Psychopharmacology of Psilocybin in Cancer Patients

• 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: Johns Hopkins University
• 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

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
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

Baseline Characteristics

Arm/Group Title		Low-Dose First	High-Dose First	Total
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
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%

Outcome Measures

1. Primary Outcome

Title	GRID-HAM-D-17 -- Structured Interview Guide for the Hamilton Depression Scale.
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

Outcome Measure Data

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
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).
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

Outcome Measure Data

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
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)

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Low Dose Condition (Group)	High Dose Condition (Group)
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	--/--	--/--
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%)
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

Limitations and Caveats

[Not Specified]

More Information

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

• Name/Title: Roland R. Griffiths, Ph.D., Principal Investigator
• Organization: Johns Hopkins University School of Medicine
• Phone: 4105500034
• EMail: rgriff@jhmi.edu

Publications of Results:

Griffiths RR, Johnson MW, Carducci MA, Umbricht A, Richards WA, Richards BD, Cosimano MP, Klinedinst MA. Psilocybin produces substantial and sustained decreases in depression and anxiety in patients with life-threatening cancer: A randomized double-blind trial. J Psychopharmacol. 2016 Dec;30(12):1181-1197. doi: 10.1177/0269881116675513.

• 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