Qualified researchers who wish to develop a clinical protocol employing a psychedelic are encouraged to contact our Medical Director, George Greer, M.D. at george@newmexico.com for further information. Researchers with approved protocols supported by the institute may be able to assist you in developing your own protocol and in obtaining the various approvals necessary to carry out clinical studies. They generally are willing to share relevant information from their protocols to the extent that it does not jeopardize their own research program.
I. Clinical Research
Harbor-UCLA Psilocybin and Cancer Study
This is the first psychedelic treatment with terminally ill patients since the early 1970's. The study examines the use of psilocybin in a controlled setting to reduce the psychospiritual anxiety, depression, and physical pain of terminal cancer patients. As a society we spend a great deal of attention treating cancer, but very little treating the human being who is dying of cancer. This study treats the whole human being. It aims to help the patient move towards a 'good' death, and help the patient's family deal well with the dying process of their loved one. If we can learn to work more skillfully with dying, we will also learn to take better care of life.
The study of 12 subjects has been completed and is being submitted for publication. Dr. Charles Grob, M.D., a Heffter founder, is directing the project.
Click here to see an interview with one of the patients, Pam Sakuda.
The primary objective of this double-blind, placebo-controlled pilot study is to assess the efficacy of psilocybin on psychosocial distress, with the specific primary outcome variable being anxiety associated with advanced cancer. Secondary outcome measures will look at the effect of psilocybin on symptoms of pain perception, depression, existential/psychospiritual distress, attitudes toward disease progression, quality of life, and spiritual/mystical states of consciousness.
Although the outcome measures will be similar to those used in the Harbor-UCLA study run by Dr. Grob, the proposed dose of psilocybin will be somewhat higher at 0.3mg/kg and the total subjects for this study will be 32 instead of 12. Stephen Ross, M.D., is the Principal Investigator of this project and subject enrollment began in April, 2009. For more information and details regarding this study or to discuss the referral of a patient, please call Krystallia Kalliontzi, M.Sc., Clinical Research Coordinator, at (212) 998-9252 or by email at kk71@nyu.edu
The Johns Hopkins University Psilocybin and Cancer Study
44 cancer patients will receive psilocybin treatment similar to that in Dr. Grob's study, except that it includes early-stage cancer patients and a different research design. This study specifically focuses on spiritual experience facilitated by psilocybin as a healing factor in patients who are psychologically distressed by their cancer diagnosis. Patients with and without disease progression are eligible. Outcome measures include measures of mystical/spiritual experience, quality of life, anxiety, depressed mood, attitude about death, use of pain medication, and blood markers of stress and immune function. Subject recruiting is ongoing, and potential subjects can be referred to the study coordinator, Mary Cosimano at (410) 550-5990, or by email to: Roland Griffiths.
Psilocybin in the Treatment of Obsessive-Compulsive Disorder
This study is the first clinical use of a psychedelic in the United States in more than 30 years. All the patients were beyond the reach of standard treatments, and all responded well. One patient had symptom remission for weeks following one psilocybin session. The researchers have applied to the federal government's National Institutes of Health for funding for the next phase, an expanded study. This progress from a Heffter funded pilot study to larger studies with federal funding is what we hope to see in each of our American projects. This study shows a potential breakthrough treatment for obsessive-compulsive disorder, a recalcitrant disease that is the fourth most common outpatient psychiatric problem. The study was conducted by Dr. Francisco Moreno, M.D. at the University of Arizona Medical Center, and published in 2006.
II.
Basic Science Research Heffter Zürich Center Psilocybin-Serotonin Receptor
Research
A recent focus of the
Heffter Zürich Research Center has been an examination of serotonin 5-HT2A neuroreceptor dynamics
in the human brain following psilocybin, and its potential relevance for the
treatment of obsessive-compulsive spectrum disorders (OCSDs), including OCD
and eating disorders. The study is being carried out by Dr. Felix Hasler,
Ph.D. and Boris B. Quednow, under the direction of Heffter board member
Franz X. Vollenweider.
Initial studies involved synthesizing the positron-emitting tracer molecule [18F]-altanserin, which binds to brain serotonin 5-HT2A receptors. Using positron-emission tomography (PET), the location and density of these receptors can then be visualized in the living human brain. The picture on the left is a side view showing the 5-HT2A brain receptors where psilocybin acts. The receptor
density is correlated with color, where red/yellow are the highest receptor
concentrations.
Administration of psilocybin can completely prevent the binding of the radioactive tracer to this area. Preliminary analysis reveals a strong and consistent decrease (30%) of [18F]-altanserin binding
in the psilocybin condition as compared to placebo.
When the actual
clinical study of psilocybin in OCSD patients begins, our Zürich group will
have the baseline data to show the normal levels of 5-HT2A receptors in the brain
and how psilocybin affects them. Those data will be essential to compare
with OCSD patients to gain an understanding of how psilocybin could be an
effective treatment. These are the first steps toward demonstrating a
mechanism for how psilocybin might help patients with OCD, following up on
the pilot study we supported at the University of Arizona, above. We now plan to move toward the biologically-related but
difficult to treat problem of eating disorders.
In the other major Zürich study, comparing subjects in a
meditation state with subjects under the influence of psilocybin, 3-D EEGs
showed striking similarities between the two states of consciousness. This
result may further explain how psilocybin “awakens” the brain patterns that
occur during meditative and spiritual states of consciousness.
The Johns Hopkins University Psilocybin
and Spirituality Study
This study is
a follow-up to their widely publicized project published last year by Dr.
Roland Griffiths and colleagues: Psilocybin can
occasion mystical-type experiences having substantial and sustained
personal meaning and spiritual significance.This
follow-up phase follows the same model as the first study, but uses different
doses of psilocybin.It was
funded by an anonymous donor to the Heffter Research Institute. We are
proud to have been a critical part of this groundbreaking research to
demonstrate the benefits of psychedelics to humanity.
III. Preclinical Research
Although there are no funded grants for preclinical research at this time, and most of the preclinical research is being carried out either by board members, or in the laboratories of our scientific advisors. For example, board members Drs. Mark Geyer and David Nichols continue to study the neuropharmacology of psychedelic agents. Dr. Geyer is a world-renowned authority on behavioral measures of effects of psychoactive drugs on cognitive processing in both animals and humans. In particular, his research involves a strong component of translational research, where models are being developed that may be predictive of cognitive dysfunction in human disease states such as schizophrenia. He also collaborates closely with Board member Dr. Franz Vollenweider at the Heffter Zurich Research center.
Dr. Nichols continues to study the molecular aspects of these substances. Most recently, his laboratory has been developing molecular models of the serotonin receptors using computational approaches, and is studying how various ligands, such as LSD, can bind to these receptors. Those studies are coupled with specific mutations in the receptor proteins to validate the virtual computational studies. His laboratory also is studying how different serotonin receptor activating molecules (agonists) can produce unique biochemical signals within brain neurons. He and his coworkers now have identified a unique pharmacological property of LSD that may be relevant to understanding schizophrenia, as well as certain altered states of consciousness.
One of our scientific advisors, Dr. Charles Nichols, carried out the first microarray analysis of gene expression changes produced in rodents following short and long term LSD administration. He and his coworkers have identified a number of important genes that are involved in regulating neuronal plasticity, suggesting that these substances may have long-ranging effects on brain function. His work is also translational, in that he anticipates identifying genes that may be involved in cognitive processes and altered states of consciousness, as well as in certain psychiatric disorders.
