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
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Tracking Information | ||||
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First Submitted Date ICMJE | April 23, 2007 | |||
First Posted Date ICMJE | April 25, 2007 | |||
Results First Submitted Date ICMJE | January 26, 2017 | |||
Results First Posted Date ICMJE | July 19, 2018 | |||
Last Update Posted Date | July 19, 2018 | |||
Study Start Date ICMJE | April 2007 | |||
Actual Primary Completion Date | December 2014 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
Psychological response to psilocybin as assessed by validated questionnaires. | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE | Not Provided | |||
Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Psychopharmacology of Psilocybin in Cancer Patients | |||
Official Title ICMJE | Psychopharmacology of Psilocybin in Cancer Patients | |||
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. |
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Supportive Care |
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Condition ICMJE |
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Intervention ICMJE | Drug: psilocybin
The dose of psilocybin received in the two sessions will range anywhere from low to high.
Other Name: O-phosphoryl-4-hydroxy-N,N-dimethyltryptamine
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Study Arms ICMJE |
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Publications * | 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. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
56 | |||
Original Enrollment ICMJE |
44 | |||
Actual Study Completion Date ICMJE | December 2016 | |||
Actual Primary Completion Date | December 2014 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion criteria Volunteers must:
Exclusion criteria General Medical Exclusion Criteria
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. |
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Sex/Gender ICMJE |
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Ages ICMJE | 21 Years to 80 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00465595 | |||
Other Study ID Numbers ICMJE | NA_00001390 Johns Hopkins IRB5 NA_00001390 |
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Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | Johns Hopkins University | |||
Original Responsible Party | Not Provided | |||
Current Study Sponsor ICMJE | Johns Hopkins University | |||
Original Study Sponsor ICMJE | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |||
Collaborators ICMJE | Heffter Research Institute | |||
Investigators ICMJE |
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PRS Account | Johns Hopkins University | |||
Verification Date | June 2018 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |