Psilocybin Cancer Anxiety Study

The primary objective of this double-blind, placebo-controlled pilot study is 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. Secondary outcome measures will look at the effect of psilocybin on symptoms of pain perception, depression, existential/psychospiritual distress, attitudes towards disease progression and death, quality of life, and spiritual/mystical states of consciousness.

Status Completed
Results Published Yes
Start date 02 January 2009
End date 09 June 2018
Chance of happening 100%
Phase Phase I
Design Blinded
Type Interventional
Participants 29
Sex All
Age 18- 76
Therapy No

Trial Details

In addition, a secondary objective of the study is to determine the feasibility of administering psilocybin to this patient population, with regards to the following issues: safety, patient recruitment, consent for treatment, and retention. The duration of the proposed investigation will be long enough to administer the drug one time to each of thirty-two patients and to conduct follow-up assessments. This study is separate but similar to a recently completed study at the Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, run by a psychiatrist, Dr. Charles Grob. Although the outcomes measures would be similar to those used as in the Grob study, the proposed dose of psilocybin is higher at 0.3mg/kg and the total subjects for the study would be 32 instead of 12. The study utilizes a cross-over design at 7 weeks and includes prospective follow-up of 6 months duration. This study has been approved by the Bellevue Psychiatry Research Committee, the NYU Oncology PRMC Committee, the Food and Drug Administration (FDA) through the issuance of an IND (77,138), 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. It is hypothesized that a one time experience with psilocybin will occasion dramatic shifts in consciousness and awareness that will lead to short-term (ie hours to days) and long-term (up to 6 months in this study, following the administration of the second dosing, either psilocybin or placebo) improvement in anxiety, depression, and pain associated with advanced cancer. The exact mechanism of action is unclear but based on studies done in the 60's using serotonergic hallucinogens in patients with advanced cancer, improvements in anxiety levels, mood and pain were reported. However, a treatment model developed by the famous British psychiatrist Humphrey Osmond, offers one possibility. In this model, serotonergic hallucinogens' therapeutic mechanism lies in their ability to allow the individual to access novel dimensions of consciousness and their efficacy or lack thereof relies on whether a transcendent and mystical state of awareness is attained. Another possible mechanism relates to what Dobkin de Rios and Grob have described as 'managed altered states of consciousness,' where the power of suggestibility, occurring in a safe setting, allows one to transcend a particular state of consciousness (i.e. anxiety and depression associated with advanced illness) as a means to facilitate emotional discharge and to manage irreconcilable conflict.

NCT Number NCT00957359

Sponsors & Collaborators

NYU Langone Health
This company doesn't have a full profile yet, it is linked to a clinical trial.


Patient Experiences of Psilocybin-Assisted Psychotherapy: An Interpretative Phenomenological Analysis
This qualitative analysis of experiences may help form new hypotheses on why a psychedelic experience works. Found is that participants experienced strong emotions, partly conveyed by music.

Long-term follow-up of psilocybin-assisted psychotherapy for psychiatric and existential distress in patients with life-threatening cancer
This is a follow-up study (n=16) at an average of 3.8 years after a single dose of psilocybin, combined with psychotherapy, for patients suffering from cancer-related existential distress. Approximately 60-80% of participants experienced reduced anxiety or depressive symptoms. This adds to the body of research that indicates that the positive of a guided psychedelic experience can be long-lasting.

Rapid and sustained symptom reduction following psilocybin treatment for anxiety and depression in patients with life-threatening cancer: A randomized controlled trial
This double-blind placebo-controlled study (n=29) for those suffering from anxiety and depression, related to cancer, improved significantly (60-80% of participants) after a single dose of psilocybin (21mg/70kg) in combination with psychotherapy.

Measures Used

Hamilton Anxiety Scale
The Hamilton Anxiety Scale (HAM-A) was one of the first rating scales developed to measure the severity of anxiety symptoms and is still widely used today in both clinical and research settings.

State-Trait Anxiety Inventory
The State-Trait Anxiety Inventory (STAI) is a commonly used measure of trait and state anxiety. The STAI measures two types of anxiety – state anxiety, anxiety about an event, and trait anxiety, anxiety level as a personal characteristic.

Data attribution

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