<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02243813</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00036973</org_study_id>
    <nct_id>NCT02243813</nct_id>
  </id_info>
  <brief_title>Effects of Psilocybin-facilitated Experience on the Psychology and Effectiveness of Professional Leaders in Religion</brief_title>
  <official_title>Effects of Psilocybin-facilitated Experience on the Psychology and Effectiveness of Professional Leaders in Religion</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Johns Hopkins University</source>
  <brief_summary>
    <textblock>
      The current protocol is a pilot study of the effects and possible utility of&#xD;
      psilocybin-facilitated experiences for professional religious leaders.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date>March 2015</start_date>
  <completion_date type="Anticipated">May 2024</completion_date>
  <primary_completion_date type="Anticipated">May 2024</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Interim Questionnaire</measure>
    <time_frame>6 months after enrollment</time_frame>
    <description>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.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Delayed Participation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will begin the psilocybin intervention 6 months after study enrollment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Immediate Participation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will begin psilocybin intervention immediately after study enrollment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Psilocybin</intervention_name>
    <description>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.</description>
    <arm_group_label>Delayed Participation</arm_group_label>
    <arm_group_label>Immediate Participation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Have given written informed consent&#xD;
&#xD;
          -  College graduation or equivalent and graduate/professional training.&#xD;
&#xD;
          -  Recognized leadership position in a well-established religious organization;&#xD;
             professional activities must include significant time interacting with those seeking&#xD;
             religious/spiritual guidance or support.&#xD;
&#xD;
          -  Be healthy and psychologically stable as determined by screening for medical and&#xD;
             psychiatric problems via a personal interview, a medical questionnaire, a physical&#xD;
             examination, an electrocardiogram (ECG), and routine medical blood and urinalysis&#xD;
             laboratory tests&#xD;
&#xD;
          -  During the next year there is no foreseen likelihood for a major potentially&#xD;
             life-altering event for her or himself or a close family member (e.g. retirement or&#xD;
             major career change for the volunteer; life-threatening illness of a spouse or child&#xD;
             of the volunteer)&#xD;
&#xD;
          -  Agree to consume approximately the same amount of caffeine-containing beverage (e.g.,&#xD;
             coffee, tea) that he/she consumes on a usual morning, before arriving at the research&#xD;
             unit on the mornings of psilocybin session days. If the participant does not routinely&#xD;
             consume caffeinated beverages, he/she must agree not to do so on session days.&#xD;
&#xD;
          -  Agree to refrain from using any psychoactive drugs, including alcoholic beverages and&#xD;
             nicotine, 24 hours before and after each drug administration. The exception is&#xD;
             caffeine. Participants will be required to be either a non-smoker or a non-daily&#xD;
             smoker.&#xD;
&#xD;
          -  Agree not to take any Pro-re-nata (PRN) medications on the mornings of drug sessions&#xD;
&#xD;
          -  Agree not to take sildenafil (Viagra®), tadalafil, or similar medications within 72&#xD;
             hours of each drug administration.&#xD;
&#xD;
          -  Agree that for one week before each drug session, he/she will refrain from taking any&#xD;
             nonprescription medication, nutritional supplement, or herbal supplement except when&#xD;
             approved by the study investigators. Exceptions will be evaluated by the study&#xD;
             investigators and will include acetaminophen, non-steroidal anti-inflammatory drugs,&#xD;
             and common doses of vitamins and minerals.&#xD;
&#xD;
        General medical exclusion criteria:&#xD;
&#xD;
          -  Women who are pregnant (as indicated by a positive urine pregnancy test assessed at&#xD;
             intake and before each drug session) or nursing; women who are of child-bearing&#xD;
             potential and sexually active who are not practicing an effective means of birth&#xD;
             control.&#xD;
&#xD;
          -  Cardiovascular conditions: coronary artery disease, stroke, angina, uncontrolled&#xD;
             hypertension, a clinically significant Electrocardiogram (ECG) abnormality (e.g.,&#xD;
             symptomatic atrial fibrillation), or Transient Ischemic Attack (TIA) in the past year&#xD;
&#xD;
          -  Epilepsy with history of seizures&#xD;
&#xD;
          -  Insulin-dependent diabetes; if taking oral hypoglycemic agent, then no history of&#xD;
             hypoglycemia&#xD;
&#xD;
          -  Currently taking psychoactive prescription medication on a regular (e.g., daily) basis&#xD;
&#xD;
          -  Currently taking on a regular (e.g., daily) basis any medications having a primary&#xD;
             centrally-acting pharmacological effect on serotonin neurons or medications that are&#xD;
             Mono amine Oxidase (MAO) inhibitors. For individuals who have intermittent or PRN use&#xD;
             of such medications, psilocybin sessions will not be conducted until at least 5&#xD;
             half-lives of the agent have elapsed after the last dose.&#xD;
&#xD;
          -  More than 20% outside the upper or lower range of ideal body weight according to&#xD;
             Metropolitan Life height and weight table&#xD;
&#xD;
        Psychiatric Exclusion Criteria:&#xD;
&#xD;
          -  Current or past history of meeting Diagnostic and Statistics Manual (DSM)-5 criteria&#xD;
             for Schizophrenia, Psychotic Disorder (unless substance-induced or due to a medical&#xD;
             condition), or Bipolar I or II Disorder&#xD;
&#xD;
          -  Current or past history within the last 5 years of meeting DSM-5 criteria for alcohol&#xD;
             or substance use disorder (excluding caffeine and nicotine) or severe major depression&#xD;
&#xD;
          -  Have a first or second-degree relative with Schizophrenia, Psychotic Disorder (unless&#xD;
             substance induced or due to a medical condition), or Bipolar I or II Disorder&#xD;
&#xD;
          -  Has a psychiatric condition judged to be incompatible with establishment of rapport or&#xD;
             safe exposure to psilocybin&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Roland R Griffiths, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>JHUSOM</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Behavioral Biology Research Center, Johns Hopkins Bayview</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.religiousleaderstudy.org</url>
    <description>Study Flyer</description>
  </link>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>September 16, 2014</study_first_submitted>
  <study_first_submitted_qc>September 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 18, 2014</study_first_posted>
  <last_update_submitted>May 10, 2023</last_update_submitted>
  <last_update_submitted_qc>May 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 11, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Psilocybin</keyword>
  <keyword>Pharmacologic Actions</keyword>
  <keyword>Psychotropic Drugs</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Psilocybin</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02243813
org study id: IRB00036973
nct id: NCT02243813
lead sponsor: 
The current protocol is a pilot study of the effects and possible utility of
      psilocybin-facilitated experiences for professional religious leaders.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Interim Questionnaire
time frame: 6 months after enrollment
description: 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.
arm group label: Delayed Participation
arm group type: Experimental
description: Participants will begin the psilocybin intervention 6 months after study enrollment.
arm group label: Immediate Participation
arm group type: Experimental
description: Participants will begin psilocybin intervention immediately after study enrollment.
intervention type: Drug
intervention name: Psilocybin
description: 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.
arm group label: Delayed Participation
arm group label: Immediate Participation
criteria: 
gender: All
minimum age: 25 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Roland R Griffiths, Ph.D.
role: Principal Investigator
affiliation: JHUSOM
facility: 
country: United States
url: http://www.religiousleaderstudy.org
description: Study Flyer
responsible party type: Sponsor
mesh term: Psilocybin