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Effects of Psilocybin in Advanced-Stage Cancer Patients With Anxiety

This study has been completed.
Sponsor:
Collaborator:
Heffter Research Institute
Information provided by (Responsible Party):
Los Angeles Biomedical Research Institute
ClinicalTrials.gov Identifier:
NCT00302744
First received: March 10, 2006
Last updated: January 28, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Anxiety
Drug: Psilocybin (drug)
Phase 1

Study Type: Interventional
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
Official Title: Effects of Psilocybin in Advanced-Stage Cancer Patients With Anxiety

Resource links provided by NLM:


Further study details as provided by Los Angeles Biomedical Research Institute:

Primary Outcome Measures:
  • Anxiety [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 12
Study Start Date: April 2004
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Each subject functions as their own control (one placebo session/one active drug session)
Drug: Psilocybin (drug)
One placebo session (niacin) and one active drug session (.2 mg/kg). Treatment sessions are six hours.
Other Name: psilocybin

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00302744

Locations
United States, California
Harbor-UCLA Medical Center
Torrance, California, United States, 90509
Sponsors and Collaborators
Los Angeles Biomedical Research Institute
Heffter Research Institute
Investigators
Principal Investigator: Charles S. Grob, MD University of California, Los Angeles
  More Information

No publications provided by Los Angeles Biomedical Research Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Los Angeles Biomedical Research Institute
ClinicalTrials.gov Identifier: NCT00302744     History of Changes
Other Study ID Numbers: HEFFTER11287-01
Study First Received: March 10, 2006
Last Updated: January 28, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Los Angeles Biomedical Research Institute:
Anxiety
Depression
Mood
Cancer
Quality of Life
Psychiatric
Psilocybin
Alternative
Los Angeles

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders
Psilocybine
Central Nervous System Agents
Hallucinogens
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014