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

• ClinicalTrials.gov Identifier: NCT02243813
• Recruitment Status: Active, not recruiting
• First Posted: September 18, 2014
• Last Update Posted: May 11, 2023
• Sponsor: Johns Hopkins University
• Information provided by (Responsible Party): Johns Hopkins University

Tracking Information

• First Submitted Date: September 16, 2014
• First Posted Date: September 18, 2014
• Last Update Posted Date: May 11, 2023
• Study Start Date: March 2015
• Estimated Primary Completion Date: May 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 16, 2014)

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.

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effects of Psilocybin-facilitated Experience on the Psychology and Effectiveness of Professional Leaders in Religion
• Official Title: Effects of Psilocybin-facilitated Experience on the Psychology and Effectiveness of Professional Leaders in Religion
• Brief Summary: The current protocol is a pilot study of the effects and possible utility of psilocybin-facilitated experiences for professional religious leaders.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Basic Science
• Condition: Healthy

Intervention

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.

Study Arms

• Experimental: Delayed Participation
  Participants will begin the psilocybin intervention 6 months after study enrollment.
  Intervention: Drug: Psilocybin
• Experimental: Immediate Participation
  Participants will begin psilocybin intervention immediately after study enrollment.
  Intervention: Drug: Psilocybin

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: August 3, 2021): 20
• Original Estimated Enrollment (submitted: September 16, 2014): 12
• Estimated Study Completion Date: May 2024
• Estimated Primary Completion Date: May 2024 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 25 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02243813
• Other Study ID Numbers: IRB00036973
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Johns Hopkins University
• Original Responsible Party: Roland Griffiths, Johns Hopkins University, Professor
• Current Study Sponsor: Johns Hopkins University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Roland R Griffiths, Ph.D.; JHUSOM

• PRS Account: Johns Hopkins University
• Verification Date: May 2023