Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Sidney Kimmel Comprehensive Cancer Center Heffter Research Institute |
---|---|
Information provided by: | Sidney Kimmel Comprehensive Cancer Center |
ClinicalTrials.gov Identifier: | NCT00465595 |
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.
Condition | Intervention |
---|---|
Depressive Symptoms Anxiety Cancer |
Drug: psilocybin |
Study Type: | Interventional |
Study Design: | Supportive Care, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment |
Official Title: | Psychopharmacology of Psilocybin in Cancer Patients |
Estimated Enrollment: | 44 |
Study Start Date: | April 2007 |
Estimated Study Completion Date: | October 2009 |
Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
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 70 years old and who meet the medical requirements may join. About 44 people are expected to take part in this study.
Ages Eligible for Study: | 21 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria
Volunteers must:
Exclusion criteria
General Medical Exclusion Criteria
Hepatic dysfunction as indicated by the following values:
Psychiatric Exclusion Criteria
Cardiovascular screening:
There will be at least four blood pressure assessment occasions over at least two separate days. Within a day, assessment occasions will be separated by at least 15 minutes. Each assessment occasion will involve two or more blood pressure readings. To qualify for the study, the mean blood pressure (mm Hg) of the four or more assessment occasions will not exceed 140 systolic and 90 diastolic.
Blood pressure will be taken while subjects are at rest and have been seated or supine for at least 5 minutes. As recommended by the Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure, these assessments will involve the average of 2 or more readings separated by two minutes. If the first 2 readings differ by more than 5 mm Hg, additional readings will be obtained and averaged. On one or more of the blood pressure measurement occasions, the volunteer will be acclimated to the automated blood pressure monitoring equipment by repeatedly taking blood pressure (at least 3 readings) with the device. Because it has been our experience that time-to-time blood pressure readings with the automated equipment can be variable due to measurement artifact, any reading that initially exceeds our threshold value will be reassessed twice within 4 minutes to assure accuracy.
Contact: Mary Cosimano, MSW | 410-550-5990 | mcosima1@jhmi.edu |
United States, Maryland | |
Behavioral Pharmacology Research Unit, Johns Hopkins Bayview Campus | Recruiting |
Baltimore, Maryland, United States, 21224 | |
Contact: Mary Cosimano 410-550-5990 | |
Principal Investigator: Roland Griffiths, Ph.D. |
Principal Investigator: | Roland R Griffiths, Ph.D. | Johns Hopkins School of Medicine, Psychiatry Dept. |
Responsible Party: | Johns Hopkins School of Medicine, Dept. of Psychiatry ( Roland R. Griffiths, Ph.D. ) |
Study ID Numbers: | J0647, Johns Hopkins IRB5 NA_00001390 |
Study First Received: | April 23, 2007 |
Last Updated: | December 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00465595 |
Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board |
N,N-Dimethyltryptamine Depression Psilocybine |
Depressive Disorder Serotonin Behavioral Symptoms |
Serotonin Agonists Neurotransmitter Agents Serotonin Antagonists Serotonin Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses |
Physiological Effects of Drugs Psychotropic Drugs Hallucinogens Central Nervous System Agents Pharmacologic Actions |