<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/NCT01673594</url>
  </required_header>
  <id_info>
    <org_study_id>2012-P-000918</org_study_id>
    <nct_id>NCT01673594</nct_id>
  </id_info>
  <brief_title>Prevention of Stimulant-Induced Euphoria With an Opioid Receptor Antagonist</brief_title>
  <official_title>Prevention of Stimulant-Induced Euphoria With an Opioid Receptor Antagonist</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>United States Department of Defense</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>Massachusetts General Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to a) assess the efficacy of naltrexone in preventing&#xD;
      stimulant-induced euphoria in adults with ADHD, b) assess whether naltrexone will interfere&#xD;
      with the clinical efficacy of stimulants in treating adults with ADHD, c) assess whether&#xD;
      naltrexone will interfere with the effects of stimulants on neurotransmitter activity. We&#xD;
      predict that naltrexone will successfully prevent stimulant-induced euphoria without&#xD;
      interfering with the ability of stimulants to effectively treat ADHD in adults. This study&#xD;
      will be an 8 -week trial with young adults (18-24) with ADHD.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">June 2015</completion_date>
  <primary_completion_date type="Actual">June 2015</primary_completion_date>
  <phase>Phase 4</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Score on AISRS From Baseline to Week 6</measure>
    <time_frame>Baseline and 6 Weeks</time_frame>
    <description>The Adult ADHD Investigator System Report Scale (AISRS) is an 18-item, DSM-IV symptom Likert scale that measures ADHD symptoms in adults. Each of the individual symptoms of ADHD is rated from 0 to 3 on a scale of severity (3 being more severe symptoms). Total scores range from 0 to 54; higher scores indicate greater symptom severity. Change was calculated as value at baseline minus value at 6 weeks.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Safety</measure>
    <time_frame>6 Weeks</time_frame>
    <description>Number of adverse events throughout the course of the study</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">37</enrollment>
  <condition>ADHD</condition>
  <condition>Stimulant-Induced Euphoria</condition>
  <arm_group>
    <arm_group_label>Naltrexone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Arm 1: Naltrexone + SODAS MPH</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Arm 2: Placebo + SODAS MPH</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SODAS MPH</intervention_name>
    <description>Adults with ADHD will receive open-label SODAS MPH</description>
    <arm_group_label>Naltrexone</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Ritalin LA</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Naltrexone</intervention_name>
    <description>Subjects randomized to the &quot;active&quot; double-blind group will receive Naltrexone HCl</description>
    <arm_group_label>Naltrexone</arm_group_label>
    <other_name>Naltrexone HCl</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion&#xD;
&#xD;
          1. Male and female outpatients&#xD;
&#xD;
          2. age 18-30&#xD;
&#xD;
          3. diagnosis of ADHD by DSM-IV, per clinical evaluation and confirmed by structured&#xD;
             interview&#xD;
&#xD;
          4. likeability response (&gt; 5) on Question #2 of the DRQ-S after an initial test dose of&#xD;
             60 mg of IR MPH.&#xD;
&#xD;
          5. Baseline ADHD severity of &gt; 20 on the Adult ADHD Investigator System Report Scale&#xD;
             (AISRS)&#xD;
&#xD;
          6. Able to participate in blood draws and to swallow pills.&#xD;
&#xD;
          7. Subjects must be considered reliable reporters, must understand the nature of the&#xD;
             study and must sign an informed consent document&#xD;
&#xD;
        Exclusion&#xD;
&#xD;
          1. Any current (last month), non-ADHD Axis I psychiatric conditions&#xD;
&#xD;
          2. Ham-D &gt; 16, BDI &gt; 19, or Ham-A &gt; 21&#xD;
&#xD;
          3. Any clinically significant chronic medical condition&#xD;
&#xD;
          4. any cardiovascular disease or hypertension&#xD;
&#xD;
          5. Clinically significant abnormal baseline laboratory values&#xD;
&#xD;
          6. I.Q. &lt; 80)&#xD;
&#xD;
          7. Organic brain disorders&#xD;
&#xD;
          8. Seizures or tics&#xD;
&#xD;
          9. Pregnant or nursing females&#xD;
&#xD;
         10. Clinically unstable psychiatric conditions (i.e. suicidal behaviors, psychosis)&#xD;
&#xD;
         11. Current or recent (within the past year) substance abuse/dependence&#xD;
&#xD;
         12. patients on other psychotropics&#xD;
&#xD;
         13. Current or prior adequate treatment with MPH&#xD;
&#xD;
         14. known hypersensitivity to methylphenidate&#xD;
&#xD;
         15. Current opioid use (by history and urine screen) or potential need for opioid&#xD;
             analgesics during the study&#xD;
&#xD;
         16. acute hepatitis or liver failure (baseline blood tests).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Thomas J Spencer, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Massachusetts General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>June 21, 2012</study_first_submitted>
  <study_first_submitted_qc>August 23, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2012</study_first_posted>
  <results_first_submitted>June 28, 2016</results_first_submitted>
  <results_first_submitted_qc>October 7, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">November 30, 2016</results_first_posted>
  <last_update_submitted>October 7, 2016</last_update_submitted>
  <last_update_submitted_qc>October 7, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 30, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>Thomas J. Spencer, MD</investigator_full_name>
    <investigator_title>Associate Chief, Clinical and Research Program, Pediatric Psychopharmacology</investigator_title>
  </responsible_party>
  <keyword>ADHD</keyword>
  <keyword>Naltrexone</keyword>
  <keyword>SODAS MPH</keyword>
  <keyword>Stimulant-Induced Euphoria</keyword>
  <keyword>Substance Abuse</keyword>
  <keyword>Adults</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Naltrexone</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Naltrexone</title>
          <description>Arm 1: Naltrexone + SODAS MPH&#xD;
SODAS MPH: Adults with ADHD will receive open-label SODAS MPH&#xD;
Naltrexone: Subjects randomized to the &quot;active&quot; double-blind group will receive Naltrexone HCl</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>Arm 2: Placebo + SODAS MPH&#xD;
SODAS MPH: Adults with ADHD will receive open-label SODAS MPH</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
                <participants group_id="P2" count="19"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="13"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</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_list>
    </participant_flow>

    <baseline>
      <population>Baseline characteristics are reported for subjects who made it to week 3 of the trial and were included in analysis.</population>
      <group_list>
        <group group_id="B1">
          <title>Naltrexone</title>
          <description>Arm 1: Naltrexone + SODAS MPH&#xD;
SODAS MPH: Adults with ADHD will receive open-label SODAS MPH&#xD;
Naltrexone: Subjects randomized to the &quot;active&quot; double-blind group will receive Naltrexone HCl</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>Arm 2: Placebo + SODAS MPH&#xD;
SODAS MPH: Adults with ADHD will receive open-label SODAS MPH</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="15"/>
            <count group_id="B2" value="16"/>
            <count group_id="B3" value="31"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="31"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>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="25.1" spread="2.9"/>
                    <measurement group_id="B2" value="24.4" spread="3.2"/>
                    <measurement group_id="B3" value="24.8" spread="3.0"/>
                  </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="9"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="28"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="23"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Score on AISRS From Baseline to Week 6</title>
        <description>The Adult ADHD Investigator System Report Scale (AISRS) is an 18-item, DSM-IV symptom Likert scale that measures ADHD symptoms in adults. Each of the individual symptoms of ADHD is rated from 0 to 3 on a scale of severity (3 being more severe symptoms). Total scores range from 0 to 54; higher scores indicate greater symptom severity. Change was calculated as value at baseline minus value at 6 weeks.</description>
        <time_frame>Baseline and 6 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Naltrexone</title>
            <description>Arm 1: Naltrexone + SODAS MPH&#xD;
SODAS MPH: Adults with ADHD will receive open-label SODAS MPH&#xD;
Naltrexone: Subjects randomized to the &quot;active&quot; double-blind group will receive Naltrexone HCl</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Arm 2: Placebo + SODAS MPH&#xD;
SODAS MPH: Adults with ADHD will receive open-label SODAS MPH</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Score on AISRS From Baseline to Week 6</title>
          <description>The Adult ADHD Investigator System Report Scale (AISRS) is an 18-item, DSM-IV symptom Likert scale that measures ADHD symptoms in adults. Each of the individual symptoms of ADHD is rated from 0 to 3 on a scale of severity (3 being more severe symptoms). Total scores range from 0 to 54; higher scores indicate greater symptom severity. Change was calculated as value at baseline minus value at 6 weeks.</description>
          <units>units 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="12"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-26.7" spread="10.1"/>
                    <measurement group_id="O2" value="-29.1" spread="10.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Safety</title>
        <description>Number of adverse events throughout the course of the study</description>
        <time_frame>6 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Naltrexone</title>
            <description>Arm 1: Naltrexone + SODAS MPH&#xD;
SODAS MPH: Adults with ADHD will receive open-label SODAS MPH&#xD;
Naltrexone: Subjects randomized to the &quot;active&quot; double-blind group will receive Naltrexone HCl</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Arm 2: Placebo + SODAS MPH&#xD;
SODAS MPH: Adults with ADHD will receive open-label SODAS MPH</description>
          </group>
        </group_list>
        <measure>
          <title>Safety</title>
          <description>Number of adverse events throughout the course of the study</description>
          <units>adverse events</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.73" spread="4.7"/>
                    <measurement group_id="O2" value="4.75" spread="3.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>6 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Naltrexone</title>
          <description>Arm 1: Naltrexone + SODAS MPH&#xD;
SODAS MPH: Adults with ADHD will receive open-label SODAS MPH&#xD;
Naltrexone: Subjects randomized to the &quot;active&quot; double-blind group will receive Naltrexone HCl</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>Arm 2: Placebo + SODAS MPH&#xD;
SODAS MPH: Adults with ADHD will receive open-label SODAS MPH</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="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="18" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="16" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cardiovascular</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea/Vomit/Diarrhea</sub_title>
                <counts group_id="E1" events="19" subjects_affected="12" subjects_at_risk="18"/>
                <counts group_id="E2" events="9" subjects_affected="8" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Cold/Infection/Allergy</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Autonomic: Drool/Sweat</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Mucosal Dryness</sub_title>
                <counts group_id="E1" events="4" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Pressure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Feels Warm</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Tingly Feeling in Head and Chest</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" events="13" subjects_affected="5" subjects_at_risk="18"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Musculoskeletal</sub_title>
                <counts group_id="E1" events="5" subjects_affected="3" subjects_at_risk="18"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="19"/>
              </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="8" subjects_at_risk="18"/>
                <counts group_id="E2" events="16" subjects_affected="7" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="14" subjects_affected="8" subjects_at_risk="18"/>
                <counts group_id="E2" events="13" subjects_affected="7" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Sedation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>DizzyLightheaded</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Extra Pyramidal Symptoms</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Neurological</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased Energy</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="18"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Increased Energy</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Tense/Jittery</sub_title>
                <counts group_id="E1" events="7" subjects_affected="5" subjects_at_risk="18"/>
                <counts group_id="E2" events="5" subjects_affected="3" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Agitated/irritable</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Sad/Down</sub_title>
                <counts group_id="E1" events="5" subjects_affected="3" subjects_at_risk="18"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Anxious/Worried</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Unable to Feel Emotions</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Menstrual Cramps</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dermatological</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
              </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>Research Regulatory Coordinator</name_or_title>
      <organization>Massachusetts General Hospital</organization>
      <phone>617-726-4651</phone>
      <email>apulli@mgh.harvard.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/NCT01673594
org study id: 2012-P-000918
nct id: NCT01673594
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this study is to a) assess the efficacy of naltrexone in preventing
      stimulant-induced euphoria in adults with ADHD, b) assess whether naltrexone will interfere
      with the clinical efficacy of stimulants in treating adults with ADHD, c) assess whether
      naltrexone will interfere with the effects of stimulants on neurotransmitter activity. We
      predict that naltrexone will successfully prevent stimulant-induced euphoria without
      interfering with the ability of stimulants to effectively treat ADHD in adults. This study
      will be an 8 -week trial with young adults (18-24) with ADHD.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change in Score on AISRS From Baseline to Week 6
time frame: Baseline and 6 Weeks
description: The Adult ADHD Investigator System Report Scale (AISRS) is an 18-item, DSM-IV symptom Likert scale that measures ADHD symptoms in adults. Each of the individual symptoms of ADHD is rated from 0 to 3 on a scale of severity (3 being more severe symptoms). Total scores range from 0 to 54; higher scores indicate greater symptom severity. Change was calculated as value at baseline minus value at 6 weeks.
measure: Safety
time frame: 6 Weeks
description: Number of adverse events throughout the course of the study
arm group label: Naltrexone
arm group type: Experimental
description: Arm 1: Naltrexone + SODAS MPH
arm group label: Placebo
arm group type: Placebo Comparator
description: Arm 2: Placebo + SODAS MPH
intervention type: Drug
intervention name: SODAS MPH
description: Adults with ADHD will receive open-label SODAS MPH
arm group label: Naltrexone
arm group label: Placebo
other name: Ritalin LA
intervention type: Drug
intervention name: Naltrexone
description: Subjects randomized to the "active" double-blind group will receive Naltrexone HCl
arm group label: Naltrexone
other name: Naltrexone HCl
criteria: 
gender: All
minimum age: 18 Years
maximum age: 30 Years
healthy volunteers: No
last name: Thomas J Spencer, MD
role: Principal Investigator
affiliation: Massachusetts General Hospital
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: Thomas J. Spencer, MD
investigator title: Associate Chief, Clinical and Research Program, Pediatric Psychopharmacology
mesh term: Naltrexone
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 