, depending on the dose, can send users on a psychedelic voyage to the edge of human consciousness.
Apart from one transient occurrence of hypertension, the subjects rated the hallucinogenic experience as "stressful" at some times but "psychologically and spiritually uplifting" overall and described encounters with past lives, far away planets, and communing with deities.
But this favourable reaction could be biased because only participants who had tolerated at least one exposure to psychedelics before were selected.
Dr Moreno said: "The Human Subject's Committee at our institution required prior experience with hallucinogens as a way to increase safety."
Even so other scientists are not convinced that safety issues have been adequately addressed.
Dr Paul Blenkiron is a consultant in adult psychiatry at Bootham Park Hospital, York.
He said: "I'm concerned that the study only measured effects up to 24 hours and OCD is a chronic condition, not measurable in hours and days, but months and years.
"About 12% of people can suffer flashbacks after less than 10 exposures [to psychedelics] many years later, beyond the 6 months of this study, so long term effects should be carefully assessed."
However, he said that for treatment-resistant patients, alternatives to neurosurgery would be worth considering.
"If this substance was effective and had fewer side effects in severe treatment-resistant cases it would be an option."
Experts also question whether the results are really valid, in particular relating to the reported remission.
"You would expect a spontaneous remission rate of 10% within in a year," said Professor Paul Salkovskis, Maudsley Hospital Centre for Anxiety Disorders, who asks whether it is safe to give people with OCD psychoactive substances at all.
"I'm very concerned that people with obsessional problems who experience bursts of nasty images, like sexually abusing their own child or stabbing someone, are being given a drug known to produce intrusive mental phenomena."
Patient groups prefer an evidence-based approach.
Ashley Fuller, chief executive of the leading charity OCD-UK, said: "OCD-UK certainly welcome all research into the treatment of obsessive-compulsive disorder provided it is carried out to ethical standards and in a safe environment for the patients."
Published in the Journal of Clinical Psychiatry, the study is the first research investigating the therapeutic benefits of psilocybin to appear in a peer-reviewed journal for more than 30 years.
A clutch of similar studies using MDMA (ecstasy), LSD or psilocybin for other conditions such as post-traumatic stress disorder are currently underway in the US and are planned for Israel and Switzerland.
Many of the new wave psychedelic research projects are part-funded or initiated by MAPS, the Multidisciplinary Association for Psychedelic Studies, a loose alliance of scientists and supporters who campaign for changes in drug laws.
Rich Doblin, MAPS founder, said: "MAPS spent US$12,250 for the world's most expensive gram of psilocybin.
"Not exactly a bargain, but worth it to enable the research to take place."
In a small-scale preliminary study, a UA psychiatrist has found that psilocybin, the active agent in psychedelic mushrooms, is effective in relieving the symptoms of people who suffer from severe obsessive compulsive disorder.
Dr. Francisco A. Moreno and his colleagues conducted the first FDA-approved clinical study of psilocybin since it was outlawed in 1970. The results are published in the latest edition of the Journal of Clinical Psychiatry.
Moreno cautions that the study was simply to test the safety of administering psilocybin to OCD patients. The effectiveness of the drug is still in question until a larger controlled study can be conducted.
Still, in each of the nine patients in the study, psilocybin completely removed OCD symptoms for a period of generally four to 24 hours, with some patients remaining symptom-free for days. "What we saw acutely was a drastic decrease in symptoms," he said. "The obsessions would really dissolve or reduce drastically for a period of time." People would report that it had been years since they had felt so good, he said.
Provisions and policies for scientific research of controlled substances like psilocybin were included in the 1970 Comprehensive Drug Abuse Prevention and Control Act, which outlawed psilocybin. New research into psilocybin does not reflect any change in government policy, said Rogene Waite, a spokeswoman for the Drug Enforcement Administration. The same review process has governed such research the entire time although researchers may have been hesitant to consider using psilocybin in the past, she said.
Currently, there is no treatment in the medical literature that eases OCD symptoms remotely as fast, Moreno said. Other drugs take several weeks to show an effect, but the psilocybin was almost immediate.
Still, it's not a drug patients could take daily and in any case, doctors don't know what would happen with repeated use: Would the effects be additive and longer-lasting over time? Or would the effects dissipate as the patient developed a tolerance? Moreno, who is in "grant-seeking mode," said the next step is to conduct an expanded study. The findings would be far more convincing on the effectiveness of psilocybin in OCD patients, he said. "We're very cautious about making too much of the early results," Moreno said. "I don't want to characterize it as psychedelics are the way to go. Although it seemed to be safe, this was done in the context of supervision by trained professionals in a medical setting. This is not ready to be used by the public just because nine people tolerated it."
A spokeswoman for the Food and Drug Administration declined to comment on the research, citing "confidentiality."
Moreno, whose specialty is in treatment resistance, started thinking about the psilocybin study in the mid-1990s after a patient said the only time he was ever free of OCD symptoms was a decade earlier in college when he experimented with psychedelic mushrooms. Psilocybin and other drugs in that family work by activating certain serotonin receptors, in some ways similar to the mechanisms of anti-depressants used to treat OCD.
Moreno examined the medical literature on psilocybin and LSD and found some other cases in which OCD patients reported improvement under similar conditions. He started the study in 2001, gradually recruiting patients through 2004.
Under strict rules to guard against complications, Moreno gathered nine OCD patients who had treatment with the typical medications and had prior positive experience with psychedelic drugs. The patients were tested between one and four times, with 29 sessions in all.
They were administered one of four dose levels of psilocybin in the morning and were monitored in a modified office for eight hours. The patients were given eye shades and listened to music, with instructions to turn their attention inward.
They were each interviewed at the end of the day about their experiences and kept in the hospital overnight to make sure they had no drug complications.
The patients had a range of obsessions and compulsions, including fear of being contaminated, elaborate cleaning rituals, tapping or touching rituals and mental rituals. One patient wouldn't touch the floor with anything but the soles of his shoes. Others would shower for hours or put on pants over and over again until they felt right. "They know it's senseless. They know it doesn't do anything for them, but if they don't do it they become very distraught and very uncomfortable and have a very difficult time functioning," Moreno said.
OCD symptoms develop as early as childhood but typically in the teen years. Over time the mental barriers make it hard for patients to lead normal, day-to-day lives.
Leslie Tolbert, UA vice president for research, graduate studies and economic development, said the university's Human Subjects Protection Program sets the rules for all research involving people to ensure the safety of participants and maximize the usefulness of the study. Psilocybin, like any other controlled substance, is heavily monitored.
Any further study of psilocybin at the UA would be federally funded and subject to review and oversight at that level as well, she said. "We don't have great treatments out there for OCD and any indication that there is a path to explore for something that would be effective seems an important thing to respond to," Tolbert said. "It's important that if psilocybin, perhaps in lower doses than are hallucinogenic, really has an impact, it's known. It's not a trivial question. There is a huge number of people who could benefit."
A few other researchers across the country have been involved in psilocybin research in the last several years, with some looking at the mystical experiences or sense of well-being associated with the drug, others examining its effect on patients with post-traumatic stress disorder and others examining it as a possible treatment for cluster headaches.
"Our study goes a little bit more in line with the use of pharmaceuticals to treat a bona fide clinical condition," Moreno said.
Read more about OCD causes, symptoms and treatments at go.azstarnet.com/ocd
"I don't want to characterize it as psychedelics are the way to go. Although it seemed to be safe, this was done in the context of supervision by trained professionals in a medical setting."