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Psychopharmacology of Psilocybin in Cancer Patients

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ClinicalTrials.gov Identifier: NCT00465595
Recruitment Status : Completed
First Posted : April 25, 2007
Results First Posted : July 19, 2018
Last Update Posted : July 19, 2018
Sponsor:
Collaborator:
Heffter Research Institute
Information provided by (Responsible Party):
Johns Hopkins University

Study Type Interventional
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
Recruitment Details Participants were recruited through flyers, internet, and physician referral.
Pre-assignment Details  
Arm/Group Title Low-Dose First High-Dose First
Hide Arm/Group Description 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
Arm/Group Title Low-Dose First High-Dose First Total
Hide Arm/Group Description 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
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
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
Number Analyzed 25 participants 26 participants 51 participants
Female
12
  48.0%
13
  50.0%
25
  49.0%
Male
13
  52.0%
13
  50.0%
26
  51.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 26 participants 51 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   4.0%
0
   0.0%
1
   2.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   4.0%
1
   3.8%
2
   3.9%
White
23
  92.0%
25
  96.2%
48
  94.1%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Education  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 26 participants 51 participants
High School
1
   4.0%
0
   0.0%
1
   2.0%
College
8
  32.0%
15
  57.7%
23
  45.1%
Post-graduate
16
  64.0%
11
  42.3%
27
  52.9%
1.Primary Outcome
Title GRID-HAM-D-17 -- Structured Interview Guide for the Hamilton Depression Scale.
Hide Description The GRID-Hamilton Depression Rating Scale is a 17-item clinician-administered rating scale designed to assess severity of depressive symptoms. The score range for the GRID-HAMD is 0 to 52, with higher score indicating more severe depression. For this clinician-rated measure, a clinically significant response was defined as ⩾50% decrease in measure relative to Baseline; symptom remission was defined as ⩾50% decrease in measure relative to Baseline and a score of ⩽7 on the GRID-HAMD
Time Frame Baseline, 5 weeks post session 1 and 2, 6-month follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low-Dose First Baseline Low-Dose First Post Session 1 Low-Dose First Post Session 2 Low-Dose First 6 Month High-Dose First Baseline High-Dose First Post Session 1 High-Dose First Post Session 2 High-Dose First 6 Month
Hide Arm/Group Description:
The Low-Dose-1st Group received the low dose of psilocybin on the first session and the high dose on the second session.
The Low-Dose-1st Group received the low dose of psilocybin on the first session and the high dose on the second session.
The Low-Dose-1st Group received the low dose of psilocybin on the first session and the high dose on the second session.
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.
The High-Dose-1st Group received the high dose on the first session and the low 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.
The High-Dose-1st Group received the high dose on the first session and the low dose on the second session.
Overall Number of Participants Analyzed 25 25 24 22 26 25 25 24
Mean (Standard Error)
Unit of Measure: units on a scale
22.32  (.88) 14.8  (1.45) 6.5  (.86) 6.95  (1.24) 22.84  (.97) 6.64  (1.04) 6.52  (1.44) 6.23  (1.3)
2.Primary Outcome
Title HAM-A Assessed With the SIGH-A -- a Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A).
Hide Description

The Hamilton Anxiety Rating Scale is a 14-item clinician-administered rating scale designed to assess severity of anxiety symptoms. The score range for the HAM-A is 0 to 56, with higher score indicating more severe anxiety.

For this clinician-rated measure, a clinically significant response was defined as ⩾50% decrease in measure relative to Baseline; symptom remission was defined as ⩾50% decrease in measure relative to Baseline and a score of ⩽7 on the GRID-HAM-A

Time Frame Baseline, 5 weeks post session 1 and 2, 6-month follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low-Dose First Baseline Low-Dose First Post Session 1 Low-Dose First Post Session 2 Low-Dose First 6 Month High-Dose First Baseline High-Dose First Post Session 1 High-Dose First Post Session 2 High-Dose First 6 Month
Hide Arm/Group Description:
The Low-Dose-1st Group received the low dose of psilocybin on the first session and the high dose on the second session.
The Low-Dose-1st Group received the low dose of psilocybin on the first session and the high dose on the second session.
The Low-Dose-1st Group received the low dose of psilocybin on the first session and the high dose on the second session.
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.
The High-Dose-1st Group received the high dose on the first session and the low 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.
The High-Dose-1st Group received the high dose on the first session and the low dose on the second session.
Overall Number of Participants Analyzed 25 25 24 22 26 25 25 24
Mean (Standard Error)
Unit of Measure: units on a scale
25.68  (.89) 16.64  (1.53) 8.92  (1.14) 7.95  (1.19) 25.73  (1.11) 8.48  (1.16) 7.52  (1.27) 7.04  (1.17)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Low Dose Condition (Group) High Dose Condition (Group)
Hide Arm/Group Description The experimental design of this study is a complete cross-over, with two groups of participants receiving the low and high doses of psilocybin in counterbalance order. The Low Dose Group is comprised of all low dose psilocybin sessions (n=50). The number of sessions is different from the total enrollment because of dropouts. The experimental design of this study is a complete cross-over, with two groups of participants receiving the low and high doses of psilocybin in counterbalance order. The High Dose Group is comprised of all high dose psilocybin sessions (n=50). The number of sessions is different from the total enrollment because of dropouts.
All-Cause Mortality
Low Dose Condition (Group) High Dose Condition (Group)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Low Dose Condition (Group) High Dose Condition (Group)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/56 (0.00%)   0/56 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Low Dose Condition (Group) High Dose Condition (Group)
Affected / at Risk (%) Affected / at Risk (%)
Total   10/56 (17.86%)   23/56 (41.07%) 
Cardiac disorders     
Elevated Systolic Blood Pressure  [1]  9/56 (16.07%)  16/56 (28.57%) 
Elevated Diastolic Blood Pressure  [2]  1/56 (1.79%)  7/56 (12.50%) 
General disorders     
Nausea   0/56 (0.00%)  7/56 (12.50%) 
Psychiatric disorders     
Anxiety Episode [3]  7/56 (12.50%)  13/56 (23.21%) 
Indicates events were collected by systematic assessment
[1]
systolic blood pressure higher than 160 at session timepoint
[2]
Diastolic blood pressure higher than 100 at session timepoint.
[3]
episode isolated to session
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Roland R. Griffiths, Ph.D., Principal Investigator
Organization: Johns Hopkins University School of Medicine
Phone: 4105500034
EMail: rgriff@jhmi.edu
Layout table for additonal information
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