Effects of Psilocybin in Advanced-Stage Cancer Patients With Anxiety
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
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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Charles S. Grob, MD
University of California, Los Angeles
United States: Food and Drug Administration
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