Some info by the Heffter Research institute...
Obsessive Compulsive Disorder Study
The first clinical research study with a hallucinogen in the United States in 30 years has begun. We?ve funded a study led by Dr. Francisco Moreno at the University of Arizona Medical School to look into whether psilocybin (which occurs naturally in ?magic mushrooms?) can be efficacious in the treatment of obsessive compulsive disorder (OCD). Several anecdotal reports have suggested that acute use of hallucinogens may lead to a profound reduction of symptoms. OCD is a relatively common condition: many researchers place it among the 4 most common psychiatric afflictions that outpatients seek treatment for in the United States. OCD appears to result from serotonin dysfunction. Current treatment relies on the Prozac-like ?selective serotonin re-uptake inhibitors (SSRI?s).? But these work well only for a relatively small percentage of patients. Psilocybin is a potent serotonin agonist, whose mechanism of action is altogether different from that of the SSRI?s.
Two important questions will be addressed in this study: 1) do potent hallucinogens lead to an acute decrease in the symptoms of OCD?; and 2) if so, is a full hallucinogenic dose required to demonstrate significant reduction in the symptoms of OCD? The study was of course fully approved by the federal government; a pharmaceutical company manufactured the psilocybin.
The first patients have received treatment with psilocybin, and the results appear promising. Our deep hope is that we may find that psilocybin, a non-toxic and naturally occurring substance, provides a breakthrough treatment for this widespread and debilitating condition.
Easing the Anxiety of Death
Early studies in the 1960s and 70s produced profoundly interesting results when hallucinogens were given to patients in their dying process. An overwhelming majority of them gained benefit from the treatment. Anxiety was reduced, and for many, physical pain diminished significantly. These results were a prime reason to start up the Heffter Institute in the first place, because they were the most well documented evidence of therapeutic value for hallucinogens.
According to a report issued in June 2001 by The National Cancer Policy Board of the Institute of Medicine and National Research Council, the medical establishment is fixated on finding a cure for cancer but is largely inattentive to the agony of cancer patients. According to the Board, American society must devote more resources toward helping the approximately 550,000 Americans dying annually of cancer, by focusing on palliative care, which addresses the relief of symptoms.
In other words, we must work actively to relieve the pain and suffering of those with cancer. Our new UCLA end-stage cancer study is precisely designed to do this. We plan to administer psilocybin to end-stage cancer patients, in a carefully controlled setting, to reduce their suffering. The study leader is Dr. Charles Grob of Harbor-UCLA Medical Center. Dr. Grob was the first researcher to conduct FDA-approved human research with 3,4-methylenedioxy-methamphetamine (MDMA). Dr. Grob?s extensive clinical experience will be particularly valuable for this work, because of the fragile emotional condition that end-stage cancer patients frequently experience.
The study focuses on whether anxiety in the dying can be significantly reduced by the appropriate administration of psilocybin. Any attendant reduction in pain will also be measured. The protocol has been submitted for FDA approval, and we hope to see the clinical phase begin in late 2002 or early 2003.
Swiss Heffter Research Center
Professor Franz Vollenweider at the University of Zurich continues to build an extensive and elegant program of research into the nature of consciousness, using hallucinogens as research tools. The importance of his work was recognized in an award in July 2002 from the British Association of Psychopharmacology. He now has a team of 8 people working with him on a series of co-ordinated studies. Let us look at two, so as to get a taste of his work.
The Swiss team is carrying out a study on the effects of low dose psilocybin on memory in human subjects between 50 and 65 years of age. They should learn about the effects of serotonergic agents in facilitating memory in this population for whom measurable memory deficits are an every day fact of life. This study will also be part of the Swiss team?s long-term project of investigating how memory is used to construct the human sense of self.
Moving to the clinical dimension, the Swiss team has developed a protocol to test the feasibility of using psilocybin in the treatment of anorexia and bulimia. These disorders may have an etiology similar to that of obsessive compulsive disorder. The thought, therefore, is that a serotonin agonist may also prove efficacious in their treatment. The design of this eating disorder study opens up the exciting possibility of running clinical studies in Switzerland in parallel with the powerful basic neuroscience studies that our Swiss colleagues are carrying out so adeptly.
LSD and Gene Expression within the Mammalian Brain
Despite research over the past 30 years, the mechanism of action of hallucinogenic drugs remains largely a mystery. Research has primarily focused on how the drugs affect neurotransmitters. A team of researchers at Vanderbilt University School of Medicine, including Dr. Elaine Sanders-Bush and Dr. Charles Nichols and jointly funded by Heffter and the National Institutes of Health, has now for the first time used state of the art functional genomic and molecular methods to investigate the brain?s genetic response to LSD.
The investigators began with the question whether some behaviors elicited by hallucinogens are the result of temporary changes in gene expression in the brain. They used the powerful technology of DNA microarrays?small glass slides, about thumbnail sized, that have about ten thousand gene sequences printed onto them using actual DNA. Each of these sequences represents a unique gene. The researchers have already screened one chip of 10,000 and are in the process of screening a second chip with another 10,000 genes. Because the predicted size of the number of genes in a human is only 30-40,000, a gene ?chip? may represent nearly one third of the genome.
Results to date show that LSD induces expression changes in a relatively small but important collection of genes. Many of these genes influence the way neurons change physically to alter functional abilities. These genes may thus play a role in learning and the storage of memories. By combining these results with current signal transduction mechanisms, electrophysiology, and behavioral experiments, we may finally begin to grasp the larger picture of how the effects of hallucinogens are produced at the molecular level. This will in turn help us understand the physical substrate of cognition.
Clinical Investigations of the Therapeutic Applications of Ayahuasca in Human Subjects
The recent success of the nutraceutical industry demonstrates that the public is interested in healing through botanical formulations. Yet the healing properties of the most powerful, ancient, and interesting botanicals have not been clinically studied by Western medicine. In a new project led by Dr. Dennis McKenna at the University of Minnesota Medical School, we propose to do all the work needed to make clinical studies with ayahuasca?a potent hallucinogenic traditional plant medicine from the Amazon?possible in this country. Such studies should lead in time to the recognition and use of ayahuasca within medical practices, in conjunction with appropriate adjunct therapies. The work prior to clinical studies is extensive. It is primarily of two types: formulating a standard extract for research purposes, and gaining all the needed governmental approvals. This will take at least a year of work, well worth the effort to gain the freedom to medically explore the healing powers of this fascinating plant medicine. This project is now in the design phase; if we find the needed funds, much will happen.
Long-term Effects of Peyote Use
Although we believe that hallucinogens have real potential to provide medical benefits, there is an important threshold question: what would the human health impacts be of using these substances over a long period of time? Even if they are medically valuable in the short term, might there be long-term consequences of concern?
We have been working to answer these questions with a team of researchers at the McLean Hospital, a teaching hospital of The Harvard Medical School. With funding from Heffter, they are studying the effects of peyote use in members of The Native American Church. In their religious services, church members legally consume peyote, which contains the potent hallucinogen mescaline. They often consume large quantities over a period of many years. Thus they offer an excellent test case for studying the health effects of long-term hallucinogen use.
The point of the study is to measure, with a variety of sensitive techniques, what effects the long-term-peyote use may have had. The initial results suggest that there are no cognitive deficits, nor any physical or psychological problems from church members? use of peyote. If this is the ultimate finding, it will be an important foundation for the medical use of hallucinogens.
Addiction Treatment: Heroin
Heffter has for several years been working with and funding a group of addiction researchers in Russia, at The St. Petersburg Center of Addictions, led by Dr. Evgeny Krupitsky. They have done excellent studies on the use of hallucinogen-assisted psychotherapy in the treatment of alcohol addiction. Last year, they completed a study of hallucinogen-assisted psychotherapy for the treatment of heroin addiction. Patients who received a single session of this treatment showed remarkable improvement: approximately 70% were abstinent two months after the session. So it appears that hallucinogen-assisted psychotherapy provides temporary but effective anti-addictive benefits for a period of time lasting one or two months. This new project looks into how to extend these befits for longer periods of time.
Repeated dosing at the appropriate intervals may give an addict a sustainable, steady improvement in overall adjustment and level of functioning. With funding from Heffter, this multiple dose study is now underway. A three-year effort, it should produce valuable initial results this year.
Conclusion
This is shaping up to be an important year for the Institute. I look forward to sharing news of our findings with you, ones that will lead to a deeper understanding of how the mind works, and improve the lot of people who are suffering from a variety of medical conditions.
-------------------- There's a thin line between sanity and insanity... and I just snorted it.
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