Status:
COMPLETED
Effects of Psilocybin in Advanced-Stage Cancer Patients With Anxiety
Lead Sponsor:
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Collaborating Sponsors:
Heffter Research Institute
Conditions:
Anxiety
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
Brief 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 psy...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00302744
Start Date
April 1 2004
End Date
December 1 2008
Last Update
March 13 2025
Active Locations (1)
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1
Harbor-UCLA Medical Center
Torrance, California, United States, 90509