Psychopharmacology of Psilocybin in Cancer Patients
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00465595 |
Recruitment Status :
Completed
First Posted : April 25, 2007
Results First Posted : July 19, 2018
Last Update Posted : July 19, 2018
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Sponsor:
Johns Hopkins University
Collaborator:
Heffter Research Institute
Information provided by (Responsible Party):
Johns Hopkins University
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Supportive Care |
Conditions |
Depressive Symptoms Anxiety Cancer |
Intervention |
Drug: psilocybin |
Enrollment | 56 |
Participant Flow
Recruitment Details | Participants were recruited through flyers, internet, and physician referral. |
Pre-assignment Details |
Arm/Group Title | Low-Dose First | High-Dose First |
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The Low-Dose-1st Group received the low dose of psilocybin on the first session and the high dose on the second session. | The High-Dose-1st Group received the high dose on the first session and the low dose on the second session. |
Period Title: Overall Study | ||
Started | 27 | 29 |
Completed | 22 | 24 |
Not Completed | 5 | 5 |
Baseline Characteristics
Arm/Group Title | Low-Dose First | High-Dose First | Total | |
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The Low-Dose-1st Group received the low dose of psilocybin on the first session and the high dose on the second session. | The High-Dose-1st Group received the high dose on the first session and the low dose on the second session. | Total of all reporting groups | |
Overall Number of Baseline Participants | 25 | 26 | 51 | |
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[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 25 participants | 26 participants | 51 participants | |
56.1 (11.5) | 56.5 (9.18) | 56.3 (9.99) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 25 participants | 26 participants | 51 participants | |
Female |
12 48.0%
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13 50.0%
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25 49.0%
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Male |
13 52.0%
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13 50.0%
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26 51.0%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 25 participants | 26 participants | 51 participants | |
American Indian or Alaska Native |
0 0.0%
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0 0.0%
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0 0.0%
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Asian |
1 4.0%
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0 0.0%
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1 2.0%
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Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
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0 0.0%
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Black or African American |
1 4.0%
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1 3.8%
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2 3.9%
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White |
23 92.0%
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25 96.2%
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48 94.1%
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More than one race |
0 0.0%
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0 0.0%
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0 0.0%
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Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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Education
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 25 participants | 26 participants | 51 participants | |
High School |
1 4.0%
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0 0.0%
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1 2.0%
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College |
8 32.0%
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15 57.7%
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23 45.1%
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Post-graduate |
16 64.0%
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11 42.3%
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27 52.9%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Roland R. Griffiths, Ph.D., Principal Investigator |
Organization: | Johns Hopkins University School of Medicine |
Phone: | 4105500034 |
EMail: | rgriff@jhmi.edu |
Responsible Party: | Johns Hopkins University |
ClinicalTrials.gov Identifier: | NCT00465595 |
Obsolete Identifiers: | NCT00850967 |
Other Study ID Numbers: |
NA_00001390 Johns Hopkins IRB5 NA_00001390 |
First Submitted: | April 23, 2007 |
First Posted: | April 25, 2007 |
Results First Submitted: | January 26, 2017 |
Results First Posted: | July 19, 2018 |
Last Update Posted: | July 19, 2018 |