<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/NCT01704196</url>
  </required_header>
  <id_info>
    <org_study_id>NIDA/VA CS#1031</org_study_id>
    <nct_id>NCT01704196</nct_id>
  </id_info>
  <brief_title>A Multi-Center Trial of Nepicastat for Cocaine Dependence</brief_title>
  <official_title>Phase 2, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Trial of Nepicastat for Cocaine Dependence</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Institute on Drug Abuse (NIDA)</agency>
      <agency_class>NIH</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Institute on Drug Abuse (NIDA)</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to evaluate the safety and efficacy of Nepicastat in improving&#xD;
      the number of subjects that achieve abstinence from cocaine and reducing cocaine use in&#xD;
      subjects with cocaine dependence.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 2013</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">August 2014</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>Abstinence (Weeks 10 - 11)</measure>
    <time_frame>Weeks 10 - 11</time_frame>
    <description>Number of subjects that abstained from cocaine from weeks 10 through 11</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Reduction in Use (Weeks 1 - 11)</measure>
    <time_frame>Baseline through week 11</time_frame>
    <description>Proportion of Subjects with a 50% or More Reduction in Cocaine Use from Baseline through week 11</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">179</enrollment>
  <condition>Cocaine Dependence</condition>
  <arm_group>
    <arm_group_label>Nepicastat</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Nepicastat 120mg and 100mg riboflavin (once per day) for 11 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo capsule containing 100mg riboflavin (once per day) for 11 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nepicastat</intervention_name>
    <description>120 mg of active drug and 100mg of riboflavin daily for 11 weeks or matching placebo containing 100mg of riboflavin daily for 11 weeks.</description>
    <arm_group_label>Nepicastat</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Be at least 18 years of age&#xD;
&#xD;
          -  Is seeking treatment for cocaine dependence&#xD;
&#xD;
          -  Is able to understand and provide written informed consent&#xD;
&#xD;
          -  Has completed all psychological assessments and procedures required during the 7 - 14&#xD;
             day screening period&#xD;
&#xD;
          -  If female, agrees to use an acceptable method of birth control&#xD;
&#xD;
          -  Is, in the opinion of the Investigator, likely to complete the 11-week Treatment Phase&#xD;
             of the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Please contact the study site for more information&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Matrix Institute on Addictions</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VA San Diego Healthcare System</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92161</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VA Medical Center - Denver, CO</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80220</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mountain Manor Treatment Center at Baltimore</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pacific Institute for Research and Evaluation</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Columbia University Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10019</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cincinnati Addiction Research Center</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45220</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pennsylvania - Treatment Research Center</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Michael E. DeBakey VA Medical Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>George E. Wahlen VA Medical Center</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84148</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>September 17, 2012</study_first_submitted>
  <study_first_submitted_qc>October 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 11, 2012</study_first_posted>
  <results_first_submitted>January 4, 2017</results_first_submitted>
  <results_first_submitted_qc>April 7, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">May 18, 2017</results_first_posted>
  <last_update_submitted>April 7, 2017</last_update_submitted>
  <last_update_submitted_qc>April 7, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 18, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cocaine-Related Disorders</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Nepicastat</title>
          <description>Nepicastat 120mg and 100mg riboflavin (once per day) for 11 weeks&#xD;
Nepicastat: 120 mg of active drug and 100mg of riboflavin daily for 11 weeks or matching placebo containing 100mg of riboflavin daily for 11 weeks.</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>Placebo capsule containing 100mg riboflavin (once per day) for 11 weeks.&#xD;
Placebo</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="90"/>
                <participants group_id="P2" count="89"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="71"/>
                <participants group_id="P2" count="65"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="24"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Nepicastat</title>
          <description>Nepicastat 120mg and 100mg riboflavin (once per day) for 11 weeks&#xD;
Nepicastat: 120 mg of active drug and 100mg of riboflavin daily for 11 weeks or matching placebo containing 100mg of riboflavin daily for 11 weeks.</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>Placebo capsule containing 100mg riboflavin (once per day) for 11 weeks.&#xD;
Placebo</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="90"/>
            <count group_id="B2" value="89"/>
            <count group_id="B3" value="179"/>
          </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="50.8" spread="8.2"/>
                    <measurement group_id="B2" value="49.0" spread="8.2"/>
                    <measurement group_id="B3" value="49.9" spread="8.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="27"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="75"/>
                    <measurement group_id="B2" value="77"/>
                    <measurement group_id="B3" value="152"/>
                  </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="90"/>
                    <measurement group_id="B2" value="89"/>
                    <measurement group_id="B3" value="179"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Abstinence (Weeks 10 - 11)</title>
        <description>Number of subjects that abstained from cocaine from weeks 10 through 11</description>
        <time_frame>Weeks 10 - 11</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Nepicastat</title>
            <description>Nepicastat 120mg and 100mg riboflavin (once per day) for 11 weeks&#xD;
Nepicastat: 120 mg of active drug and 100mg of riboflavin daily for 11 weeks or matching placebo containing 100mg of riboflavin daily for 11 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo capsule containing 100mg riboflavin (once per day) for 11 weeks.&#xD;
Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Abstinence (Weeks 10 - 11)</title>
          <description>Number of subjects that abstained from cocaine from weeks 10 through 11</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="90"/>
                <count group_id="O2" value="89"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Reduction in Use (Weeks 1 - 11)</title>
        <description>Proportion of Subjects with a 50% or More Reduction in Cocaine Use from Baseline through week 11</description>
        <time_frame>Baseline through week 11</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Nepicastat</title>
            <description>Nepicastat 120mg and 100mg riboflavin (once per day) for 11 weeks&#xD;
Nepicastat: 120 mg of active drug and 100mg of riboflavin daily for 11 weeks or matching placebo containing 100mg of riboflavin daily for 11 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo capsule containing 100mg riboflavin (once per day) for 11 weeks.&#xD;
Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Reduction in Use (Weeks 1 - 11)</title>
          <description>Proportion of Subjects with a 50% or More Reduction in Cocaine Use from Baseline through week 11</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="90"/>
                <count group_id="O2" value="89"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Nepicastat</title>
          <description>Nepicastat 120mg and 100mg riboflavin (once per day) for 11 weeks&#xD;
Nepicastat: 120 mg of active drug and 100mg of riboflavin daily for 11 weeks or matching placebo containing 100mg of riboflavin daily for 11 weeks.</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>Placebo capsule containing 100mg riboflavin (once per day) for 11 weeks.&#xD;
Placebo</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="89"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Hospitalization for Chest Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="89"/>
              </event>
              <event>
                <sub_title>Hospitalization for Congestive Heart Failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="89"/>
              </event>
              <event>
                <sub_title>Atrial Flutter</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="89"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Hospitalization for acute pancreatitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="89"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Hospitalization for the flu</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="89"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Hospitalization for Concussion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="89"/>
              </event>
              <event>
                <sub_title>Hospitalization for head wounds and cracked ribs</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="89"/>
              </event>
              <event>
                <sub_title>Hospitalization for stab wound</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="89"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Hospitalization for depression and suicidality</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="89"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Hospitalization for angioedema secondary to lisinopril</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="89"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>1</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="80" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="67" subjects_at_risk="89"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="89"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Ear pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="89"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Blurred Vision</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="89"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="90"/>
                <counts group_id="E2" events="10" subjects_affected="7" subjects_at_risk="89"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="7" subjects_affected="6" subjects_at_risk="90"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="89"/>
              </event>
              <event>
                <sub_title>Abdominal Discomfort</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="90"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="89"/>
              </event>
              <event>
                <sub_title>Toothache</sub_title>
                <counts group_id="E1" events="8" subjects_affected="7" subjects_at_risk="90"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="89"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="90"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="89"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="90"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="89"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="90"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="89"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="90"/>
                <counts group_id="E2" events="10" subjects_affected="9" subjects_at_risk="89"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="90"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="89"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="20" subjects_affected="16" subjects_at_risk="90"/>
                <counts group_id="E2" events="17" subjects_affected="11" subjects_at_risk="89"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="10" subjects_affected="8" subjects_at_risk="90"/>
                <counts group_id="E2" events="9" subjects_affected="7" subjects_at_risk="89"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="8" subjects_affected="7" subjects_at_risk="90"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="89"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="9" subjects_affected="6" subjects_at_risk="90"/>
                <counts group_id="E2" events="9" subjects_affected="7" subjects_at_risk="89"/>
              </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>Liza Zeinert</name_or_title>
      <organization>National Institute on Drug Abuse</organization>
      <phone>301-443-1138</phone>
      <email>liza.zeinert@nih.gov</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/NCT01704196
org study id: NIDA/VA CS#1031
nct id: NCT01704196
lead sponsor: 
has dmc: Yes
The objective of this study is to evaluate the safety and efficacy of Nepicastat in improving
      the number of subjects that achieve abstinence from cocaine and reducing cocaine use in
      subjects with cocaine dependence.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Abstinence (Weeks 10 - 11)
time frame: Weeks 10 - 11
description: Number of subjects that abstained from cocaine from weeks 10 through 11
measure: Reduction in Use (Weeks 1 - 11)
time frame: Baseline through week 11
description: Proportion of Subjects with a 50% or More Reduction in Cocaine Use from Baseline through week 11
arm group label: Nepicastat
arm group type: Active Comparator
description: Nepicastat 120mg and 100mg riboflavin (once per day) for 11 weeks
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo capsule containing 100mg riboflavin (once per day) for 11 weeks.
intervention type: Drug
intervention name: Nepicastat
description: 120 mg of active drug and 100mg of riboflavin daily for 11 weeks or matching placebo containing 100mg of riboflavin daily for 11 weeks.
arm group label: Nepicastat
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
facility: 
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country: United States
responsible party type: Sponsor
mesh term: Cocaine-Related Disorders
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 