<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/NCT02243709</url>
  </required_header>
  <id_info>
    <org_study_id>1404001031</org_study_id>
    <nct_id>NCT02243709</nct_id>
  </id_info>
  <brief_title>Mifepristone for the Prevention of Relapses of Alcohol Drinking</brief_title>
  <official_title>A Pilot Study on the Safety and Efficacy of Mifepristone for the Prevention of Relapses of Alcohol Drinking</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Brown University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Brown University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this study is to determine if, under stress, alcohol drinking is reduced using&#xD;
      mifepristone&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2014</start_date>
  <completion_date type="Actual">December 21, 2021</completion_date>
  <primary_completion_date type="Actual">December 21, 2021</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>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants Experiencing Adverse Events in the Mifepristone Versus Placebo Group as a Measure of Safety and Tolerability</measure>
    <time_frame>5 weeks (one week of drug administration, 3 weeks of washout, followed by one week of drug administration)</time_frame>
    <description>Safety and tolerability was assessed by the number of participants who experienced adverse events (AEs) while taking the medication, in the mifepristone group verses the placebo group during Visit 2 through and until Visit 5. AEs were assessed at each visit and special attention was paid to any AEs experienced after administration of the oral administration of mifepristone or placebo- Visit 2 to Visit 3 (7 days total) and Visit 4 through Visit 5 (7 days total), and when it was administered with alcohol during the laboratory paradigms at visits 3 and 4.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Alcohol Craving Score on the Alcohol Craving Questionnaire in the Mifepristone Versus Placebo Group</measure>
    <time_frame>1 day</time_frame>
    <description>Alcohol craving will be assessed by the Alcohol Craving Questionnaire Short Form - Revised (ACQ-SF-R). The ACQ-SF-R is a 12-item self-report scale that contains items from the 47-item Alcohol Craving Questionnaire (ACQ-Now). ACQ-SF-R also produces scores for compulsivity, expectancy, purposefulness, and emotionality. To assess this outcome, at the alcohol cue reactivity procedures/visits 3 and 5 during alcohol trial 1, the 12-item total ACQ will be summed for each participant and then the total score will be averaged for a mean score. The average ACQ score in the presence of alcohol cues will be compared when participants are taking mifepristone compared to placebo. The ACQ has a total score range between 0-84. A lower score indicates less subjective alcohol craving.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Drinking Consumption in the Mifepristone Verses Placebo Group</measure>
    <time_frame>1 day</time_frame>
    <description>Number of standard drinks desired to be consumed by participants during mifepristone administration compared to placebo administration during the open bar (free choice procedure) in the alcohol cue reactivity at visits 3 and 5.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Alcohol Use Disorders (AUD)</condition>
  <arm_group>
    <arm_group_label>Mifepristone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>mifepristone 600-mg/day for a week, in a stress-induced condition triggered by a single dose of 32.4-mg of yohimbine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sugar pill</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>matching placebo/day for a week, in a stress-induced condition triggered by a single dose of 32.4-mg of yohimbine</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Mifepristone 600-mg/day or placebo for a week</intervention_name>
    <description>600-mg of mifepristone for a week, compared to placebo for a week, in a stress-induced condition triggered by a single dose of 32.4 mg of yohimbine</description>
    <arm_group_label>Mifepristone</arm_group_label>
    <arm_group_label>Sugar pill</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female, 21 to 65 years of age&#xD;
&#xD;
          -  Females must be postmenopausal for at least one year or surgically sterile (proven by&#xD;
             medical record)&#xD;
&#xD;
          -  Meet criteria for Alcohol Use Disorders (AUD) DSM-5 diagnosis&#xD;
&#xD;
          -  Meet drinking criteria (≥3 drinks/day for men; ≥2 drinks /day for women)&#xD;
&#xD;
          -  Must be in good health as confirmed by medical history, physical examination, ECG, lab&#xD;
             tests&#xD;
&#xD;
          -  Participants must be willing to take oral medication and adhere to the study&#xD;
             procedures&#xD;
&#xD;
          -  Breath alcohol (BrAC) = 0.00 at each visit&#xD;
&#xD;
          -  Be able to understand informed consent and questionnaire in English at an 8th grade&#xD;
             level&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Individuals expressing interest in treatment for alcoholism&#xD;
&#xD;
          -  Premenopausal women&#xD;
&#xD;
          -  Participants who have significant alcohol withdrawal symptoms, defined as a CIWA-Ar&#xD;
             score ≥7&#xD;
&#xD;
          -  A repeated positive urine drug screen at baseline for any illegal substance except&#xD;
             marijuana.&#xD;
&#xD;
          -  Individuals diagnosed with a current &quot;severe&quot; Substance Use Disorder (SUD) diagnosis,&#xD;
             other than alcohol or nicotine&#xD;
&#xD;
          -  Meet DSM-5 criteria for a diagnosis of schizophrenia, bipolar disorder, or other&#xD;
             psychoses&#xD;
&#xD;
          -  An active illness within the past six months of the screening visit that meets the&#xD;
             DSM-5 criteria for a diagnosis of Major Depressive Disorder (MDD) or Anxiety Disorder,&#xD;
             or history of attempted suicide&#xD;
&#xD;
          -  Clinically significant medical abnormalities: unstable hypertension, clinically&#xD;
             significant abnormal ECG, bilirubin &gt;150% of the upper normal limit, ALT/AST &gt;300% the&#xD;
             UNL, creatinine clearance ≤60 dl/min&#xD;
&#xD;
          -  Current use of psychotropic medications that may have an effect on alcohol consumption&#xD;
&#xD;
          -  Current use of any medication involved in the metabolism of alcohol such as aldehyde&#xD;
             dehydrogenase (ALDH), alcohol dehydrogenase (ADH) and CYP2E1: Cefamandole, Cefotetan,&#xD;
             Sulfamethoxazole, Nitroglycerin, Chlorpropamide, Glyburide.&#xD;
&#xD;
          -  Current use of any medication (CYP3A4 inhibitor and substrate) that may interact with&#xD;
             mifepristone: cyclosporine, fentanyl, heparin, escitalopram, lovastatin, simvastatin,&#xD;
             warfarin&#xD;
&#xD;
          -  Current use of any medication (CYP2D6 inhibitor and substrate) that may interact with&#xD;
             yohimbine: amitriptyline, doxepin, nortriptyline, venlafaxine&#xD;
&#xD;
          -  Medical contraindications for use of mifepristone or yohimbine&#xD;
&#xD;
          -  A history of adverse reaction or hypersensitivity to mifepristone or yohimbine&#xD;
&#xD;
          -  History of suicide&#xD;
&#xD;
          -  History of seizure disorders&#xD;
&#xD;
          -  Hypokalemia (low potassium level)&lt;3.5mEq/L&#xD;
&#xD;
          -  Participated in any behavioral and/or pharmacological study within minimum the past 30&#xD;
             days&#xD;
&#xD;
          -  Neuroendocrine disorders&#xD;
&#xD;
          -  Taking corticosteroids&#xD;
&#xD;
          -  Bleeding disorders&#xD;
&#xD;
          -  Pre-existing QT prolongation on ECG&#xD;
&#xD;
          -  History of porphyria (Mifepristone progesterone receptor antagonist is an inducer of&#xD;
             CYP-450 and therefore may have the ability to precipitate or exacerbate attacks of&#xD;
             acute porphyria)&#xD;
&#xD;
          -  Not willing to engage in protected sex (condom). This risk includes both women and&#xD;
             men. Mifepristone long half-life (t1/2 = 18 hrs) and its three main metabolites retain&#xD;
             considerable affinity toward human progesterone and glucocorticoid receptors, with&#xD;
             serum level similar to the parent mifepristone and there are no studies on the&#xD;
             presence of mifepristone or metabolites in semen&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Carolina L Haass-Koffler, PharmD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Brown University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Center for Alcohol and Addiction Studies, Brown University</name>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02912</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Simms JA, Haass-Koffler CL, Bito-Onon J, Li R, Bartlett SE. Mifepristone in the central nucleus of the amygdala reduces yohimbine stress-induced reinstatement of ethanol-seeking. Neuropsychopharmacology. 2012 Mar;37(4):906-18. doi: 10.1038/npp.2011.268. Epub 2011 Nov 2.</citation>
    <PMID>22048462</PMID>
  </reference>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>September 12, 2014</study_first_submitted>
  <study_first_submitted_qc>September 17, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 18, 2014</study_first_posted>
  <results_first_submitted>January 18, 2023</results_first_submitted>
  <results_first_submitted_qc>May 4, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">June 1, 2023</results_first_posted>
  <last_update_submitted>May 4, 2023</last_update_submitted>
  <last_update_submitted_qc>May 4, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Brown University</investigator_affiliation>
    <investigator_full_name>Carolina Haass-Koffler</investigator_full_name>
    <investigator_title>Research Fellow</investigator_title>
  </responsible_party>
  <keyword>Stress, alcohol craving, alcohol use disorders</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alcoholism</mesh_term>
    <mesh_term>Alcohol Drinking</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mifepristone</mesh_term>
  </intervention_browse>
  <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>December 15, 2014</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/09/NCT02243709/Prot_000.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>December 15, 2014</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/09/NCT02243709/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Mifepristone, Then Placebo</title>
          <description>Participants receive mifepristone 600-mg/day for one week. Participants then go through a 3 week wash out period where no medications are dispensed. Participants then receive a matched placebo (matching Mifepristone) for one week.</description>
        </group>
        <group group_id="P2">
          <title>Placebo, Then Mifepristone</title>
          <description>Participants receive a placebo pill for one week. Participants then go through a 3 week wash out period where no medications are dispensed. Participants then receive a matched Mifepristone (600 mg/day) dose for one week.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Phase 1</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="17"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Phase 2: Crossover to Opposite Condition</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="17"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="17"/>
              </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>Overall Sample</title>
          <description>All participants receive either Mifepristone (600 mg) or matched placebo that is randomized within a cross-over, double blind clinical trial.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="32"/>
          </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="42.9" spread="11.8"/>
                  </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="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>WHITE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Multiracial</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Alcohol craving</title>
          <description>Alcohol craving will be assessed by the Alcohol Craving Questionnaire Short Form - Revised (ACQ-SF-R). The ACQ-SF-R is a 12-item self-report scale that contains items from the 47-item Alcohol Craving Questionnaire (ACQ-Now). ACQ-SF-R also produces scores for compulsivity, expectancy, purposefulness, and emotionality. In this study, at baseline/the first study visit, the 12-item total ACQ will be summed for each participant and then the total score will be averaged for a mean score. The ACQ has a total score range between 0-84. A lower score indicates less subjective alcohol craving.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="40.9" spread="14.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Experiencing Adverse Events in the Mifepristone Versus Placebo Group as a Measure of Safety and Tolerability</title>
        <description>Safety and tolerability was assessed by the number of participants who experienced adverse events (AEs) while taking the medication, in the mifepristone group verses the placebo group during Visit 2 through and until Visit 5. AEs were assessed at each visit and special attention was paid to any AEs experienced after administration of the oral administration of mifepristone or placebo- Visit 2 to Visit 3 (7 days total) and Visit 4 through Visit 5 (7 days total), and when it was administered with alcohol during the laboratory paradigms at visits 3 and 4.</description>
        <time_frame>5 weeks (one week of drug administration, 3 weeks of washout, followed by one week of drug administration)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Mifepristone</title>
            <description>mifepristone 600-mg/day for a week, after a single dose of 32.4-mg of yohimbine</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>matching placebo/day for a week, after a single dose of 32.4-mg of yohimbine</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Experiencing Adverse Events in the Mifepristone Versus Placebo Group as a Measure of Safety and Tolerability</title>
          <description>Safety and tolerability was assessed by the number of participants who experienced adverse events (AEs) while taking the medication, in the mifepristone group verses the placebo group during Visit 2 through and until Visit 5. AEs were assessed at each visit and special attention was paid to any AEs experienced after administration of the oral administration of mifepristone or placebo- Visit 2 to Visit 3 (7 days total) and Visit 4 through Visit 5 (7 days total), and when it was administered with alcohol during the laboratory paradigms at visits 3 and 4.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="3"/>
                  </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>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&gt;.05</p_value>
            <method>Chi-squared</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Alcohol Craving Score on the Alcohol Craving Questionnaire in the Mifepristone Versus Placebo Group</title>
        <description>Alcohol craving will be assessed by the Alcohol Craving Questionnaire Short Form - Revised (ACQ-SF-R). The ACQ-SF-R is a 12-item self-report scale that contains items from the 47-item Alcohol Craving Questionnaire (ACQ-Now). ACQ-SF-R also produces scores for compulsivity, expectancy, purposefulness, and emotionality. To assess this outcome, at the alcohol cue reactivity procedures/visits 3 and 5 during alcohol trial 1, the 12-item total ACQ will be summed for each participant and then the total score will be averaged for a mean score. The average ACQ score in the presence of alcohol cues will be compared when participants are taking mifepristone compared to placebo. The ACQ has a total score range between 0-84. A lower score indicates less subjective alcohol craving.</description>
        <time_frame>1 day</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Mifepristone</title>
            <description>Mifepristone 600-mg/day for one week.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Administration of matched placebo for one week.</description>
          </group>
        </group_list>
        <measure>
          <title>Alcohol Craving Score on the Alcohol Craving Questionnaire in the Mifepristone Versus Placebo Group</title>
          <description>Alcohol craving will be assessed by the Alcohol Craving Questionnaire Short Form - Revised (ACQ-SF-R). The ACQ-SF-R is a 12-item self-report scale that contains items from the 47-item Alcohol Craving Questionnaire (ACQ-Now). ACQ-SF-R also produces scores for compulsivity, expectancy, purposefulness, and emotionality. To assess this outcome, at the alcohol cue reactivity procedures/visits 3 and 5 during alcohol trial 1, the 12-item total ACQ will be summed for each participant and then the total score will be averaged for a mean score. The average ACQ score in the presence of alcohol cues will be compared when participants are taking mifepristone compared to placebo. The ACQ has a total score range between 0-84. A lower score indicates less subjective alcohol craving.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.92" spread="17.85"/>
                    <measurement group_id="O2" value="50.13" spread="19.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Drinking Consumption in the Mifepristone Verses Placebo Group</title>
        <description>Number of standard drinks desired to be consumed by participants during mifepristone administration compared to placebo administration during the open bar (free choice procedure) in the alcohol cue reactivity at visits 3 and 5.</description>
        <time_frame>1 day</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Mifepristone</title>
            <description>Administration of mifepristone 600-mg/day for one week.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Administration of matched placebo for one week.</description>
          </group>
        </group_list>
        <measure>
          <title>Drinking Consumption in the Mifepristone Verses Placebo Group</title>
          <description>Number of standard drinks desired to be consumed by participants during mifepristone administration compared to placebo administration during the open bar (free choice procedure) in the alcohol cue reactivity at visits 3 and 5.</description>
          <units>drinks</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8" spread="0.3"/>
                    <measurement group_id="O2" value="0.5" spread="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>AEs were monitored for 5 weeks (one week of medication administration, followed by a three week wash out period, then followed by another week of medication administration). Medication administration is randomized between subjects within a cross over design.</time_frame>
      <desc>Participant were screened initially with a full physical assessment</desc>
      <group_list>
        <group group_id="E1">
          <title>Mifepristone</title>
          <description>mifepristone 600-mg/day for a week, after a single dose of 32.4-mg of yohimbine</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>matching placebo/day for a week, after a single dose of 32.4-mg of yohimbine</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="27"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="31"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>3</frequency_threshold>
        <default_assessment>Non-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="0" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="31"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>hypertension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="31"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>emesis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="31"/>
              </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>Prof. Carolina Haass-Koffler</name_or_title>
      <organization>Brown University</organization>
      <phone>4155191385</phone>
      <email>carolina_haass-koffler@brown.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/NCT02243709
org study id: 1404001031
nct id: NCT02243709
lead sponsor: 
has dmc: No
The goal of this study is to determine if, under stress, alcohol drinking is reduced using
      mifepristone
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Number of Participants Experiencing Adverse Events in the Mifepristone Versus Placebo Group as a Measure of Safety and Tolerability
time frame: 5 weeks (one week of drug administration, 3 weeks of washout, followed by one week of drug administration)
description: Safety and tolerability was assessed by the number of participants who experienced adverse events (AEs) while taking the medication, in the mifepristone group verses the placebo group during Visit 2 through and until Visit 5. AEs were assessed at each visit and special attention was paid to any AEs experienced after administration of the oral administration of mifepristone or placebo- Visit 2 to Visit 3 (7 days total) and Visit 4 through Visit 5 (7 days total), and when it was administered with alcohol during the laboratory paradigms at visits 3 and 4.
measure: Alcohol Craving Score on the Alcohol Craving Questionnaire in the Mifepristone Versus Placebo Group
time frame: 1 day
description: Alcohol craving will be assessed by the Alcohol Craving Questionnaire Short Form - Revised (ACQ-SF-R). The ACQ-SF-R is a 12-item self-report scale that contains items from the 47-item Alcohol Craving Questionnaire (ACQ-Now). ACQ-SF-R also produces scores for compulsivity, expectancy, purposefulness, and emotionality. To assess this outcome, at the alcohol cue reactivity procedures/visits 3 and 5 during alcohol trial 1, the 12-item total ACQ will be summed for each participant and then the total score will be averaged for a mean score. The average ACQ score in the presence of alcohol cues will be compared when participants are taking mifepristone compared to placebo. The ACQ has a total score range between 0-84. A lower score indicates less subjective alcohol craving.
measure: Drinking Consumption in the Mifepristone Verses Placebo Group
time frame: 1 day
description: Number of standard drinks desired to be consumed by participants during mifepristone administration compared to placebo administration during the open bar (free choice procedure) in the alcohol cue reactivity at visits 3 and 5.
arm group label: Mifepristone
arm group type: Active Comparator
description: mifepristone 600-mg/day for a week, in a stress-induced condition triggered by a single dose of 32.4-mg of yohimbine
arm group label: Sugar pill
arm group type: Placebo Comparator
description: matching placebo/day for a week, in a stress-induced condition triggered by a single dose of 32.4-mg of yohimbine
intervention type: Drug
intervention name: Mifepristone 600-mg/day or placebo for a week
description: 600-mg of mifepristone for a week, compared to placebo for a week, in a stress-induced condition triggered by a single dose of 32.4 mg of yohimbine
arm group label: Mifepristone
arm group label: Sugar pill
criteria: 
gender: All
minimum age: 21 Years
maximum age: 65 Years
healthy volunteers: No
last name: Carolina L Haass-Koffler, PharmD
role: Principal Investigator
affiliation: Brown University
facility: 
country: United States
citation: Simms JA, Haass-Koffler CL, Bito-Onon J, Li R, Bartlett SE. Mifepristone in the central nucleus of the amygdala reduces yohimbine stress-induced reinstatement of ethanol-seeking. Neuropsychopharmacology. 2012 Mar;37(4):906-18. doi: 10.1038/npp.2011.268. Epub 2011 Nov 2.
PMID: 22048462
responsible party type: Principal Investigator
investigator affiliation: Brown University
investigator full name: Carolina Haass-Koffler
investigator title: Research Fellow
mesh term: Alcoholism
mesh term: Alcohol Drinking
mesh term: Mifepristone
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 