Psilocybin Cancer Anxiety Study
Condition: Cancer
Study type: Interventional
Phase: Early Phase 1

Summary: 
      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.
    


Intervention name(s): Psilocybin; Niacin
Intervention type(s): Drug; Drug
Intervention description(s): Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg; Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg
Other intervention name(s): 4-phosphoryloxy-N,N-dimethyltryptamine
Intervention MeSH terms: Niacin; Psilocybin; N,N-Dimethyltryptamine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cancer; Anxiety; Depression; Hallucinogens