<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/NCT02210195</url>
  </required_header>
  <id_info>
    <org_study_id>DA030988-04S1</org_study_id>
    <secondary_id>R01DA030988-04S1</secondary_id>
    <nct_id>NCT02210195</nct_id>
  </id_info>
  <brief_title>Pharmacological Treatment of Comorbid Alcohol and Marijuana Withdrawal and Dependence</brief_title>
  <official_title>Pharmacological Treatment of Comorbid Alcohol and Marijuana Withdrawal and Dependence</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Scripps Research Institute</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>The Scripps Research Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary aim of the supplemental study is to provide POC testing of aprepitant as a&#xD;
      treatment for comorbid alcohol and cannabis dependence. The data analysis plan specified in&#xD;
      the parent grant will likewise be applied to the supplemental project to test for effects of&#xD;
      aprepitant vs placebo on measures of alcohol and cannabis use and protracted withdrawal. The&#xD;
      primary hypothesis is that subjects treated with aprepitant will have significantly less&#xD;
      alcohol and marijuana use than subjects treated with placebo.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Consistent with the scope and methods of the parent grant, this was a randomized,&#xD;
      double-blind, placebo-controlled, parallel groups, Phase II, single-site, 8-week clinical&#xD;
      trial of aprepitant 125 mg/d or placebo. Participants were 20 outpatients seeking treatment&#xD;
      for concurrent alcohol and cannabis dependence. All participants received weekly&#xD;
      protocol-specific counseling. Research assessments occurred weekly through the treatment&#xD;
      phase of the 8-week study. Post treatment follow-up assessments occurred at Weeks 9 and 12.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 4, 2014</start_date>
  <completion_date type="Actual">December 19, 2016</completion_date>
  <primary_completion_date type="Actual">December 19, 2016</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Week 0 in Cannabis Use Using Urinary CN-THCCOOH Levels at Week 8</measure>
    <time_frame>Week 0 and Week 8</time_frame>
    <description>Urinary THC/Cr ratio, also known as CN-THCCOOH (creatinine normalized tetrahydrocannabinol carboxylic acid), is a highly sensitive and specific quantitative analytic procedure to determine current marijuana metabolite levels in the urine as well as new marijuana use or abstinence. Gas chromatography mass spectrometric levels of 11-nor-9-carboxy-9-THC (THC-COOH), the primary marijuana metabolite, are normalized to the urine creatinine (CN) concentration to reduce the variability of drug measurement attributable to urine dilution. Negative values indicate decreased use. Change = (Week 8 value - Week 0 value).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Week 0 in Drinking Quantity and Frequency Using Drinks Per Week at Week 8</measure>
    <time_frame>Week 0 and Week 8</time_frame>
    <description>Standard drinks are equivalent to 14 grams of pure alcohol and number of drinks are assessed with Timeline Follow-Back (TLFB) methods. Change = (Week 8 - Week 0). More negative values indicate less use of alcohol.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Cannabis Dependence</condition>
  <condition>Alcohol Dependence</condition>
  <condition>Cannabis Use Disorder</condition>
  <condition>Alcohol Use Disorder</condition>
  <arm_group>
    <arm_group_label>Experimental: aprepitant 125 mg/day</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>125 mg aprepitant daily for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo 125mg/d</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Matched placebo pill given daily for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>aprepitant</intervention_name>
    <description>125 mg daily for 8 weeks.</description>
    <arm_group_label>Experimental: aprepitant 125 mg/day</arm_group_label>
    <other_name>Emend</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo daily for 8 weeks.</description>
    <arm_group_label>Placebo 125mg/d</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Manual-guided behavioral counseling</intervention_name>
    <description>Standardized manual-guided behavioral counseling performed 1 time per week for 8 weeks in conjunction with study drug or placebo.</description>
    <arm_group_label>Experimental: aprepitant 125 mg/day</arm_group_label>
    <arm_group_label>Placebo 125mg/d</arm_group_label>
    <other_name>Manual-guided therapy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Males or females from 18-70 years of age&#xD;
&#xD;
          -  Meets DSM IV criteria for current alcohol and cannabis dependence&#xD;
&#xD;
          -  Seeking research-based outpatient treatment for alcohol and cannabis dependence that&#xD;
             involves daily oral medication&#xD;
&#xD;
          -  Negative BAC and a CIWA score &lt; 9 at randomization&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Significant medical disorders or use of medications that will increase potential risk&#xD;
             or influence study outcomes&#xD;
&#xD;
          -  Females who are pregnant, nursing or who are sexually active with child-bearing&#xD;
             potential and refuse to use an effective, non hormonal method of birth control during&#xD;
             the study and for up to 4 weeks after study termination• Treatment with an&#xD;
             investigational drug during the previous month&#xD;
&#xD;
          -  Prior treatment with NK1 antagonists&#xD;
&#xD;
          -  Participants for whom treatment is being mandated by a legal authority• Inability to&#xD;
             understand and/or comply with the provisions of the protocol and consent form&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 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</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>July 2017</verification_date>
  <study_first_submitted>July 31, 2014</study_first_submitted>
  <study_first_submitted_qc>August 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 6, 2014</study_first_posted>
  <results_first_submitted>July 5, 2017</results_first_submitted>
  <results_first_submitted_qc>July 5, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">August 2, 2017</results_first_posted>
  <last_update_submitted>July 5, 2017</last_update_submitted>
  <last_update_submitted_qc>July 5, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 2, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Scripps Research Institute</investigator_affiliation>
    <investigator_full_name>Barbara J. Mason</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Cannabis Treatment</keyword>
  <keyword>Alcohol Treatment</keyword>
  <keyword>Alcohol-Related Disorders</keyword>
  <keyword>Cannabis-Related Disorders</keyword>
  <keyword>Substance-Related Disorders</keyword>
  <keyword>Emend</keyword>
  <keyword>NK1 receptor antagonist</keyword>
  <keyword>Alcohol</keyword>
  <keyword>Cannabis</keyword>
  <keyword>aprepitant</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Marijuana Abuse</mesh_term>
    <mesh_term>Alcoholism</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aprepitant</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Aprepitant: 125mg/Day</title>
          <description>125mg/d aprepitant for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.</description>
        </group>
        <group group_id="P2">
          <title>Matched Placebo</title>
          <description>Matched Placebo daily for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Aprepitant: 125mg/Day</title>
          <description>125mg/d aprepitant for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.</description>
        </group>
        <group group_id="B2">
          <title>Matched Placebo</title>
          <description>Matched Placebo daily for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.</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="10"/>
            <count group_id="B2" value="10"/>
            <count group_id="B3" value="20"/>
          </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="34.5" spread="13.5"/>
                    <measurement group_id="B2" value="35.5" spread="9.3"/>
                    <measurement group_id="B3" value="35.0" spread="11.3"/>
                  </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="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Week 0 in Cannabis Use Using Urinary CN-THCCOOH Levels at Week 8</title>
        <description>Urinary THC/Cr ratio, also known as CN-THCCOOH (creatinine normalized tetrahydrocannabinol carboxylic acid), is a highly sensitive and specific quantitative analytic procedure to determine current marijuana metabolite levels in the urine as well as new marijuana use or abstinence. Gas chromatography mass spectrometric levels of 11-nor-9-carboxy-9-THC (THC-COOH), the primary marijuana metabolite, are normalized to the urine creatinine (CN) concentration to reduce the variability of drug measurement attributable to urine dilution. Negative values indicate decreased use. Change = (Week 8 value - Week 0 value).</description>
        <time_frame>Week 0 and Week 8</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Aprepitant: 125mg/Day</title>
            <description>125mg/d aprepitant for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.</description>
          </group>
          <group group_id="O2">
            <title>Matched Placebo</title>
            <description>Matched Placebo daily for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Week 0 in Cannabis Use Using Urinary CN-THCCOOH Levels at Week 8</title>
          <description>Urinary THC/Cr ratio, also known as CN-THCCOOH (creatinine normalized tetrahydrocannabinol carboxylic acid), is a highly sensitive and specific quantitative analytic procedure to determine current marijuana metabolite levels in the urine as well as new marijuana use or abstinence. Gas chromatography mass spectrometric levels of 11-nor-9-carboxy-9-THC (THC-COOH), the primary marijuana metabolite, are normalized to the urine creatinine (CN) concentration to reduce the variability of drug measurement attributable to urine dilution. Negative values indicate decreased use. Change = (Week 8 value - Week 0 value).</description>
          <units>ng/mg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="198.3" spread="389.4"/>
                    <measurement group_id="O2" value="55.9" spread="239.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Week 0 in Drinking Quantity and Frequency Using Drinks Per Week at Week 8</title>
        <description>Standard drinks are equivalent to 14 grams of pure alcohol and number of drinks are assessed with Timeline Follow-Back (TLFB) methods. Change = (Week 8 - Week 0). More negative values indicate less use of alcohol.</description>
        <time_frame>Week 0 and Week 8</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Aprepitant: 125mg/Day</title>
            <description>125mg/d aprepitant for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.</description>
          </group>
          <group group_id="O2">
            <title>Matched Placebo</title>
            <description>Matched Placebo daily for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Week 0 in Drinking Quantity and Frequency Using Drinks Per Week at Week 8</title>
          <description>Standard drinks are equivalent to 14 grams of pure alcohol and number of drinks are assessed with Timeline Follow-Back (TLFB) methods. Change = (Week 8 - Week 0). More negative values indicate less use of alcohol.</description>
          <units>drinks/week</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-21.0" spread="16.1"/>
                    <measurement group_id="O2" value="-10.7" spread="17.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Aprepitant: 125mg/Day</title>
          <description>125mg/d aprepitant for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.</description>
        </group>
        <group group_id="E2">
          <title>Matched Placebo</title>
          <description>Matched Placebo daily for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (19.0)</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="6" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Faeces discoloured</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Frequent bowel movements</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Toothache</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Foreign body in eye</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Pain in jaw</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
              </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 Mason</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/NCT02210195
org study id: DA030988-04S1
secondary id: R01DA030988-04S1
nct id: NCT02210195
lead sponsor: 
collaborator: 
has dmc: No
The primary aim of the supplemental study is to provide POC testing of aprepitant as a
      treatment for comorbid alcohol and cannabis dependence. The data analysis plan specified in
      the parent grant will likewise be applied to the supplemental project to test for effects of
      aprepitant vs placebo on measures of alcohol and cannabis use and protracted withdrawal. The
      primary hypothesis is that subjects treated with aprepitant will have significantly less
      alcohol and marijuana use than subjects treated with placebo.
Consistent with the scope and methods of the parent grant, this was a randomized,
      double-blind, placebo-controlled, parallel groups, Phase II, single-site, 8-week clinical
      trial of aprepitant 125 mg/d or placebo. Participants were 20 outpatients seeking treatment
      for concurrent alcohol and cannabis dependence. All participants received weekly
      protocol-specific counseling. Research assessments occurred weekly through the treatment
      phase of the 8-week study. Post treatment follow-up assessments occurred at Weeks 9 and 12.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change From Week 0 in Cannabis Use Using Urinary CN-THCCOOH Levels at Week 8
time frame: Week 0 and Week 8
description: Urinary THC/Cr ratio, also known as CN-THCCOOH (creatinine normalized tetrahydrocannabinol carboxylic acid), is a highly sensitive and specific quantitative analytic procedure to determine current marijuana metabolite levels in the urine as well as new marijuana use or abstinence. Gas chromatography mass spectrometric levels of 11-nor-9-carboxy-9-THC (THC-COOH), the primary marijuana metabolite, are normalized to the urine creatinine (CN) concentration to reduce the variability of drug measurement attributable to urine dilution. Negative values indicate decreased use. Change = (Week 8 value - Week 0 value).
measure: Change From Week 0 in Drinking Quantity and Frequency Using Drinks Per Week at Week 8
time frame: Week 0 and Week 8
description: Standard drinks are equivalent to 14 grams of pure alcohol and number of drinks are assessed with Timeline Follow-Back (TLFB) methods. Change = (Week 8 - Week 0). More negative values indicate less use of alcohol.
arm group label: Experimental: aprepitant 125 mg/day
arm group type: Active Comparator
description: 125 mg aprepitant daily for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.
arm group label: Placebo 125mg/d
arm group type: Placebo Comparator
description: Matched placebo pill given daily for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.
intervention type: Drug
intervention name: aprepitant
description: 125 mg daily for 8 weeks.
arm group label: Experimental: aprepitant 125 mg/day
other name: Emend
intervention type: Drug
intervention name: Placebo
description: Placebo daily for 8 weeks.
arm group label: Placebo 125mg/d
intervention type: Behavioral
intervention name: Manual-guided behavioral counseling
description: Standardized manual-guided behavioral counseling performed 1 time per week for 8 weeks in conjunction with study drug or placebo.
arm group label: Experimental: aprepitant 125 mg/day
arm group label: Placebo 125mg/d
other name: Manual-guided therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 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: Principal Investigator
investigator affiliation: The Scripps Research Institute
investigator full name: Barbara J. Mason
investigator title: Principal Investigator
mesh term: Marijuana Abuse
mesh term: Alcoholism
mesh term: Aprepitant
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 