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Effects of Psilocybin-facilitated Experience on the Psychology and Effectiveness of Professional Leaders in Religion

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ClinicalTrials.gov Identifier: NCT02243813
Recruitment Status : Recruiting
First Posted : September 18, 2014
Last Update Posted : October 11, 2018
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:
The current protocol is a pilot study of the effects and possible utility of psilocybin-facilitated experiences for professional religious leaders.

Condition or disease Intervention/treatment Phase
Healthy Drug: Psilocybin Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Study Start Date : March 2015
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2020

Arm Intervention/treatment
Experimental: Delayed Participation
Participants will begin the psilocybin intervention 6 months after study enrollment.
Drug: Psilocybin
Participants will receive 20 mg/70 kg of psilocybin in the first session and will receive either 20 or 30 mg/70 kg in the second session.

Experimental: Immediate Participation
Participants will begin psilocybin intervention immediately after study enrollment.
Drug: Psilocybin
Participants will receive 20 mg/70 kg of psilocybin in the first session and will receive either 20 or 30 mg/70 kg in the second session.




Primary Outcome Measures :
  1. Interim Questionnaire [ Time Frame: 6 months after enrollment ]
    This questionnaire asks about experiences and changes in attitudes, mood and behavior that occurred during the past 5 months. The questionnaire includes questions about salient spiritual experiences, changes in spiritual practices, changes in attitudes, moods, social interactions, and other behaviors related to participants' religious/spiritual vocation.



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  • Have given written informed consent
  • College graduation or equivalent and graduate/professional training.
  • Recognized leadership position in a well-established religious organization; professional activities must include significant time interacting with those seeking religious/spiritual guidance or support.
  • 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
  • During the next year there is no foreseen likelihood for a major potentially life-altering event for her or himself or a close family member (e.g. retirement or major career change for the volunteer; life-threatening illness of a spouse or child of the volunteer)
  • 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 psilocybin 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, 24 hours before and after each drug administration. The exception is caffeine. Participants will be required to be either a non-smoker or a non-daily smoker.
  • Agree not to take any Pro-re-nata (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.

General medical 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 Electrocardiogram (ECG) abnormality (e.g., symptomatic atrial fibrillation), or Transient Ischemic Attack (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 Mono amine Oxidase (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 Diagnostic and Statistics Manual (DSM)-5 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-5 criteria for alcohol or substance use disorder (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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02243813


Contacts
Contact: Mary Cosimano 410-550-5990 mcosima1@jhmi.edu
Contact: John M Clifton 410-550-3074 jclifto6@jhmi.edu

Locations
United States, Maryland
Behavioral Biology Research Center, Johns Hopkins Bayview Recruiting
Baltimore, Maryland, United States, 21224
Contact: Mary Cosimano    410-550-5990      
Contact: John M Clifton    410-550-3074    jclifto6@jhmi.edu   
Principal Investigator: Roland R Griffiths, Ph.D.         
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Roland R Griffiths, Ph.D. JHUSOM

Additional Information:
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02243813     History of Changes
Other Study ID Numbers: IRB00036973
First Posted: September 18, 2014    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018

Keywords provided by Johns Hopkins University:
Psilocybin
Pharmacologic Actions
Psychotropic Drugs

Additional relevant MeSH terms:
Psilocybin
Hallucinogens
Physiological Effects of Drugs
Psychotropic Drugs