Effects of Psilocybin in Advanced-Stage Cancer Patients With Anxiety
Condition: Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Psychiatric Research Study For Cancer Patients

      The Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center is conducting a
      study designed to measure the effectiveness of the novel psychoactive medication psilocybin
      on the reduction of anxiety, depression, and physical pain.
    

Detailed description: 
      The significance of this study is that it is addressing the important issues of psychological
      and spiritual well being of people who have advanced cancer. In 2001, the National Cancer
      Policy Board of the Institute of Medicine and National Research Council issued a report
      (Improving Palliative Care for Cancer: Summary and Recommendations) that specifically
      recommended research be conducted using novel agents and methods. Psilocybin is a novel agent
      which produces a profound alteration in your state of consciousness. It is the main active
      ingredient found in "magic mushrooms".

      Our specific aim is to learn whether this psychoactive drug, psilocybin, might be effective
      in reducing anxiety, depression and physical pain, and therefore improving your quality of
      life. This pilot study will start with 12 people ages 18-70. For each participant there will
      be two overnight admissions to the hospital. In one session you will be given a placebo and
      in the other you will get the active medication, but no one will know which drug is
      administered when. This is called a double blind study. You will be asked to fill out
      questionnaires about how you feel, your pain levels and your moods. There will also be at
      least two psychotherapy meetings before the study sessions, so that you are fully aware of
      what to expect and to have all your questions answered.

      We cannot take you in the study if you have central nervous system (CNS) cancers, kidney
      disease, diabetes, abnormal liver function tests, epilepsy, cardiovascular disease including
      untreated high blood pressure (BP greater than 140/90), and pregnancy. The psychiatric
      exclusions are: you or an immediate family member with a history of a major psychiatric
      disorder, a current substance abuse problem, or an anxiety or a mood disorder within 1 year
      prior to the onset of symptoms of your current illness.

      We also cannot take you in the study if you are taking certain medications, such as:
      anti-seizure, insulin and oral hypoglycemics, and cardiovascular drugs (except
      anti-hypertensive medications). Some antidepressant (SSRIs) medications cannot be taken
      within the two weeks prior to the session (except for Prozac, which cannot be taken in the
      last 5 weeks prior to the session).

      You will get a MRI of the brain prior to admission (if you haven't had one in the prior two
      months), at the study's expense, to be sure there is no CNS involvement. You can provide us,
      or the study will pay for, lab work from the prior 2 weeks (CBC, liver function and renal
      function). The history and physical, neurological exam, EKG, and a urine pregnancy test (if
      you are a woman with child-bearing potential), will be done on admission by the house staff
      doctors.

      You will be allowed to take your own medications while in the hospital, and will be
      encouraged to bring to the hospital personal photos, small memorabilia, and some of your
      favorite music that can be played during the sessions.
    

Intervention name(s): Psilocybin (drug); Active Niacin Placebo
Intervention type(s): Drug; Other
Intervention description(s): One placebo session (niacin) and one active drug session (.2 mg/kg). Treatment sessions are six hours.
Other intervention name(s): psilocybin
Intervention MeSH terms: Niacin; Psilocybin
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: Within-subject cross-over study. Each participant received active drug and active placebo on separate dates.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Anxiety; Depression; Mood; Cancer; Quality of Life; Psychiatric; Psilocybin; Alternative; Los Angeles