Psychopharmacology of Psilocybin in Cancer Patients

Phase 2

Completed

• Conditions: Depressive Symptoms; Anxiety; Cancer
• Interventions: Drug: psilocybin

• Registration Number: NCT00465595
• Lead Sponsor: Johns Hopkins University

Brief Summary

This research is being done to study the psychological effects of psilocybin in cancer patients. Psilocybin is a naturally occurring substance found in some mushrooms that some cultures have used for centuries in religious practices.

Detailed Description

This research is being done to study the psychological effects of psilocybin in cancer patients. Psilocybin is a naturally occurring substance found in some mushrooms that some cultures have used for centuries in religious practices. Psilocybin has not been approved for general medical use by the U.S. Food and Drug Administration (FDA). Its use in this study is investigational. Psilocybin is a mood-altering drug with effects similar to other hallucinogens like LSD and mescaline. Mescaline is the main psychoactive component of the peyote cactus used in Native American religious practices. Such substances have been used for centuries in some cultures as a way of inducing non-ordinary states of consciousness for religious and spiritual purposes.

An earlier study that was done in our lab with healthy participants found that psilocybin, given in a comfortable and supportive setting, can provide an experience that is personally and spiritually meaningful for the participant. This study is being done to find out if psilocybin can also produce personally and spiritually meaningful experiences in cancer patients. This could be important because spirituality has been associated with increased psychological coping and decreased depression in serious illness. People with a diagnosis of cancer between the ages of 21 and 80 years old and who meet the medical requirements may join. About 44 people are expected to take part in this study.

Study Timeline

• Study Start: 2007-04
• Study First Submitted: 2007-04-23
• Study First Submitted QC: 2007-04-23
• Study First Posted: 2007-04-25
• Primary Completion: 2014-12
• Study Completion: 2016-12
• Results First Submitted: 2017-01-26
• Status Verified: 2018-06
• Results First Submitted QC: 2018-06-19
• Last Update Submitted: 2018-06-19
• Results First Posted: 2018-07-19
• Last Update Posted: 2018-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Low Dose First, High Dose Second	psilocybin	The Low-Dose-1st Group received the low dose of psilocybin on the first session and the high dose on the second session
High Dose First, Low Dose Second	psilocybin	The High-Dose-1st Group received the high dose of psilocybin on the first session and the low dose on the second session

Primary Outcome Measures

Name	Time	Method
GRID-HAM-D-17 -- Structured Interview Guide for the Hamilton Depression Scale.	Baseline, 5 weeks post session 1 and 2, 6-month follow-up	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
HAM-A Assessed With the SIGH-A -- a Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A).	Baseline, 5 weeks post session 1 and 2, 6-month follow-up	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

Trial Locations

Locations (1)

Behavioral Pharmacology Research Unit, Johns Hopkins Bayview Campus; 🇺🇸 Baltimore, Maryland, United States