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Effects of Psilocybin in Advanced-Stage Cancer Patients With Anxiety

Phase 1
18 Years
70 Years
Not Enrolling

Thank you

Trial Information

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.

Inclusion Criteria:

- Have advanced-stage cancer and anxiety.

- Be between the ages of 18 - 70.

Note: The location for the two treatment sessions is Los Angeles, California. Treatment
sessions are scheduled three to six weeks apart, and they include one overnight hospital
stay both times.

Exclusion Criteria:

- Not have cancer that affects the central nervous system or brain function.

- Have no history of major psychiatric disorder.

- Have no kidney disease, abnormal liver functions, epilepsy, or cardiovascular
disease, including untreated hypertension.

- Not be taking insulin, oral hypoglycemic, anti-seizure, or cardiovascular
medications (except anti-hypertensive drugs).

- May take PRN benzodiazepines up to 3 days before the session.

- No Prozac for the previous 5 weeks.

- No medications the day of and the day after treatment sessions, except may take
ongoing adjuvant chemotherapy as prescribed, prescribed or over-the-counter
non-narcotic pain medication at any time, and narcotic pain medications up to eight
hours before administration of psilocybin and six hours after administration.

- No alcohol consumption the day before, the day of, and the day after a session.

- Female subjects of childbearing potential must have a negative pregnancy test and
agree to use an effective form of birth control.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:


Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

Charles S. Grob, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, Los Angeles


United States: Food and Drug Administration

Study ID:




Start Date:

April 2004

Completion Date:

December 2008

Related Keywords:

  • Anxiety
  • Anxiety
  • Depression
  • Mood
  • Cancer
  • Quality of Life
  • Psychiatric
  • Psilocybin
  • Alternative
  • Los Angeles
  • Anxiety Disorders



Harbor-UCLA Medical Center Torrance, California  90509