Psilocybin Cancer Anxiety Study
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. 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.
Inclusion Criteria:

 -  Age: 18-76

 -  Current or historical diagnosis of cancer

 -  Projected life expectancy of at least one year

 -  DSM-IV diagnoses: Acute Stress Disorder, Generalized Anxiety Disorder, Anxiety
 Disorder due to cancer, Adjustment Disorder with anxious features

 -  Any stage of cancer diagnosis

 Exclusion Criteria:

 -  Epilepsy

 -  Renal disease

 -  Diabetes

 -  Abnormal liver function

 -  Severe cardiovascular disease

 -  Malignant Hypertension

 -  Baseline blood pressure must be less than or equal to 140/90

 -  Personal history or immediate family members with schizophrenia, bipolar affective
 disorder, delusional disorder, schizoaffective disorder or other psychotic spectrum
 illness

 -  Current substance use disorder

 -  Medication contraindications: anti-seizures medications, insulin, oral hypoglycemics,
 clonidine, aldomet, cardiovascular medications, anti-psychotics (first and second
 generation), anti-depressants and mood stabilizers