Pilot Study: Effects of Psilocybin on Behavior, Psychology and Brain Function in Long-term Meditators

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Roland Griffiths, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01988311
First received: October 18, 2013
Last updated: May 19, 2014
Last verified: May 2014
  Purpose

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:

  1. 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).
  2. 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).
  3. 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 Intervention Phase
Psilocybin
Hallucinogens
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Drug: psilocybin
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Pilot Study: Effects of Psilocybin on Behavior, Psychology and Brain Function in Long-term Meditators

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Persisting Effects Questionnaire [ Time Frame: 8 weeks post session ] [ Designated as safety issue: No ]
    Measures changes in spirituality, personal well-being, relationships, and emotions.

  • Hood Mysticism Scale [ Time Frame: End of session day ] [ Designated as safety issue: No ]
    Measures subjective experience associated with classical mystical experiences.

  • States of Consciousness Questionnaire [ Time Frame: End of session day ] [ Designated as safety issue: No ]
    Measures subjective experience associated with classical mystical experiences.


Estimated Enrollment: 10
Study Start Date: May 2013
Study Completion Date: May 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Drug Only
psilocybin dose manipulation as described in the protocol
Drug: psilocybin
dose manipulation as described in the protocol
No Intervention: Cognitive/Behavioral Tasks Only
No Intervention: Imaging Only

  Eligibility

Ages Eligible for Study:   25 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 25 to 80 years old
  • Have given written informed consent
  • Have some college-level education (college degree preferred)
  • Be healthy and psychologically stable as determined by screening for medical and psychiatric problems via a personal interview, a medical questionnaire, a physical examination, an electrocardiogram (ECG), and routine medical blood and urinalysis laboratory tests
  • Agree to consume approximately the same amount of caffeine-containing beverage (e.g., coffee, tea) that he/she consumes on a usual morning, before arriving at the research unit on the mornings of drug session days. If the participant does not routinely consume caffeinated beverages, he/she must agree not to do so on session days.
  • Agree to refrain from using any psychoactive drugs, including alcoholic beverages and nicotine, within 24 hours of each drug administration. The exception is caffeine. Participants will be required to be non-smokers.
  • Agree not to take any PRN medications on the mornings of drug sessions
  • Agree not to take sildenafil (Viagra®), tadalafil, or similar medications within 72 hours of each drug administration.
  • Agree that for one week before each drug session, he/she will refrain from taking any nonprescription medication, nutritional supplement, or herbal supplement except when approved by the study investigators. Exceptions will be evaluated by the study investigators and will include acetaminophen, non-steroidal anti-inflammatory drugs, and common doses of vitamins and minerals.

Exclusion Criteria:

  • Women who are pregnant (as indicated by a positive urine pregnancy test assessed at intake and before each drug session) or nursing; women who are of child-bearing potential and sexually active who are not practicing an effective means of birth control.
  • Cardiovascular conditions: coronary artery disease, stroke, angina, uncontrolled hypertension, a clinically significant ECG abnormality (e.g., atrial fibrillation), or TIA in the past year
  • Epilepsy with history of seizures
  • Insulin-dependent diabetes; if taking oral hypoglycemic agent, then no history of hypoglycemia
  • Currently taking psychoactive prescription medication on a regular (e.g., daily) basis
  • Currently taking on a regular (e.g., daily) basis any medications having a primary centrally-acting pharmacological effect on serotonin neurons or medications that are MAO inhibitors. For individuals who have intermittent or PRN use of such medications, psilocybin sessions will not be conducted until at least 5 half-lives of the agent have elapsed after the last dose.
  • More than 20% outside the upper or lower range of ideal body weight according to Metropolitan Life height and weight table

Psychiatric Exclusion Criteria:

  • Current or past history of meeting DSM-IV criteria for Schizophrenia, Psychotic Disorder (unless substance-induced or due to a medical condition), or Bipolar I or II Disorder
  • Current or past history within the last 5 years of meeting DSM-IV criteria for alcohol or drug dependence (excluding caffeine and nicotine) or severe major depression
  • Have a first or second-degree relative with Schizophrenia, Psychotic Disorder (unless substance induced or due to a medical condition), or Bipolar I or II Disorder
  • Has a psychiatric condition judged to be incompatible with establishment of rapport or safe exposure to psilocybin

fMRI Exclusion Criteria:

  • Head trauma
  • Claustrophobia
  • Cardiac pacemaker
  • Implanted cardiac defibrillator
  • Aneurysm brain clip
  • Inner ear implant
  • Artificial heart valve (last 6 weeks)
  • Prior history as a metal worker and/or certain metallic objects in the body
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01988311

Locations
United States, Maryland
Behavioral Pharmacology Research Unit, Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Roland R Griffiths, Ph.D. Johns Hopkins University
  More Information

No publications provided

Responsible Party: Roland Griffiths, Professor, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01988311     History of Changes
Other Study ID Numbers: NA_00047665
Study First Received: October 18, 2013
Last Updated: May 19, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Johns Hopkins University:
Psilocybin
Hallucinogens
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

Additional relevant MeSH terms:
Central Nervous System Agents
Psilocybine
Therapeutic Uses
Pharmacologic Actions
Hallucinogens
Physiological Effects of Drugs
Psychotropic Drugs

ClinicalTrials.gov processed this record on August 25, 2014