ISSUE
     
Research in Focus
Novel NYU Study Uses Psychoactive Agent to Promote Enhanced Well-Being for Cancer Sufferers
 


Faculty and staff leading the study, seated from left: Dr. Emily Horowitz, Dr. Jeffry Guss, Dr. Patricia Corby, Dr. Stephen Ross, Dr. Anthony Bossis, Dr. Todd Bresnick, Ms. Katherine Maddox, Ms. Krystallia Kalliontzi








The NYU Langone School of Medicine and the Bluestone Center for Clinical Research at the NYU College of Dentistry are collaborating on a novel pilot study to investigate the potential therapeutic efficacy of the psychoactive agent, psilocybin, on the anxiety, psychosocial distress, and existential or spiritual suffering associated with a diagnosis of advanced-stage cancer. NYU is one of three sites in the U.S. conducting similar studies. The other two sites are the Johns Hopkins University School of Medicine and the UCLA David Geffen School of Medicine.

Studies indicate that two-thirds of all cancer patients suffer emotional distress and hopelessness following a cancer diagnosis; conversely, enhanced spiritual well-being has been associated with decreased hopelessness and a decreased desire for hastened death in patients with advanced-stage cancer.

Psilocybin has been used in various religious and cultural traditions for millennia to induce mystical or spiritual states of consciousness and well-being; however little is known scientifically about its long-term effects. A serotonergic agonist, psilocybin is the primary psychoactive compound of a group of mushrooms known as Psilocybe, and its actions are mediated predominantly at serotonin 5-HT 2A/C receptor sites.

According to the NYU study's principal investigator, Stephen Ross, MD, Assistant Professor of Psychiatry at the NYU School of Medicine and of Oral and Maxillofacial Pathology, Radiology and Medicine at the NYU College of Dentistry, "While there is literature from the 1950s to the early 1970s suggesting that patients with advanced cancer who were treated with psilocybin showed diminished anxiety, depression, and pain and an increase in well-being, research on the therapeutic uses of psilocybin in cancer patients has lagged because the political and cultural tumult of the period led to the inevitable shutdown of clinical research using hallucinogens. Now, after almost three decades of inactivity, the hallucinogen treatment model is again being examined in formal clinical settings."

A recent landmark study from Johns Hopkins University School of Medicine, published in 2006 and involving 36 normal volunteers who were hallucinogen na´ve, showed that psilocybin can be safely administered in a controlled research setting and can reliably occasion mystical-type experiences associated with considerable personal and spiritual meaning and sustained improvements in psychological functioning and well-being at 14-month follow-up. The link between mystical experiences, transformation, and sustained positive changes in psychological functioning was strongly suggested in multiple research studies during the 1960s. One such notable study took place in a government-funded study at the Spring Grove Psychiatric Center in Maryland, where two-thirds of 100 subjects receiving a serotonergic hallucinogen similar to psilocybin reported moderate to marked improvement in anxiety and acceptance of death associated with terminal cancer.

Similar results have been obtained from a recently completed double-blind, placebo-controlled longitudinal study at UCLA involving 12 patients with terminal cancer and psychological distress who also experienced mystical feelings endowed with significant personal meaning following administration of psilocybin with a trend toward improvements in anxiety and depression reported. An article reporting the results of the UCLA study has been submitted to the Archives of General Psychiatry and is under review.

Dr. Ross, who is also Director, Division of Alcoholism and Drug Abuse, NYU/Bellevue Hospital Center, and Director, Clinical Core, NYU Langone Center of Excellence on Addiction, adds, "As an addiction psychiatrist, I see parallels between the lack of training, education, and general attention paid to addiction and end-of-life distress and palliative care. We clearly need new paradigms of care to address the enormous psychological suffering that can occur in patients with advanced cancer for which traditional medicine offers little to help counter the emotional distress of dying."

The NYU study, an FDA- and DEA- approved phase I, double-blind, controlled study, is open to patients between 18 and 76 years of age who have been diagnosed with potentially life-threatening, advanced or recurrent cancer and who have anxiety-spectrum disorders associated with the diagnosis, including adjustment disorder, anxiety disorder due to cancer, acute stress disorder, and generalized anxiety disorder. Questionnaires and interviews are used to evaluate multiple outcome variables, including the effects of the study drug on anxiety, depression, quality of life, pain perception, spirituality, and attitude toward advanced illness.

In addition to two drug administration sessions seven weeks apart, volunteers in the NYU study receive extensive psychotherapy. Both the drug administration and psycho-therapy sessions take place at the Bluestone Center, in a room that has been specially designed to foster a sense of serenity and spiritual well-being. As in the studies at Johns Hopkins University and UCLA, patients in the NYU study report mystical-type experiences having substantial personal meaning and spiritual significance. As one patient put it, "This study has been a gift for me. I want to repeat the psilocybin session."

"This fits nicely with the proposed hypothesis of how psilocybin might work," says Dr. Ross. "These agents have been reported to increase spiritual states, specifically connected with a higher power, including enhanced ability for insight and changing fixed ideas."