<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/NCT04466215</url>
  </required_header>
  <id_info>
    <org_study_id>NIAAAMAS006420</org_study_id>
    <secondary_id>U01AA025476</secondary_id>
    <nct_id>NCT04466215</nct_id>
  </id_info>
  <brief_title>Medication Development for Protracted Abstinence in Alcoholism: CORT118335 Versus Placebo</brief_title>
  <official_title>Medication Development for Protracted Abstinence in Alcoholism: CORT118335 Versus Placebo</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Scripps Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Alcohol Abuse and Alcoholism (NIAAA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>The Scripps Research Institute</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 hypotheses under test are that subjects with alcohol use disorder (AUD) of moderate or&#xD;
      greater severity treated with CORT118335 will report decreased craving for alcohol following&#xD;
      alcohol exposure in the laboratory and report significantly less drinking under naturalistic&#xD;
      conditions, than those treated with placebo.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 15, 2021</start_date>
  <completion_date type="Actual">June 7, 2022</completion_date>
  <primary_completion_date type="Actual">April 15, 2022</primary_completion_date>
  <phase>Phase 2</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>
    <intervention_model_description>Parallel Assignment, Double-Blind, Randomized</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Craving to Drink</measure>
    <time_frame>1 hour on the last day of dosing (Day 14)</time_frame>
    <description>Total Visual Analog Scale (VAS) scores of craving severity in response to in vivo alcohol cues. Higher scores indicate greater craving severity with a minimum score of 0 and a maximum score of 80.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Drinking</measure>
    <time_frame>11 days (Treatment effects on drinking were assessed during the 11 days of ad libitum drinking)</time_frame>
    <description>Number of standard drinks per day using the Timeline Followback Interview (TLFB). Total number of alcoholic drinks consumed per day with a minimum value of 0 and an undetermined maximum value.&#xD;
Treatment effects on drinking were assessed during the 11 days of ad libitum drinking and did not include the final three days of mandatory abstinence prior to cue reactivity session.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Alcohol Use Disorder</condition>
  <arm_group>
    <arm_group_label>Miricorilant</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>900 mg (6 x 150 mg) tablets daily taken orally for two weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Six placebo tablets taken orally for two weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Miricorilant</intervention_name>
    <description>900 mg (6 x 150 mg) tablets taken orally once daily for two weeks</description>
    <arm_group_label>Miricorilant</arm_group_label>
    <other_name>CORT118335</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo oral tablet</intervention_name>
    <description>Six placebo tablets taken orally once daily for two weeks</description>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Sugar pill</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female volunteers, 18-75 years of age.&#xD;
&#xD;
          -  Meets DSM-5 criteria for current alcohol use disorder of moderate or greater severity&#xD;
             (AUD-MS).&#xD;
&#xD;
          -  Subjects will not be seeking treatment because the medication studies are not&#xD;
             treatment trials, and to avoid exposing treatment-seekers to alcohol cues.&#xD;
&#xD;
          -  Subjects must be abstinent a minimum of 3 days (but not more than 7 days) prior to the&#xD;
             human lab session.&#xD;
&#xD;
          -  In acceptable health in the judgment of the study physician, based on interview,&#xD;
             medical history, physical exam, ECG, routine urine and blood chemistry.&#xD;
&#xD;
          -  Subjects with a history of depression, who have been on a stable dose of&#xD;
             anti-depressant medication for at least 3 months, and do not meet current DSM-5&#xD;
             criteria for depression or anxiety.&#xD;
&#xD;
          -  All subjects must agree to use double barrier birth control for the study duration and&#xD;
             one month thereafter i.e., males must use condoms and females must use spermicide&#xD;
             and/or a non hormonal barrier method, and their opposite sex partner must likewise use&#xD;
             an effective non hormonal form of contraception.&#xD;
&#xD;
          -  Able to provide informed consent and understand questionnaires and study procedures in&#xD;
             English.&#xD;
&#xD;
          -  Willing to comply with the provisions of the protocol and take daily oral medication&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Medical conditions that could be aggravated by glucocorticoid and/or mineralocorticoid&#xD;
             antagonism.&#xD;
&#xD;
          -  Clinically significant findings on physical exam, ECG, urine or blood tests that may&#xD;
             increase risk.&#xD;
&#xD;
          -  CYP2C19 inhibitors&#xD;
&#xD;
          -  Substrates metabolized primarily by CYP3A, CYP2C9, and CYP2C8 with narrow therapeutic&#xD;
             index&#xD;
&#xD;
          -  BCRP and UGT1A1 substrates&#xD;
&#xD;
          -  Meets DSM-5 criteria for a current major psychiatric disorder, including mood, anxiety&#xD;
             or substance use disorders, other than alcohol, nicotine, or mild cannabis use&#xD;
             disorders.&#xD;
&#xD;
          -  Pregnant or lactating.&#xD;
&#xD;
          -  Treatment within the month prior to screening with (1) an investigational drug, (2)&#xD;
             drugs which may negatively interact with study medications, or (3) drugs that may&#xD;
             influence study outcomes (e.g., disulfiram [Antabuse], naltrexone [ReVia], acamprosate&#xD;
             [Campral], or anticonvulsants.&#xD;
&#xD;
          -  Chronic systemic steroid use&#xD;
&#xD;
          -  Using drugs that are strong inhibitors and inducers of CYP2C9.&#xD;
&#xD;
          -  No fixed domicile and/or no availability by home or mobile telephone.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Barbara J. Mason, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Scripps Research Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Scripps Research Institute Pearson Center for Alcoholism and Addiction Research</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92037</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>July 6, 2020</study_first_submitted>
  <study_first_submitted_qc>July 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 10, 2020</study_first_posted>
  <results_first_submitted>December 29, 2022</results_first_submitted>
  <results_first_submitted_qc>January 31, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">February 3, 2023</results_first_posted>
  <last_update_submitted>January 31, 2023</last_update_submitted>
  <last_update_submitted_qc>January 31, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Alcohol-Related Disorders</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alcoholism</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>October 1, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/15/NCT04466215/Prot_003.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 28, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/15/NCT04466215/SAP_004.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>February 3, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/15/NCT04466215/ICF_005.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Subjects were recruited for study participation at the Laboratory of Clinical Psychopharmacology at The Scripps Research Institute in La Jolla, CA from 04/15/2021-05/25/2022. Seventy-seven non-treatment seeking, paid volunteers signed informed consent, Fifty subjects were enrolled, and Fifty subjects completed the study.</recruitment_details>
      <pre_assignment_details>Twenty-seven subjects were excluded from study participation, twenty-five did not meet admission criteria and two declined to participate.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>CORT118335</title>
          <description>900 mg (6 x 150 mg) tablets daily taken orally for two weeks&#xD;
CORT118335: 900 mg (6 x 150 mg) tablets taken orally once daily for two weeks</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>Six placebo tablets taken orally for two weeks&#xD;
Placebo oral tablet: Six placebo tablets taken orally once daily for two weeks</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
                <participants group_id="P2" count="25"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
                <participants group_id="P2" count="25"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>CORT118335</title>
          <description>900 mg (6 x 150 mg) tablets daily taken orally for two weeks&#xD;
CORT118335: 900 mg (6 x 150 mg) tablets taken orally once daily for two weeks</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>Six placebo tablets taken orally for two weeks&#xD;
Placebo oral tablet: Six placebo tablets taken orally once daily for two weeks</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="25"/>
            <count group_id="B2" value="25"/>
            <count group_id="B3" value="50"/>
          </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="41.04" spread="12.9"/>
                    <measurement group_id="B2" value="43.56" spread="15.0"/>
                    <measurement group_id="B3" value="42.3" spread="28.56"/>
                  </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="15"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="26"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="42"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </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="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="39"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>DSM-V symptom count</title>
          <description>Symptom count from the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-V) criteria for Alcohol Use Disorder (AUD)</description>
          <units>Symptom count</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6.56" spread="1.9"/>
                    <measurement group_id="B2" value="6.56" spread="1.5"/>
                    <measurement group_id="B3" value="6.56" spread="1.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Craving to Drink</title>
        <description>Total Visual Analog Scale (VAS) scores of craving severity in response to in vivo alcohol cues. Higher scores indicate greater craving severity with a minimum score of 0 and a maximum score of 80.</description>
        <time_frame>1 hour on the last day of dosing (Day 14)</time_frame>
        <population>All subjects who completed cue exposure testing in the laboratory were included.</population>
        <group_list>
          <group group_id="O1">
            <title>CORT118335</title>
            <description>900 mg (6 x 150 mg) tablets daily taken orally for two weeks&#xD;
CORT118335: 900 mg (6 x 150 mg) tablets taken orally once daily for two weeks</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Six placebo tablets taken orally for two weeks&#xD;
Placebo oral tablet: Six placebo tablets taken orally once daily for two weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Craving to Drink</title>
          <description>Total Visual Analog Scale (VAS) scores of craving severity in response to in vivo alcohol cues. Higher scores indicate greater craving severity with a minimum score of 0 and a maximum score of 80.</description>
          <population>All subjects who completed cue exposure testing in the laboratory were included.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.1" lower_limit="23.8" upper_limit="38.5"/>
                    <measurement group_id="O2" value="33.2" lower_limit="23.3" upper_limit="43.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Mixed effect model with directional hypothesis that drug reduces strength of craving (VAS). Principle predictor was drug plasma concentration. Arms were combined for this analysis.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.065</p_value>
            <p_value_desc>One-tail test of directional hypothesis.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Slope</param_type>
            <param_value>-0.063</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>.04</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Drinking</title>
        <description>Number of standard drinks per day using the Timeline Followback Interview (TLFB). Total number of alcoholic drinks consumed per day with a minimum value of 0 and an undetermined maximum value.&#xD;
Treatment effects on drinking were assessed during the 11 days of ad libitum drinking and did not include the final three days of mandatory abstinence prior to cue reactivity session.</description>
        <time_frame>11 days (Treatment effects on drinking were assessed during the 11 days of ad libitum drinking)</time_frame>
        <population>All subjects with post baseline drinking data were included.</population>
        <group_list>
          <group group_id="O1">
            <title>CORT118335</title>
            <description>900 mg (6 x 150 mg) tablets daily taken orally for two weeks&#xD;
CORT118335: 900 mg (6 x 150 mg) tablets taken orally once daily for two weeks</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Six placebo tablets taken orally for two weeks&#xD;
Placebo oral tablet: Six placebo tablets taken orally once daily for two weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Drinking</title>
          <description>Number of standard drinks per day using the Timeline Followback Interview (TLFB). Total number of alcoholic drinks consumed per day with a minimum value of 0 and an undetermined maximum value.&#xD;
Treatment effects on drinking were assessed during the 11 days of ad libitum drinking and did not include the final three days of mandatory abstinence prior to cue reactivity session.</description>
          <population>All subjects with post baseline drinking data were included.</population>
          <units>Average drinks per day</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.7" spread=".41"/>
                    <measurement group_id="O2" value="3.7" spread=".29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse event data was collected at all study visits, for an average duration of 4 weeks (2 weeks on drug, and 2 weeks post treatment).</time_frame>
      <desc>Adverse events, both serious and other, were documented at all study visits by the Medical Assistant on the adverse events case report form.</desc>
      <group_list>
        <group group_id="E1">
          <title>CORT118335</title>
          <description>900 mg (6 x 150 mg) tablets daily taken orally for two weeks&#xD;
CORT118335: 900 mg (6 x 150 mg) tablets taken orally once daily for two weeks</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>Six placebo tablets taken orally for two weeks&#xD;
Placebo oral tablet: Six placebo tablets taken orally once daily for two weeks</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="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA</default_vocab>
        <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="9" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Feeling less euphoric</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT 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>Dr. Barbara J.. Mason, Ph.D.</name_or_title>
      <organization>The Scripps Research Institute</organization>
      <phone>(858) 784-7324</phone>
      <email>mason@scripps.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/NCT04466215
org study id: NIAAAMAS006420
secondary id: U01AA025476
nct id: NCT04466215
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The hypotheses under test are that subjects with alcohol use disorder (AUD) of moderate or
      greater severity treated with CORT118335 will report decreased craving for alcohol following
      alcohol exposure in the laboratory and report significantly less drinking under naturalistic
      conditions, than those treated with placebo.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Parallel Assignment, Double-Blind, Randomized
primary purpose: Other
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Craving to Drink
time frame: 1 hour on the last day of dosing (Day 14)
description: Total Visual Analog Scale (VAS) scores of craving severity in response to in vivo alcohol cues. Higher scores indicate greater craving severity with a minimum score of 0 and a maximum score of 80.
measure: Drinking
time frame: 11 days (Treatment effects on drinking were assessed during the 11 days of ad libitum drinking)
description: Number of standard drinks per day using the Timeline Followback Interview (TLFB). Total number of alcoholic drinks consumed per day with a minimum value of 0 and an undetermined maximum value.
Treatment effects on drinking were assessed during the 11 days of ad libitum drinking and did not include the final three days of mandatory abstinence prior to cue reactivity session.
arm group label: Miricorilant
arm group type: Active Comparator
description: 900 mg (6 x 150 mg) tablets daily taken orally for two weeks
arm group label: Placebo
arm group type: Placebo Comparator
description: Six placebo tablets taken orally for two weeks
intervention type: Drug
intervention name: Miricorilant
description: 900 mg (6 x 150 mg) tablets taken orally once daily for two weeks
arm group label: Miricorilant
other name: CORT118335
intervention type: Drug
intervention name: Placebo oral tablet
description: Six placebo tablets taken orally once daily for two weeks
arm group label: Placebo
other name: Sugar pill
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Barbara J. Mason, Ph.D.
role: Principal Investigator
affiliation: The Scripps Research Institute
facility: 
country: United States
responsible party type: Sponsor
mesh term: Alcoholism
sharing ipd: No
provided document: 
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 