Pilot Study: Effects of Psilocybin on Behavior, Psychology and Brain Function in Long-term Meditators
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01988311|
Recruitment Status : Completed
First Posted : November 20, 2013
Last Update Posted : May 20, 2014
This is a pilot study to finalize methods for a larger study being planned for the future. This research is being done to characterize performance of tasks, brain functioning, and the effects of psilocybin in individuals with a long-term meditation practice.
There are three different parts of the pilot study:
- Effects of psilocybin on psychological function: This version of the pilot study will involve 1 or 2 day-long psilocybin sessions, and several meetings and data assessment visits. You will make a total of about 5 to 10 visits to our research unit (the BPRU on the Johns Hopkins Bayview Campus).
- Performance on behavioral and cognitive tasks: This version of the pilot study will involve completing various behavioral and cognitive tasks at our research unit. You will make a total of about 1-10 visits to our research unit (the BPRU on the Johns Hopkins Bayview Campus).
- Brain functioning: This version of the study will involve 1 to 3 brain imaging (MRI) measurements. You will make a total of about 2 to 5 visits to our research unit (the BPRU on the Johns Hopkins Bayview Campus). The MRI measurements will be taken at the F.M. Kirby Research Center at the Kennedy Krieger Institute (across the street from the Johns Hopkins Hospital).
People who are between the ages of 25 and 80 years old, who have a current, regular meditation practice, and who meet the medical requirements may join.
|Condition or disease||Intervention/treatment||Phase|
|Psilocybin Hallucinogens Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Psychotropic Drugs||Drug: psilocybin||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Pilot Study: Effects of Psilocybin on Behavior, Psychology and Brain Function in Long-term Meditators|
|Study Start Date :||May 2013|
|Actual Primary Completion Date :||January 2014|
|Actual Study Completion Date :||May 2014|
Experimental: Drug Only
psilocybin dose manipulation as described in the protocol
dose manipulation as described in the protocol
|No Intervention: Cognitive/Behavioral Tasks Only|
|No Intervention: Imaging Only|
- Persisting Effects Questionnaire [ Time Frame: 8 weeks post session ]Measures changes in spirituality, personal well-being, relationships, and emotions.
- Hood Mysticism Scale [ Time Frame: End of session day ]Measures subjective experience associated with classical mystical experiences.
- States of Consciousness Questionnaire [ Time Frame: End of session day ]Measures subjective experience associated with classical mystical experiences.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01988311
|United States, Maryland|
|Behavioral Pharmacology Research Unit, Johns Hopkins Bayview Medical Center|
|Baltimore, Maryland, United States, 21224|
|Principal Investigator:||Roland R Griffiths, Ph.D.||Johns Hopkins University|