Stress, anxiety and depression easily mounts with a cancer diagnosis. The fears, uncertainties, and doubts can reign supreme, making cancer patients feel debilitated. Clinical sponsors are increasingly looking to what have traditionally been taboo substances to explore how to provide long-term relief to these patients. In many cases, it is the humane thing to do. At least that is what Dr. Stephen Jones, associate professor of psychiatry in the Department of Psychiatry at NYU Langone, believes.
NYU Langone’s Jones became part of a small but growing movement of major research institutions, opening up the possibility of psychedelics for use in health care.
The primary objective of this double-blind, placebo-controlled pilot study was to assess the efficacy of psilocybin administration (4-phosphoryloxy-N,N-dimethyltryptamine), a serotonergic psychoactive agent, on psychosocial distress, with the specific primary outcome variable being anxiety associated with cancer.
The New York-based study team sought to assess secondary measures such as the effect of psilocybin on symptoms of pain perception, depression, existential/psychospiritual/mystical states of consciousness. Another objective was to better understand the safety, patient recruitment, consent for treatment, and retention. The duration of the proposed investigation was sufficiently lengthy to administer the drug one time to each of thirty-two patients, and conduct follow-up assessments.
The Grob Study
This study in New York was separate but similar to recently completed study at the Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center—conducted by Dr. Charles Grob, a psychiatrist. The outcomes measures are similar to the Grob study, the psilocybin dose is higher at 0.3 mg/kg and the total subjects for the study would be 32 instead of 12.
Reviewed by IRBs
This psilocybin study was approved by the Bellevue Psychiatry Research Committee, the NYU Oncology PRMC Committee, the Food and Drug Administration (FDA) through the issuance of an IND, the New York University School of Medicine Institutional Review Board (NYU IRB), the Health and Hospitals Corporation (HHC)—New York University (NYU) Clinical Translational Science Institute (CTSI), the NYU Bluestone Center for Clinical Research and the Drug Enforcement Agency (DEA through the issuance of a schedule I license.
Published in the Journal of Psychopharmacology, the study team found that a single doze of psilocybin provides long-term relief of anxiety and depression in cancer patients reports WQAD. It was reported that the participants who were given psilocybin reported less anxiety, depression, hopelessness, demoralization and death anxiety more than four years after receiving the dose in combination with psychotherapy.
Building on improvement first reported by the team in 2016, 29 patients with cancer-related anxiety and depression were administered a single dose of psilocybin or a vitamin placebo called niacin. Several weeks later, they were given the opposite treatment—in combination with nine psychotherapy sessions.
Dr. Stephen Ross noted, “Our findings strongly suggest that psilocybin therapy is a promising means of improving the emotional, psychological, and spiritual well-being of patients with life-threatening cancer.”
After 6 ½ months about 60% to 80% of the patients evidenced clinically significant reductions in depression, anxiety and existential distress not to mention less stress about death. 15 of the original patients revealed sustained, long-term improvements after periods of study ranging from 3.2 to 4.5 years—over 70% of these patients attributed positive life changes to the therapy experience.
Limitations of the Study
As with many studies, there are inherent limitations as in the number of participating patients observed and monitored in this latest trial and its dovetailing with the first study. James Rucker, head of Psychedelic Trials Group at the Centre for Affective Disorders at Kings College London in the UK, noted some of the constraints of this study, such as the fact that it was “limited because the original trial was a crossover design.” He continued, “This means that in the original trial every trial participant eventually received psilocybin. Because of this, there is no control group in this current study. This means that we do not know whether the participants might have improved long term anyway, regardless of treatment.”
An Alternative for Treatment of Cancer Patients with Anxiety
Dr. Ross continued, “This approach has the potential to produce a paradigm shift in the psychological and existential care of patients with cancer, especially those with terminal illness.” It could very well be that a psilocybin approach could be an important alternative means of treating anxiety and depression among cancer patients, which is urgently needed.
Gabby Agin-Liebes, led investigator and lead author of the long-term follow-up study and co-author of the 2016 parent study, noted, “These results may shed light on how the positive effects of a single dose of psilocybin persist for a long time.” She continued, “The drug seems to facilitate a deep, meaningful experience that stays with a person and can fundamentally change his or her mindset and outlook.”
As it turns out multiple studies have evidenced some benefits for using psilocybin applied as a therapy with depression in combination with supportive therapy. This could benefit many of the estimated 18 million people worldwide battling with cancer—many of who will sink into bouts of depression and anxiety.
Dr. Stephen Ross, associate professor of psychiatry in the Department of Psychiatry at NYU Langone
Gabby Agin-Liebes, lead investigator and lead author
Call to Action: Do you or a loved one have a cancer diagnosis and face significant anxiety and/or depression? Share these findings with your physicians. If you would like us to invite Dr. Ross on to the TrialSite News Podcast Series for an interview, let us know.