<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/NCT02971605</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00102081</org_study_id>
    <secondary_id>R03DA042336</secondary_id>
    <nct_id>NCT02971605</nct_id>
  </id_info>
  <brief_title>Persisting Effects of Psilocybin</brief_title>
  <official_title>Measurement of Persisting Changes in Emotional Brain Functioning Produced by Psilocybin</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Drug Abuse (NIDA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Johns Hopkins University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The proposed pilot study will assess whether ingestion of a classic hallucinogen (psilocybin)&#xD;
      leads to changes in emotion processing and neural circuitry that may predict repeated&#xD;
      self-administration of this drug and underlie an atypical mechanism of abuse liability, which&#xD;
      may vitally contribute to the understanding of the potential for abuse and the underlying&#xD;
      mechanisms supporting abuse of classic hallucinogens.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2017</start_date>
  <completion_date type="Actual">August 21, 2018</completion_date>
  <primary_completion_date type="Actual">August 21, 2018</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Amygdala Response to Stimuli in the Emotion Recognition Test</measure>
    <time_frame>1 day pre (baseline), 1 week post, and 1 month post session</time_frame>
    <description>Blood oxygenation level-dependent (BOLD) percent signal change in response to stimuli in the emotion recognition task was measured in the left and right amygdala.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Longitudinal Emotion and Mood Questionnaire Scores</measure>
    <time_frame>1 day pre (baseline), 1 week post, and 1 month post session</time_frame>
    <description>Participants were assessed on a variety of questionnaires that probed emotional functioning and mood state. Higher scores on each subscale are indicative of higher levels of each emotion/mood (e.g., low score on Depression (POMS) indicates low level of depressed mood).&#xD;
Depression Anxiety Stress Scale (DASS): Range 0-56 on all subscales&#xD;
Dispositional Positive Emotion Scale (DPES): Range 1-7 on all subscales&#xD;
Positive &amp; Negative Affect Schedule Expanded (PANAS-X): Range 0-50 on all subscales&#xD;
Profile of Mood States (POMS): Ranges vary by subscale. Tension (0-36); Depression (0-60); Anger (0-48); Fatigue (0-28); Confusion (0-28); Vigor (0-36); Mood Disturbance (-36-168)&#xD;
State Trait Anxiety Inventory (STAI): Range 20-80 on all subscales&#xD;
Tellegen Absorption Scale (TAS): Range 0-34&#xD;
Big Five Inventory (BFI): Range 1-5 on all subscales</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Emotional Functioning Task Accuracy</measure>
    <time_frame>1 day pre (baseline), 1 week post, and 1 month post session</time_frame>
    <description>These tasks measure emotional responding that may be altered by psilocybin.&#xD;
Emotional discrimination task: participants were presented with images of emotional facial expressions or shapes (control), and were instructed to discriminate between the images.&#xD;
Emotion recognition task: participants were presented images of actors and were asked to identify the emotional facial expression (happy, sad, fear, angry, neutral) of each actor.&#xD;
Emotional conflict Stroop task: participants were shown emotional facial expressions (targets) with emotional words overlain (distractors) and were asked to identify the valence of the facial expression, either positive or negative.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Emotional Functioning Tasks Response Time (Milliseconds)</measure>
    <time_frame>1-day pre (baseline), 1-week post, 1-month post session</time_frame>
    <description>These tasks measure emotional responding that may be altered by psilocybin.&#xD;
Emotional discrimination task: participants were presented with images of emotional facial expressions or shapes (control), and were instructed to discriminate between the images.&#xD;
Emotion recognition task: participants were presented images of actors and were asked to identify the emotional facial expression (happy, sad, fear, angry, neutral) of each actor.&#xD;
Emotional conflict Stroop task: participants were shown emotional facial expressions (targets) with emotional words overlain (distractors) and were asked to identify the valence of the facial expression, either positive or negative.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">13</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Psilocybin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be administered a 25 mg/70 kg dose of psilocybin</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Psilocybin</intervention_name>
    <description>25 mg/70 kg Psilocybin</description>
    <arm_group_label>Psilocybin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Have given written informed consent&#xD;
&#xD;
          -  Have at least a high-school level of education or equivalent, and be fluent in English&#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;
          -  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 morning of the drug session day. If the participant does not routinely&#xD;
             consume caffeinated beverages, he/she must agree not to do so on the session day.&#xD;
&#xD;
          -  Agree to refrain from using any psychoactive drugs, including alcoholic beverages and&#xD;
             nicotine, within 24 hours of each drug administration. The exception is caffeine.&#xD;
&#xD;
          -  Agree not to take any &quot;as needed&quot; 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;
          -  Have limited lifetime use of hallucinogens&#xD;
&#xD;
        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 ECG abnormality (e.g., atrial fibrilation),&#xD;
             artificial heart valve, or stroke 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 serotonergic effect, including mono-amine oxidase inhibitors (MAOIs).&#xD;
             For individuals who have intermittent or &quot;as needed&quot; use of such medications,&#xD;
             psilocybin sessions will not be conducted until at least 5 half-lives of the agent&#xD;
             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;
          -  Current or past history of meeting Diagnostic and Statistical Manual of Mental&#xD;
             Disorders, 5th edition (DSM-5) criteria for schizophrenia spectrum or other psychotic&#xD;
             disorders (except substance/medication-induced or due to another medical condition),&#xD;
             or Bipolar I or II Disorder&#xD;
&#xD;
          -  Current or past history within the last 5 years of meeting DSM-5 criteria for a&#xD;
             moderate or severe alcohol or drug use disorder (excluding caffeine and nicotine)&#xD;
&#xD;
          -  Have a first or second-degree relative with schizophrenia spectrum or other psychotic&#xD;
             disorders (except substance/medication-induced or due to another medical condition),&#xD;
             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;
&#xD;
          -  Head trauma&#xD;
&#xD;
          -  Claustrophobia incompatible with scanning&#xD;
&#xD;
          -  Cardiac pacemaker&#xD;
&#xD;
          -  Implanted cardiac defibrillator&#xD;
&#xD;
          -  Aneurysm brain clip&#xD;
&#xD;
          -  Inner ear implant&#xD;
&#xD;
          -  Prior history as a metal worker and/or certain metallic objects in the body -- must&#xD;
             complete magnetic resonance imaging (MRI) screening form and be approved by MRI&#xD;
             technologist before each scan&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Frederick S Barrett, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Behavioral Pharmacology Research Unit, Johns Hopkins Bayview Medical Center</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>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>November 21, 2016</study_first_submitted>
  <study_first_submitted_qc>November 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 23, 2016</study_first_posted>
  <results_first_submitted>July 31, 2019</results_first_submitted>
  <results_first_submitted_qc>August 21, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">September 10, 2019</results_first_posted>
  <last_update_submitted>August 21, 2019</last_update_submitted>
  <last_update_submitted_qc>August 21, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 10, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Psilocybin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Anonymized data will be shared with qualified scientists upon request.</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>April 24, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/05/NCT02971605/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Psilocybin</title>
          <description>Participants will be administered a 25 mg/70 kg dose of psilocybin&#xD;
Psilocybin: 25 mg/70 kg Psilocybin</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Psilocybin</title>
          <description>Participants will be administered a 25 mg/70 kg dose of psilocybin&#xD;
Psilocybin: 25 mg/70 kg Psilocybin</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="13"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="32.2" spread="7.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Education Level</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>High School/GED</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>College</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Post-Graduate</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Amygdala Response to Stimuli in the Emotion Recognition Test</title>
        <description>Blood oxygenation level-dependent (BOLD) percent signal change in response to stimuli in the emotion recognition task was measured in the left and right amygdala.</description>
        <time_frame>1 day pre (baseline), 1 week post, and 1 month post session</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Baseline</title>
            <description>One day prior to psilocybin administration.</description>
          </group>
          <group group_id="O2">
            <title>1-week Post Session</title>
            <description>One week post psilocybin (25 mg/70 kg) administration.</description>
          </group>
          <group group_id="O3">
            <title>1-month Post Session</title>
            <description>One month post psilocybin (25 mg/70 kg) administration.</description>
          </group>
        </group_list>
        <measure>
          <title>Amygdala Response to Stimuli in the Emotion Recognition Test</title>
          <description>Blood oxygenation level-dependent (BOLD) percent signal change in response to stimuli in the emotion recognition task was measured in the left and right amygdala.</description>
          <units>BOLD percent signal change</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>L Amygdala contrast: Happy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.835" spread="0.342"/>
                    <measurement group_id="O2" value="-0.759" spread="0.63"/>
                    <measurement group_id="O3" value="0.619" spread="0.449"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>L Amygdala contrast: Sad</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.503" spread="0.403"/>
                    <measurement group_id="O2" value="-0.514" spread="0.635"/>
                    <measurement group_id="O3" value="0.999" spread="0.563"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>L Amygdala contrast: Fearful</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.525" spread="0.421"/>
                    <measurement group_id="O2" value="-0.928" spread="0.696"/>
                    <measurement group_id="O3" value="0.664" spread="0.584"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>L Amygdala contrast: Angry</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.514" spread="0.357"/>
                    <measurement group_id="O2" value="-0.881" spread="0.703"/>
                    <measurement group_id="O3" value="1.131" spread="0.569"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>L Amygdala contrast: Neutral</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.794" spread="0.437"/>
                    <measurement group_id="O2" value="-0.825" spread="0.572"/>
                    <measurement group_id="O3" value="1.098" spread="0.582"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>R Amygdala contrast: Happy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.938" spread="0.388"/>
                    <measurement group_id="O2" value="-0.052" spread="0.431"/>
                    <measurement group_id="O3" value="0.749" spread="0.478"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>R Amygdala contrast: Sad</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.927" spread="0.423"/>
                    <measurement group_id="O2" value="0.004" spread="0.37"/>
                    <measurement group_id="O3" value="0.816" spread="0.444"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>R Amygdala contrast: Fearful</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.979" spread="0.424"/>
                    <measurement group_id="O2" value="-0.254" spread="0.481"/>
                    <measurement group_id="O3" value="0.617" spread="0.563"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>R Amygdala contrast: Angry</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.834" spread="0.449"/>
                    <measurement group_id="O2" value="-0.028" spread="0.39"/>
                    <measurement group_id="O3" value="0.689" spread="0.454"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>R Amygdala contrast: Neutral</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.081" spread="0.428"/>
                    <measurement group_id="O2" value="-0.256" spread="0.358"/>
                    <measurement group_id="O3" value="0.719" spread="0.476"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Longitudinal Emotion and Mood Questionnaire Scores</title>
        <description>Participants were assessed on a variety of questionnaires that probed emotional functioning and mood state. Higher scores on each subscale are indicative of higher levels of each emotion/mood (e.g., low score on Depression (POMS) indicates low level of depressed mood).&#xD;
Depression Anxiety Stress Scale (DASS): Range 0-56 on all subscales&#xD;
Dispositional Positive Emotion Scale (DPES): Range 1-7 on all subscales&#xD;
Positive &amp; Negative Affect Schedule Expanded (PANAS-X): Range 0-50 on all subscales&#xD;
Profile of Mood States (POMS): Ranges vary by subscale. Tension (0-36); Depression (0-60); Anger (0-48); Fatigue (0-28); Confusion (0-28); Vigor (0-36); Mood Disturbance (-36-168)&#xD;
State Trait Anxiety Inventory (STAI): Range 20-80 on all subscales&#xD;
Tellegen Absorption Scale (TAS): Range 0-34&#xD;
Big Five Inventory (BFI): Range 1-5 on all subscales</description>
        <time_frame>1 day pre (baseline), 1 week post, and 1 month post session</time_frame>
        <population>The Big Five Inventory (BFI) and the Tellegen Absorption Scale (TAS) were not administered at 1-week post, and were only administered at Baseline and 1-month post.</population>
        <group_list>
          <group group_id="O1">
            <title>Baseline</title>
            <description>One day prior to psilocybin administration.</description>
          </group>
          <group group_id="O2">
            <title>1-week Post Session</title>
            <description>One week post psilocybin (25 mg/70 kg) administration.</description>
          </group>
          <group group_id="O3">
            <title>1-month Post Session</title>
            <description>One month post psilocybin (25 mg/70 kg) administration.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Longitudinal Emotion and Mood Questionnaire Scores</title>
          <description>Participants were assessed on a variety of questionnaires that probed emotional functioning and mood state. Higher scores on each subscale are indicative of higher levels of each emotion/mood (e.g., low score on Depression (POMS) indicates low level of depressed mood).&#xD;
Depression Anxiety Stress Scale (DASS): Range 0-56 on all subscales&#xD;
Dispositional Positive Emotion Scale (DPES): Range 1-7 on all subscales&#xD;
Positive &amp; Negative Affect Schedule Expanded (PANAS-X): Range 0-50 on all subscales&#xD;
Profile of Mood States (POMS): Ranges vary by subscale. Tension (0-36); Depression (0-60); Anger (0-48); Fatigue (0-28); Confusion (0-28); Vigor (0-36); Mood Disturbance (-36-168)&#xD;
State Trait Anxiety Inventory (STAI): Range 20-80 on all subscales&#xD;
Tellegen Absorption Scale (TAS): Range 0-34&#xD;
Big Five Inventory (BFI): Range 1-5 on all subscales</description>
          <population>The Big Five Inventory (BFI) and the Tellegen Absorption Scale (TAS) were not administered at 1-week post, and were only administered at Baseline and 1-month post.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Depression (DASS)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.82" spread="0.57"/>
                    <measurement group_id="O2" value="1.09" spread="0.73"/>
                    <measurement group_id="O3" value="1.64" spread="0.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Anxiety (DASS)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.64" spread="1.07"/>
                    <measurement group_id="O2" value="1.64" spread="0.75"/>
                    <measurement group_id="O3" value="1.45" spread="0.90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Stress (DASS)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.91" spread="1.06"/>
                    <measurement group_id="O2" value="2.00" spread="0.60"/>
                    <measurement group_id="O3" value="3.27" spread="1.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Joy (DPES)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.45" spread="0.21"/>
                    <measurement group_id="O2" value="6.02" spread="0.17"/>
                    <measurement group_id="O3" value="5.92" spread="0.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Content (DPES)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.62" spread="0.24"/>
                    <measurement group_id="O2" value="6.27" spread="0.16"/>
                    <measurement group_id="O3" value="6.13" spread="0.23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pride (DPES)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.42" spread="0.22"/>
                    <measurement group_id="O2" value="5.96" spread="0.14"/>
                    <measurement group_id="O3" value="5.95" spread="0.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Love (DPES)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.61" spread="0.17"/>
                    <measurement group_id="O2" value="5.92" spread="0.25"/>
                    <measurement group_id="O3" value="5.98" spread="0.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Compassion (DPES)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.75" spread="0.31"/>
                    <measurement group_id="O2" value="6.25" spread="0.26"/>
                    <measurement group_id="O3" value="6.00" spread="0.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Amusement (DPES)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.02" spread="0.31"/>
                    <measurement group_id="O2" value="5.60" spread="0.32"/>
                    <measurement group_id="O3" value="5.71" spread="0.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Awe (DPES)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.52" spread="0.26"/>
                    <measurement group_id="O2" value="6.06" spread="0.22"/>
                    <measurement group_id="O3" value="5.88" spread="0.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Positive Affect (PANAS-X)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.18" spread="1.41"/>
                    <measurement group_id="O2" value="40.64" spread="1.28"/>
                    <measurement group_id="O3" value="40.18" spread="1.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Negative Affect (PANAS-X)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.09" spread="1.00"/>
                    <measurement group_id="O2" value="12.36" spread="0.93"/>
                    <measurement group_id="O3" value="16.09" spread="0.80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Tension (POMS)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.82" spread="1.22"/>
                    <measurement group_id="O2" value="1.73" spread="0.49"/>
                    <measurement group_id="O3" value="3.82" spread="1.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Depression (POMS)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.36" spread="0.81"/>
                    <measurement group_id="O2" value="0.55" spread="0.25"/>
                    <measurement group_id="O3" value="2.64" spread="1.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Anger (POMS)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.91" spread="1.34"/>
                    <measurement group_id="O2" value="2.18" spread="0.58"/>
                    <measurement group_id="O3" value="4.64" spread="0.98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fatigue (POMS)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.09" spread="1.37"/>
                    <measurement group_id="O2" value="2.27" spread="1.21"/>
                    <measurement group_id="O3" value="2.72" spread="1.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Confusion (POMS)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.55" spread="1.19"/>
                    <measurement group_id="O2" value="4.27" spread="0.79"/>
                    <measurement group_id="O3" value="4.72" spread="1.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vigor (POMS)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.09" spread="1.35"/>
                    <measurement group_id="O2" value="21.45" spread="1.77"/>
                    <measurement group_id="O3" value="22.09" spread="2.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mood Disturbance (POMS)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.64" spread="5.67"/>
                    <measurement group_id="O2" value="-10.5" spread="3.23"/>
                    <measurement group_id="O3" value="-3.55" spread="6.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>State Anxiety (STAI)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.0" spread="2.41"/>
                    <measurement group_id="O2" value="22.82" spread="1.37"/>
                    <measurement group_id="O3" value="25.64" spread="2.56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Trait Anxiety (STAI)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.36" spread="1.91"/>
                    <measurement group_id="O2" value="28.55" spread="1.32"/>
                    <measurement group_id="O3" value="25.64" spread="27.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Extraversion (BFI)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.46" spread="0.190"/>
                    <measurement group_id="O3" value="3.69" spread="0.183"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Agreeableness (BFI)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.43" spread="0.099"/>
                    <measurement group_id="O3" value="4.33" spread="0.117"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Conscientiousness (BFI)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.82" spread="0.172"/>
                    <measurement group_id="O3" value="3.98" spread="0.159"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neuroticism (BFI)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.82" spread="0.213"/>
                    <measurement group_id="O3" value="1.67" spread="0.175"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Openness (BFI)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.17" spread="0.129"/>
                    <measurement group_id="O3" value="4.22" spread="0.151"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Absorption (TAS)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.98" spread="0.176"/>
                    <measurement group_id="O3" value="1.31" spread="0.233"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Emotional Functioning Task Accuracy</title>
        <description>These tasks measure emotional responding that may be altered by psilocybin.&#xD;
Emotional discrimination task: participants were presented with images of emotional facial expressions or shapes (control), and were instructed to discriminate between the images.&#xD;
Emotion recognition task: participants were presented images of actors and were asked to identify the emotional facial expression (happy, sad, fear, angry, neutral) of each actor.&#xD;
Emotional conflict Stroop task: participants were shown emotional facial expressions (targets) with emotional words overlain (distractors) and were asked to identify the valence of the facial expression, either positive or negative.</description>
        <time_frame>1 day pre (baseline), 1 week post, and 1 month post session</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Baseline</title>
            <description>One day prior to psilocybin administration.</description>
          </group>
          <group group_id="O2">
            <title>1-week Post Session</title>
            <description>One week post psilocybin (25 mg/70 kg) administration.</description>
          </group>
          <group group_id="O3">
            <title>1-month Post Session</title>
            <description>One month post psilocybin (25 mg/70 kg) administration.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Emotional Functioning Task Accuracy</title>
          <description>These tasks measure emotional responding that may be altered by psilocybin.&#xD;
Emotional discrimination task: participants were presented with images of emotional facial expressions or shapes (control), and were instructed to discriminate between the images.&#xD;
Emotion recognition task: participants were presented images of actors and were asked to identify the emotional facial expression (happy, sad, fear, angry, neutral) of each actor.&#xD;
Emotional conflict Stroop task: participants were shown emotional facial expressions (targets) with emotional words overlain (distractors) and were asked to identify the valence of the facial expression, either positive or negative.</description>
          <units>percentage of correct responses</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Emotion recognition task: Happy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92.6" spread="2.7"/>
                    <measurement group_id="O2" value="95.8" spread="2.1"/>
                    <measurement group_id="O3" value="97.9" spread="1.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emotion recognition task: Sad</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="95.7" spread="2.1"/>
                    <measurement group_id="O2" value="93.8" spread="2.5"/>
                    <measurement group_id="O3" value="94.8" spread="2.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emotion recognition task: Fearful</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.0" spread="0.0"/>
                    <measurement group_id="O2" value="99.0" spread="1.0"/>
                    <measurement group_id="O3" value="97.9" spread="1.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emotion recognition task: Angry</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.9" spread="1.5"/>
                    <measurement group_id="O2" value="95.8" spread="2.1"/>
                    <measurement group_id="O3" value="99.0" spread="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emotion recognition task: Neutral</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="93.8" spread="2.5"/>
                    <measurement group_id="O2" value="96.9" spread="1.8"/>
                    <measurement group_id="O3" value="100.0" spread="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emotion discrimination: Shapes (Control)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.0" spread="1.0"/>
                    <measurement group_id="O2" value="97.0" spread="1.0"/>
                    <measurement group_id="O3" value="95.0" spread="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emotion discrimination: Faces</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="87.1" spread="2.4"/>
                    <measurement group_id="O2" value="92.3" spread="1.8"/>
                    <measurement group_id="O3" value="93.2" spread="1.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emotional conflict Stroop: Congruent</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.5" spread="0.3"/>
                    <measurement group_id="O2" value="99.8" spread="0.2"/>
                    <measurement group_id="O3" value="99.5" spread="0.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emotional conflict Stroop: Incongruent</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.1" spread="0.7"/>
                    <measurement group_id="O2" value="97.9" spread="0.7"/>
                    <measurement group_id="O3" value="98.4" spread="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Emotional Functioning Tasks Response Time (Milliseconds)</title>
        <description>These tasks measure emotional responding that may be altered by psilocybin.&#xD;
Emotional discrimination task: participants were presented with images of emotional facial expressions or shapes (control), and were instructed to discriminate between the images.&#xD;
Emotion recognition task: participants were presented images of actors and were asked to identify the emotional facial expression (happy, sad, fear, angry, neutral) of each actor.&#xD;
Emotional conflict Stroop task: participants were shown emotional facial expressions (targets) with emotional words overlain (distractors) and were asked to identify the valence of the facial expression, either positive or negative.</description>
        <time_frame>1-day pre (baseline), 1-week post, 1-month post session</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Baseline</title>
            <description>One day prior to psilocybin administration.</description>
          </group>
          <group group_id="O2">
            <title>1-week Post Session</title>
            <description>One week post psilocybin (25 mg/70 kg) administration.</description>
          </group>
          <group group_id="O3">
            <title>1-month Post Session</title>
            <description>One month post psilocybin (25 mg/70 kg) administration.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Emotional Functioning Tasks Response Time (Milliseconds)</title>
          <description>These tasks measure emotional responding that may be altered by psilocybin.&#xD;
Emotional discrimination task: participants were presented with images of emotional facial expressions or shapes (control), and were instructed to discriminate between the images.&#xD;
Emotion recognition task: participants were presented images of actors and were asked to identify the emotional facial expression (happy, sad, fear, angry, neutral) of each actor.&#xD;
Emotional conflict Stroop task: participants were shown emotional facial expressions (targets) with emotional words overlain (distractors) and were asked to identify the valence of the facial expression, either positive or negative.</description>
          <units>milliseconds</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Emotion recognition task: Happy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1670" spread="59.5"/>
                    <measurement group_id="O2" value="1383" spread="41.2"/>
                    <measurement group_id="O3" value="1454" spread="45.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emotion recognition task: Sad</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1539" spread="53.0"/>
                    <measurement group_id="O2" value="1458" spread="45.6"/>
                    <measurement group_id="O3" value="1596" spread="56.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emotion recognition task: Fearful</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1061" spread="27.2"/>
                    <measurement group_id="O2" value="1045" spread="31.8"/>
                    <measurement group_id="O3" value="1130" spread="40.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emotion recognition task: Angry</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1380" spread="45.9"/>
                    <measurement group_id="O2" value="1193" spread="36.4"/>
                    <measurement group_id="O3" value="1310" spread="40.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emotion recognition task: Neutral</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1305" spread="49.1"/>
                    <measurement group_id="O2" value="1594" spread="49.2"/>
                    <measurement group_id="O3" value="1017" spread="33.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emotion discrimination task: Shapes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="977.0" spread="212.9"/>
                    <measurement group_id="O2" value="1697" spread="414.1"/>
                    <measurement group_id="O3" value="1735" spread="434.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emotion discrimination task: Faces</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1803" spread="51.1"/>
                    <measurement group_id="O2" value="1572" spread="41.1"/>
                    <measurement group_id="O3" value="1522" spread="35.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emotional conflict Stroop: Congruent</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="613.5" spread="6.32"/>
                    <measurement group_id="O2" value="606.3" spread="5.88"/>
                    <measurement group_id="O3" value="603.2" spread="7.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emotional conflict Stroop: Incongruent</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="641.3" spread="7.14"/>
                    <measurement group_id="O2" value="631.4" spread="7.03"/>
                    <measurement group_id="O3" value="614.1" spread="6.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were assessed from Screening to 1-month post psilocybin session (32-70 days).</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Psilocybin</title>
          <description>Participants will be administered a 25 mg/70 kg dose of psilocybin&#xD;
Psilocybin: 25 mg/70 kg Psilocybin</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cardiac event</sub_title>
                <description>Systolic blood pressure higher than 170 mmHg at session timepoint Diastolic blood pressure higher than 100 mmHg at session timepoint. Heart rate higher than 110 beats per minute (BPM) at session timepoint.</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Thyroid hormone changes</sub_title>
                <description>Change in thyroid-stimulating hormone (TSH) and T4 thyroid hormone levels</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Frederick Barrett, Ph.D., Principal Investigator</name_or_title>
      <organization>Johns Hopkins University School of Medicine</organization>
      <phone>4105509777</phone>
      <email>fbarret2@jhmi.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02971605
org study id: IRB00102081
secondary id: R03DA042336
nct id: NCT02971605
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The proposed pilot study will assess whether ingestion of a classic hallucinogen (psilocybin)
      leads to changes in emotion processing and neural circuitry that may predict repeated
      self-administration of this drug and underlie an atypical mechanism of abuse liability, which
      may vitally contribute to the understanding of the potential for abuse and the underlying
      mechanisms supporting abuse of classic hallucinogens.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Amygdala Response to Stimuli in the Emotion Recognition Test
time frame: 1 day pre (baseline), 1 week post, and 1 month post session
description: Blood oxygenation level-dependent (BOLD) percent signal change in response to stimuli in the emotion recognition task was measured in the left and right amygdala.
measure: Change in Longitudinal Emotion and Mood Questionnaire Scores
time frame: 1 day pre (baseline), 1 week post, and 1 month post session
description: Participants were assessed on a variety of questionnaires that probed emotional functioning and mood state. Higher scores on each subscale are indicative of higher levels of each emotion/mood (e.g., low score on Depression (POMS) indicates low level of depressed mood).
Depression Anxiety Stress Scale (DASS): Range 0-56 on all subscales
Dispositional Positive Emotion Scale (DPES): Range 1-7 on all subscales
Positive & Negative Affect Schedule Expanded (PANAS-X): Range 0-50 on all subscales
Profile of Mood States (POMS): Ranges vary by subscale. Tension (0-36); Depression (0-60); Anger (0-48); Fatigue (0-28); Confusion (0-28); Vigor (0-36); Mood Disturbance (-36-168)
State Trait Anxiety Inventory (STAI): Range 20-80 on all subscales
Tellegen Absorption Scale (TAS): Range 0-34
Big Five Inventory (BFI): Range 1-5 on all subscales
measure: Change in Emotional Functioning Task Accuracy
time frame: 1 day pre (baseline), 1 week post, and 1 month post session
description: These tasks measure emotional responding that may be altered by psilocybin.
Emotional discrimination task: participants were presented with images of emotional facial expressions or shapes (control), and were instructed to discriminate between the images.
Emotion recognition task: participants were presented images of actors and were asked to identify the emotional facial expression (happy, sad, fear, angry, neutral) of each actor.
Emotional conflict Stroop task: participants were shown emotional facial expressions (targets) with emotional words overlain (distractors) and were asked to identify the valence of the facial expression, either positive or negative.
measure: Change in Emotional Functioning Tasks Response Time (Milliseconds)
time frame: 1-day pre (baseline), 1-week post, 1-month post session
description: These tasks measure emotional responding that may be altered by psilocybin.
Emotional discrimination task: participants were presented with images of emotional facial expressions or shapes (control), and were instructed to discriminate between the images.
Emotion recognition task: participants were presented images of actors and were asked to identify the emotional facial expression (happy, sad, fear, angry, neutral) of each actor.
Emotional conflict Stroop task: participants were shown emotional facial expressions (targets) with emotional words overlain (distractors) and were asked to identify the valence of the facial expression, either positive or negative.
arm group label: Psilocybin
arm group type: Experimental
description: Participants will be administered a 25 mg/70 kg dose of psilocybin
intervention type: Drug
intervention name: Psilocybin
description: 25 mg/70 kg Psilocybin
arm group label: Psilocybin
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Frederick S Barrett, PhD
role: Principal Investigator
affiliation: Johns Hopkins University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Psilocybin
sharing ipd: Yes
ipd description: Anonymized data will be shared with qualified scientists upon request.
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 