<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/NCT01721330</url>
  </required_header>
  <id_info>
    <org_study_id>2012P-002252</org_study_id>
    <nct_id>NCT01721330</nct_id>
  </id_info>
  <brief_title>A Double-Blind Comparison of Naltrexone and Placebo in Adults With Attention Deficit Hyperactivity Disorder</brief_title>
  <official_title>A Double-Blind Comparison of Naltrexone and Placebo in Adults With Attention Deficit Hyperactivity Disorder</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Massachusetts General Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary aim of this study is to assess whether naltrexone as a monotherapy is effective&#xD;
      in treating ADHD in adults. Medications that increase dopamine are often effective treatments&#xD;
      for ADHD. Since naltrexone is a kappa opioid receptor antagonist, it increases dopamine in&#xD;
      the brain. The investigators predict that naltrexone as a monotherapy will be effective for&#xD;
      ADHD symptoms in adults with ADHD.&#xD;
&#xD;
      The investigators also plan to assess the effects of naltrexone on dopamine as measured by&#xD;
      changes in serum prolactin. The investigators predict that naltrexone will increase dopamine&#xD;
      as indexed by decreases in serum prolactin. This study will be a six-week, double-blind,&#xD;
      placebo-controlled pilot study with adults 18-55 years of age with ADHD.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This will be a six-week, randomized, double-blind, placebo-controlled, parallel design study&#xD;
      of adult ADHD with naltrexone monotherapy. Eligible and consenting subjects will be recruited&#xD;
      into the study. The first visit will consist of a meeting with a study clinician who obtains&#xD;
      consent, assesses for eligibility, and completes study rating scales. After this evaluation,&#xD;
      subjects will complete a neuropsychological assessment and study rating scales (two hours;&#xD;
      this visit can take place over multiple days, if necessary). Subjects will then be randomized&#xD;
      to naltrexone (50 mg) once a day with breakfast or placebo at a ratio of 1:1 to be increased,&#xD;
      if tolerated, to 100 mg by week 1.&#xD;
&#xD;
      Blood will be drawn for prolactin, basic metabolic panel, CBC, and LFT's at pre-baseline and&#xD;
      upon completion of the study. Ten cc's (approximately two teaspoons) of blood will be&#xD;
      required for the basic metabolic panel, CBC, and LFT's at each drawing. An additional five&#xD;
      cc's (approximately one teaspoon) of blood will be required for laboratory testing of&#xD;
      prolactin levels at each drawing. Dipstick urine drug testing will be done at pre-baseline.&#xD;
&#xD;
      Women of child bearing age will also have a urine pregnancy test at pre-baseline.&#xD;
&#xD;
      Although every effort will be made to encourage subjects to keep regularly scheduled&#xD;
      appointments, in the event that a subject is unable to come into the office within a&#xD;
      reasonable timeframe of a scheduled visit, and the treating research clinician feels that&#xD;
      subject safety will not be jeopardized by doing so, the clinician can conduct the visit with&#xD;
      the subject over the telephone. However, study evaluation visit (pre-baseline), baseline&#xD;
      visit, mid-point visit (week 3), or the final study visit may not be conducted over the&#xD;
      phone. Additionally, phone visits may not occur for two consecutive visits.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Competing studies&#xD;
  </why_stopped>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">February 2015</completion_date>
  <primary_completion_date type="Actual">February 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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Adult Investigator Symptom Rating Scale (AISRS) Score</measure>
    <time_frame>6 weeks</time_frame>
    <description>The AISRS is an 18-item clinician rating scale to evaluate individual ADHD symptoms on a scale of 0 (none) to 3 (severe). The total sum ranges from 0 (no ADHD symptoms) to 54 (extremely severe ADHD symptoms). We measured the change in AISRS score from baseline to week 6.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">3</enrollment>
  <condition>ADHD</condition>
  <condition>Attention Deficit Hyperactivity Disorder</condition>
  <arm_group>
    <arm_group_label>Naltrexone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Active Naltrexone administered twice daily up to a maximum total dose of 100mg/day.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Naltrexone-masked placebo administered twice daily up to a maximum total dose of 100mg/day.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Naltrexone</intervention_name>
    <description>Up to 100mg of Naltrexone once a day for 6 weeks</description>
    <arm_group_label>Naltrexone</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo twice a day for 6 weeks</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          1. Male and female outpatients 18-55 years of age.&#xD;
&#xD;
          2. Diagnosis of ADHD, by Diagnostic and Statistical Manual-IV (DSM-IV) by clinical&#xD;
             evaluation by an expert clinician.&#xD;
&#xD;
          3. A CGI of 7 (among the most extremely ill patients) at the pre-baseline visit is&#xD;
             exclusionary, and any subject who presents a CGI-S of 7 at any point during the study&#xD;
             will be removed from participation.&#xD;
&#xD;
          4. Subjects presenting with a CGI-S score of 6 (severely ill) at two consecutive visits&#xD;
             after week 2 will be dropped from the study (i.e. A subject with a CGI of 6 at his/her&#xD;
             week 3 visit and at week 4 visit will be dropped from the study at the week 4 visit).&#xD;
             Subjects who are dropped for severe or worsening symptoms after exposure to the study&#xD;
             medication will receive free follow up care as described in the detailed protocol and&#xD;
             protocol summary.&#xD;
&#xD;
          5. Subjects treated for anxiety disorders and depression who are on a stable medication&#xD;
             regimen for at least one month, and who have a disorder-specific CGI-Severity score ≤&#xD;
             3 (mildly ill) and who have a score on the Hamilton-Depression and Hamilton-Anxiety&#xD;
             rating scales below 15 (mild range).&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          1. Any clinically unstable psychiatric conditions including any history of psychosis or&#xD;
             mania, suicidality, sociopathy, criminality, or delinquency.&#xD;
&#xD;
          2. Current (last 3 months) substance use disorders (alcohol or drugs),&#xD;
&#xD;
          3. Medical condition or treatment that will either jeopardize subject safety or affect&#xD;
             the scientific merit of the study including cardiovascular disease, current untreated&#xD;
             hypertension, or history of renal or hepatic impairment.&#xD;
&#xD;
          4. A condition that will or may require treatment with opioid analgesics.&#xD;
&#xD;
          5. Clinically significant abnormal baseline laboratory LFT's, which is defined as LFT's&#xD;
             greater than the ULN.&#xD;
&#xD;
          6. Mental retardation (IQ &lt; 80).&#xD;
&#xD;
          7. Organic brain disorders including delirium, dementia, seizures, stroke, neurosurgery,&#xD;
             and head trauma with loss of consciousness.&#xD;
&#xD;
          8. Pregnant or nursing females.&#xD;
&#xD;
          9. Subjects with current adequate treatment for ADHD.&#xD;
&#xD;
         10. Any other concomitant medication with primarily central nervous system activity other&#xD;
             than specified in Concomitant Medication portion of the protocol (a stable and&#xD;
             effective treatment regimen of an SSRI or benzodiazepine is permitted per clinical&#xD;
             review).&#xD;
&#xD;
         11. Non-English speaking subjects will not be allowed into the study for the following&#xD;
             reasons:&#xD;
&#xD;
               1. The assessment instruments are unavailable and have not been adequately&#xD;
                  standardized in other languages;&#xD;
&#xD;
               2. Even if such translation services were available, the assessments in the English&#xD;
                  language conducted by English-speaking clinicians and raters with&#xD;
                  English-speaking subjects are already extremely time-consuming, lasting many&#xD;
                  hours, making it unfeasible, unrealistic, and of dubious clinical validity to&#xD;
                  conduct them with a translator with non-English-speaking subjects;&#xD;
&#xD;
               3. Psychiatric questionnaires and evaluations are taxing, and adding the complexity&#xD;
                  of a translator has the potential to make the patient experience even more&#xD;
                  exhausting.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 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>Cambridge</city>
        <state>Massachusetts</state>
        <zip>02138</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2016</verification_date>
  <study_first_submitted>October 30, 2012</study_first_submitted>
  <study_first_submitted_qc>November 1, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 4, 2012</study_first_posted>
  <results_first_submitted>March 14, 2016</results_first_submitted>
  <results_first_submitted_qc>March 14, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">April 12, 2016</results_first_posted>
  <last_update_submitted>April 27, 2016</last_update_submitted>
  <last_update_submitted_qc>April 27, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 27, 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>Attention Deficit Hyperactivity Disorder</keyword>
  <keyword>Psychopharmacology</keyword>
  <keyword>Psychiatry</keyword>
  <keyword>Non-stimulant treatment</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyperkinesis</mesh_term>
    <mesh_term>Attention Deficit Disorder with Hyperactivity</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Naltrexone</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Naltrexone</title>
          <description>Active Naltrexone administered twice daily up to a maximum total dose of 100mg/day.&#xD;
Naltrexone: Up to 100mg of Naltrexone once a day for 6 weeks</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>Naltrexone-masked placebo administered twice daily up to a maximum total dose of 100mg/day.&#xD;
Placebo: Placebo twice a day for 6 weeks</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <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>
      <group_list>
        <group group_id="B1">
          <title>Naltrexone</title>
          <description>Active Naltrexone administered twice daily up to a maximum total dose of 100mg/day.&#xD;
Naltrexone: Up to 100mg of Naltrexone once a day for 6 weeks</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>Naltrexone-masked placebo administered twice daily up to a maximum total dose of 100mg/day.&#xD;
Placebo: Placebo twice a day for 6 weeks</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="1"/>
            <count group_id="B2" value="2"/>
            <count group_id="B3" value="3"/>
          </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="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </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="36.33" spread="NA">Only one subject</measurement>
                    <measurement group_id="B2" value="32.21" spread="2.13"/>
                    <measurement group_id="B3" value="33.58" spread="2.61"/>
                  </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="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</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_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="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not 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>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="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </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="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</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>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_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Adult Investigator Symptom Rating Scale (AISRS) Score</title>
        <description>The AISRS is an 18-item clinician rating scale to evaluate individual ADHD symptoms on a scale of 0 (none) to 3 (severe). The total sum ranges from 0 (no ADHD symptoms) to 54 (extremely severe ADHD symptoms). We measured the change in AISRS score from baseline to week 6.</description>
        <time_frame>6 weeks</time_frame>
        <population>One subject withdrew from the study before receiving study medication, so data from only two subjects was analyzed (one subject in each group). Therefore, means and standard deviations were not calculated.</population>
        <group_list>
          <group group_id="O1">
            <title>Naltrexone</title>
            <description>Active Naltrexone administered twice daily up to a maximum total dose of 100mg/day.&#xD;
Naltrexone: Up to 100mg of Naltrexone once a day for 6 weeks</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Naltrexone-masked placebo administered twice daily up to a maximum total dose of 100mg/day.&#xD;
Placebo: Placebo twice a day for 6 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Adult Investigator Symptom Rating Scale (AISRS) Score</title>
          <description>The AISRS is an 18-item clinician rating scale to evaluate individual ADHD symptoms on a scale of 0 (none) to 3 (severe). The total sum ranges from 0 (no ADHD symptoms) to 54 (extremely severe ADHD symptoms). We measured the change in AISRS score from baseline to week 6.</description>
          <population>One subject withdrew from the study before receiving study medication, so data from only two subjects was analyzed (one subject in each group). Therefore, means and standard deviations were not calculated.</population>
          <units>units on a scale</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.0"/>
                    <measurement group_id="O2" value="-5.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Naltrexone</title>
          <description>Active Naltrexone administered twice daily up to a maximum total dose of 100mg/day.&#xD;
Naltrexone: Up to 100mg of Naltrexone once a day for 6 weeks</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>Naltrexone-masked placebo administered twice daily up to a maximum total dose of 100mg/day.&#xD;
Placebo: Placebo twice a day for 6 weeks</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="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="2"/>
              </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="1" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Flu</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Muscle ache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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>
    <limitations_and_caveats>The study was terminated prior to completion due to competing studies. Therefore, only one subject in each group was analyzed.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Leah Feinberg</name_or_title>
      <organization>Massachusetts General Hospital</organization>
      <phone>617-726-4651</phone>
      <email>lkfeinberg@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/NCT01721330
org study id: 2012P-002252
nct id: NCT01721330
lead sponsor: 
has dmc: No
The primary aim of this study is to assess whether naltrexone as a monotherapy is effective
      in treating ADHD in adults. Medications that increase dopamine are often effective treatments
      for ADHD. Since naltrexone is a kappa opioid receptor antagonist, it increases dopamine in
      the brain. The investigators predict that naltrexone as a monotherapy will be effective for
      ADHD symptoms in adults with ADHD.

      The investigators also plan to assess the effects of naltrexone on dopamine as measured by
      changes in serum prolactin. The investigators predict that naltrexone will increase dopamine
      as indexed by decreases in serum prolactin. This study will be a six-week, double-blind,
      placebo-controlled pilot study with adults 18-55 years of age with ADHD.
This will be a six-week, randomized, double-blind, placebo-controlled, parallel design study
      of adult ADHD with naltrexone monotherapy. Eligible and consenting subjects will be recruited
      into the study. The first visit will consist of a meeting with a study clinician who obtains
      consent, assesses for eligibility, and completes study rating scales. After this evaluation,
      subjects will complete a neuropsychological assessment and study rating scales (two hours;
      this visit can take place over multiple days, if necessary). Subjects will then be randomized
      to naltrexone (50 mg) once a day with breakfast or placebo at a ratio of 1:1 to be increased,
      if tolerated, to 100 mg by week 1.

      Blood will be drawn for prolactin, basic metabolic panel, CBC, and LFT's at pre-baseline and
      upon completion of the study. Ten cc's (approximately two teaspoons) of blood will be
      required for the basic metabolic panel, CBC, and LFT's at each drawing. An additional five
      cc's (approximately one teaspoon) of blood will be required for laboratory testing of
      prolactin levels at each drawing. Dipstick urine drug testing will be done at pre-baseline.

      Women of child bearing age will also have a urine pregnancy test at pre-baseline.

      Although every effort will be made to encourage subjects to keep regularly scheduled
      appointments, in the event that a subject is unable to come into the office within a
      reasonable timeframe of a scheduled visit, and the treating research clinician feels that
      subject safety will not be jeopardized by doing so, the clinician can conduct the visit with
      the subject over the telephone. However, study evaluation visit (pre-baseline), baseline
      visit, mid-point visit (week 3), or the final study visit may not be conducted over the
      phone. Additionally, phone visits may not occur for two consecutive visits.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change in Adult Investigator Symptom Rating Scale (AISRS) Score
time frame: 6 weeks
description: The AISRS is an 18-item clinician rating scale to evaluate individual ADHD symptoms on a scale of 0 (none) to 3 (severe). The total sum ranges from 0 (no ADHD symptoms) to 54 (extremely severe ADHD symptoms). We measured the change in AISRS score from baseline to week 6.
arm group label: Naltrexone
arm group type: Active Comparator
description: Active Naltrexone administered twice daily up to a maximum total dose of 100mg/day.
arm group label: Placebo
arm group type: Placebo Comparator
description: Naltrexone-masked placebo administered twice daily up to a maximum total dose of 100mg/day.
intervention type: Drug
intervention name: Naltrexone
description: Up to 100mg of Naltrexone once a day for 6 weeks
arm group label: Naltrexone
intervention type: Drug
intervention name: Placebo
description: Placebo twice a day for 6 weeks
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 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: Hyperkinesis
mesh term: Attention Deficit Disorder with Hyperactivity
mesh term: Naltrexone
sharing ipd: Undecided
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: The study was terminated prior to completion due to competing studies. Therefore, only one subject in each group was analyzed.
point of contact: 