<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/NCT02978417</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00074507</org_study_id>
    <secondary_id>69665</secondary_id>
    <nct_id>NCT02978417</nct_id>
  </id_info>
  <brief_title>Feasibility Study of Extended-release Naltrexone (Vivitrol) in Drug Court Settings</brief_title>
  <acronym>DC</acronym>
  <official_title>A Feasibility Study for Testing the Effects of Extended-release Naltrexone (Vivitrol) on Recidivism and Other Participant Outcomes in Drug Court Settings</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Laura and John Arnold Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Alkermes, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>FHR (Fellowship Health Resources, Inc.)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Drug Treatment Court (Wake County, NC)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Duke University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      In preparation for a large-scale randomized controlled trial (RCT) of Vivitrol® effectiveness&#xD;
      in drug courts, investigators propose a feasibility study in the Wake County, North Carolina&#xD;
      drug court, where an estimated 50% of clients are opioid dependent.&#xD;
&#xD;
      Aim 1: Pilot RCT. Pilot-test the delivery of Vivitrol® treatment for 10-20 interested and&#xD;
      eligible clients of the Wake County Drug Court.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Aim 1. Pilot RCT. The pilot delivery of Vivitrol® in the Wake County Drug Court will be&#xD;
      carried out with 20-40 eligible drug court clients under treatment by Fellowship Health&#xD;
      Resources, Inc. (FHR), the community behavioral health treatment agency that is the&#xD;
      contracted treatment provider for the Wake County Drug Court. Participants will be randomized&#xD;
      in equal number to receive Vivitrol® plus treatment as usual (TAU) or TAU only. TAU for drug&#xD;
      court clients receiving services at FHR includes psychosocial treatment such as individual or&#xD;
      group therapy, and sometimes also oral naltrexone for clients who are medically eligible and&#xD;
      interested in taking the medication, the cost of which is covered by the agency for uninsured&#xD;
      clients. (FHR currently administers Vivitrol® for a small number of interested agency clients&#xD;
      with health insurance that covers the medication; the vast majority of their drug court&#xD;
      clients are uninsured and so have no real access to the extended-release formulation due to&#xD;
      its high cost.) Vivitrol® is an FDA-approved extended-release injectable form of naltrexone.&#xD;
      Naltrexone is also available in oral, but not extended release, form. Naltrexone is an opioid&#xD;
      antagonist that &quot;blocks&quot; opioid receptors in the brain to stop pleasurable feelings&#xD;
      associated with taking opioids. Potentially eligible subjects will be drug court-referred FHR&#xD;
      clients willing and eligible to take Vivitrol®, and willing to be randomly assigned to&#xD;
      Vivitrol® or TAU. Potential subjects already under treatment with oral naltrexone at FHR&#xD;
      would be eligible to enter the study if willing to switch to injectable Vivitrol® if randomly&#xD;
      assigned. Study subjects who are randomized to Vivitrol® would receive a once-monthly&#xD;
      injection of Vivitrol® for 12 months, or less if they decide to stop receiving Vivitrol® or&#xD;
      to drop out of the study. Those randomized to TAU would continue with treatment as before,&#xD;
      which could including (1) staying on oral naltrexone if already on it, (2) considering&#xD;
      starting oral naltrexone, if interested, or (3) continuing with psychosocial treatment only.&#xD;
      The Vivitrol® will be administered by study medical personnel at FHR. Randomization to the&#xD;
      Vivitrol® arm would add urine pregnancy testing to FHR's existing Vivitrol® medical&#xD;
      evaluation protocol and consent process, which currently screens for pregnancy without&#xD;
      requiring a urine test. A urine pregnancy test will be administered once per month for female&#xD;
      study participants of child-bearing age who are in the Vivitrol® group. All drug court&#xD;
      clients, including study participants in both study groups, have urine drug tests at least&#xD;
      once per week as part of program participation.&#xD;
&#xD;
      In addition to participating in Vivitrol® and psychosocial treatment, pilot RCT participants&#xD;
      will provide consent for FHR and the drug court to share information with the study team&#xD;
      about their demographic and clinical characteristics, treatment participation (e.g.,&#xD;
      outpatient group therapy), and court-related events (e.g., type of conviction that led to&#xD;
      their drug court participation, missed drug court appointments, sanctions for program&#xD;
      violations, and the results of drug screens).&#xD;
&#xD;
      Participants will also provide two face-to-face interviews at baseline and 6 months after&#xD;
      baseline, about their interest and experience in Vivitrol® and/or other medication-assisted&#xD;
      treatment (MAT), other treatment preferences, level of functioning, quality of life, and&#xD;
      engagement in employment or education.&#xD;
&#xD;
      Outcome measures include treatment participation, compliance with drug court conditions,&#xD;
      arrests and incarcerations, treatment satisfaction, and self-reported subjective measures of&#xD;
      functioning and quality of life.&#xD;
&#xD;
      If a participant chooses not to participate in the study at any time, it will not affect&#xD;
      his/her relationship with the court, FHR, right to health care, or participation in the study&#xD;
      interview data collection. Site staff will follow participants for the purposes of collecting&#xD;
      research and safety information. Investigators discontinue Vivitrol® or oral naltrexone in&#xD;
      circumstances such as: adverse reactions to the medication; a change in medical status that&#xD;
      makes it unsafe for a participant to continue receiving the medication, including pregnancy;&#xD;
      or a participant becoming ill during the study. Participants who discontinue Vivitrol® or&#xD;
      oral naltrexone for any reason may continue to participate in interviews for the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 21, 2017</start_date>
  <completion_date type="Actual">June 30, 2019</completion_date>
  <primary_completion_date type="Actual">June 30, 2019</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With New Arrests</measure>
    <time_frame>12 months</time_frame>
    <description>Any new arrests during the 12-month study period. This information will be collected from administrative records.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With New Incarcerations</measure>
    <time_frame>12 months</time_frame>
    <description>Any new incarceration during the 12-month study period. This information will be collected from administrative records.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Positive Drug Screens</measure>
    <time_frame>12 months</time_frame>
    <description>Number of times a client had a positive drug screen. This information will be collected from administrative records.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Sanctions Imposed by the Court</measure>
    <time_frame>12 months</time_frame>
    <description>Number of sanctions imposed by the court (e.g., brief stays in jail). This information will be collected from administrative records.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Missed Court Appointments</measure>
    <time_frame>12 months</time_frame>
    <description>Number of missed court appointments during the 12-month study period. This information will be collected from administrative records.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vivitrol Participation</measure>
    <time_frame>12 months</time_frame>
    <description>Number of Vivitrol injections from either arm of study. This information will be collected from administrative records.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment Participation (Non-Vivitrol)</measure>
    <time_frame>12 months</time_frame>
    <description>Number of oral naltrexone monthly prescriptions from either arm of study. This information will be collected from administrative records.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Subjective Functioning: Medical Status</measure>
    <time_frame>Baseline, 6 months</time_frame>
    <description>Subjective assessment of medical status using the Addiction Severity Index (ASI) Lite (a single measure with multiple domains) collected via interviews at baseline and approximately six months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Reported Improvement in Subjective Functioning: Employment/Support Status</measure>
    <time_frame>Baseline, 6 months</time_frame>
    <description>Subjective assessment of employment opportunities collected via interviews at baseline and approximately six months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Reported Improvement in Substance Use</measure>
    <time_frame>Baseline, 6 months</time_frame>
    <description>Subjective assessment of alcohol/drug use in past 30 days collected via interviews at baseline and approximately six months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Reported Illegal Behavior</measure>
    <time_frame>approximately 6 months</time_frame>
    <description>Subjective assessment of illegal behavior using the question, &quot;Have you done anything that was against the law in the last 30 days?&quot; collected via interviews approximately six months after baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Reported Improvement in Subjective Functioning: Family/Social Relationships</measure>
    <time_frame>Baseline, approximately 6 months</time_frame>
    <description>Subjective assessment of family and social relationships using a single question about satisfaction with relationships over the past 30 days collected via interviews at baseline and approximately six months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Subjective Functioning: Psychiatric Status</measure>
    <time_frame>Baseline, approximately 6 months</time_frame>
    <description>Subjective assessment of psychiatric status using the Addiction Severity Index (ASI) Lite (a single measure with multiple domains) collected via interviews at baseline and approximately six months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment Satisfaction Score</measure>
    <time_frame>Approximately 6 months</time_frame>
    <description>Reported as average of 12-item treatment satisfaction score at approximately six months. A score of 5 indicates strong agreement with positive statements about treatment satisfaction; a score of 0 indicates strong disagreement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Medication-assisted Treatment (MAT) Attitudes</measure>
    <time_frame>Baseline, approximately 6 months</time_frame>
    <description>Change in MAT attitudes from baseline to follow-up. The average score of 4 questions about MAT for substance use disorder were calculated at baseline and follow-up, and the average score at baseline was subtracted from the average score at follow-up. The averages are based on questions for which a score of 5 indicates strong agreement with statements about MAT; a score of 1 indicates strong disagreement with such statements.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">14</enrollment>
  <condition>Opioid-Related Disorders</condition>
  <arm_group>
    <arm_group_label>Vivitrol</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>All drug court clients in the pilot RCT will receive standard psychosocial treatment for opioid dependence from FHR as part of their drug court program participation. Participants randomized to Vivitrol® will receive standard treatment along with monthly Vivitrol® injections administered by study staff at outpatient visits. Vivitrol® is naltrexone for extended-release injectable suspension. It is an injectable suspension containing 380 mg of naltrexone in a microsphere formulation and 4 mL diluent. The recommended dose of Vivitrol® is 380 mg delivered intramuscularly every 4 weeks or once a month. The injection should be administered by a healthcare provider as an intramuscular (IM) gluteal injection, alternating buttocks for each subsequent injection (see Links section of PRS for more information about Vivitrol).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Oral naltrexone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects randomized to oral naltrexone in addition to standard psychosocial treatment for opioid dependence from FHR as part of their drug court program participation. Oral naltrexone is the daily tablet formulation naltrexone that carries the same risks and benefits as the long-acting injectable formulation (Vivitrol®), except it does not have any of the risks related to injection (discomfort, potential for infection). Oral naltrexone is administered and provided by FHR to interested and eligible clients as part of the range of their usual care services.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Naltrexone for extended-release injectable suspension</intervention_name>
    <description>Opioid-dependent Drug Court clients enrolled in the study will receive monthly injections of Vivitrol for up to 12 months if they continue to be medically eligible and willing.</description>
    <arm_group_label>Vivitrol</arm_group_label>
    <other_name>Vivitrol</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oral naltrexone</intervention_name>
    <description>Opioid-dependent Drug Court clients enrolled in the study will receive prescriptions for oral naltrexone for up to 12 months if they continue to be medically eligible and willing.</description>
    <arm_group_label>Oral naltrexone</arm_group_label>
    <other_name>Revia</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Client of Wake County Drug Treatment Court&#xD;
&#xD;
          -  Interested in medication-assisted treatment for opioid dependence&#xD;
&#xD;
          -  18-65 years old&#xD;
&#xD;
          -  understands and speaks English&#xD;
&#xD;
          -  understands that study participation is fully voluntary, with no effect on court&#xD;
             standing&#xD;
&#xD;
          -  willing and able to give written informed consent&#xD;
&#xD;
          -  has an opioid use disorder (DSM-5 diagnosis of moderate or severe opioid use disorder)&#xD;
&#xD;
          -  has at least 6 months remaining before anticipated Drug Court graduation&#xD;
&#xD;
          -  (if female) does not intend to become pregnant or breastfeeding during the study&#xD;
             period and is willing to adhere to contraception requirements during the study period&#xD;
&#xD;
          -  is willing to adhere to the study requirements&#xD;
&#xD;
          -  Has at least 7-10 days without opioid use before beginning extended-release injectable&#xD;
             naltrexone given that detoxification from opioids before initiating or resuming&#xD;
             extended-release injectable naltrexone is necessary to prevent withdrawal.&#xD;
&#xD;
        Exclusion Criteria*:&#xD;
&#xD;
          -  Is pregnant (i.e., has a positive pregnancy test), planning to become pregnant, or&#xD;
             breastfeeding during the study&#xD;
&#xD;
          -  Has a positive urine drug test for opioids, buprenorphine or methadone at the&#xD;
             beginning of treatment and before each Vivitrol® injection&#xD;
&#xD;
          -  Has used any opioid drug within 10 days prior to treatment&#xD;
&#xD;
          -  Has a condition, disease state, previous medical history, or observed abnormalities&#xD;
             (including physical examination, laboratory evaluation [e.g., kidney or liver function&#xD;
             test result], or urinalysis finding) at screening that, in the opinion of the&#xD;
             investigator, would preclude safe participation in the study or affect the ability of&#xD;
             the subject to adhere to the protocol visit schedule, fulfill visit requirements, or&#xD;
             would interfere with the study assessments, including, but not limited to, the&#xD;
             following:&#xD;
&#xD;
               -  Uncontrolled hypertension, uncontrolled diabetes, renal disease/impairment,&#xD;
                  stroke, seizures or neurological disorder, cardiovascular (eg, endocarditis),&#xD;
                  neoplastic disease&#xD;
&#xD;
               -  Chronic pain condition requiring ongoing opioid analgesia&#xD;
&#xD;
               -  Aspartate aminotransferase or alanine aminotransferase value ≥3 times the upper&#xD;
                  limit of normal&#xD;
&#xD;
               -  Any contraindicated medical condition per the approved labeling for naltrexone&#xD;
&#xD;
          -  Has had a DSM-5 diagnosis within the past 12 months of other psychiatric conditions or&#xD;
             disorders that, in the investigator's opinion, could interfere with participation in&#xD;
             the study&#xD;
&#xD;
          -  Is currently physiologically dependent on any psychoactive substance (except caffeine,&#xD;
             or tobacco) requiring medical intervention for detoxification&#xD;
&#xD;
          -  Has a history of hypersensitivity or adverse reaction to naltrexone, or naloxone&#xD;
&#xD;
          -  Has had significant suicidal ideation or behavior within the past year, as assessed&#xD;
             with the Patient Health Questionnaire (PHQ-9)&#xD;
&#xD;
               -  Note about exclusion criteria: If, after joining the study, a subject has a&#xD;
                  positive drug test, becomes pregnant, or acquires another exclusion condition&#xD;
                  that would have prevented him/her from joining the study, he or she may remain in&#xD;
                  the study but will not be permitted to receive Vivitrol®. Study staff will&#xD;
                  continue to gather interview data and administrative data on any enrolled,&#xD;
                  willing subjects.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Allison G Robertson, PhD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Psychiatry &amp; Behavioral Sciences, Duke University School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fellowship Health Resources (FHR)</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.Vivitrol.com/Content/pdf/prescribing_info.pdf</url>
    <description>Vivitrol prescribing information</description>
  </link>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>November 28, 2016</study_first_submitted>
  <study_first_submitted_qc>November 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 1, 2016</study_first_posted>
  <results_first_submitted>May 26, 2020</results_first_submitted>
  <results_first_submitted_qc>June 12, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">June 16, 2020</results_first_posted>
  <last_update_submitted>June 12, 2020</last_update_submitted>
  <last_update_submitted_qc>June 12, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Medication-assisted treatment</keyword>
  <keyword>Drug Court</keyword>
  <keyword>Pilot study</keyword>
  <keyword>Opioid dependence</keyword>
  <keyword>Criminal justice</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Opioid-Related Disorders</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>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>April 14, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/17/NCT02978417/Prot_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Community treatment provider Fellowship Health Resources (FHR) prescreened 19 people as eligible. Two declined to participate and 3 were terminated from court and lost eligibility, leaving 14 potential subjects.</recruitment_details>
      <pre_assignment_details>Fourteen subjects consented to be in the study and completed a baseline interview. Four were terminated from court thereby losing eligibility, so they were not randomized.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Vivitrol</title>
          <description>All drug court clients in the pilot RCT will receive standard psychosocial treatment for opioid dependence from FHR as part of their drug court program participation. Participants randomized to Vivitrol® will receive standard treatment along with monthly Vivitrol® injections administered by study staff at outpatient visits. Vivitrol® is an extended-release injectable suspension containing 380 mg of naltrexone in a microsphere formulation and 4 mL diluent. The recommended dose of Vivitrol® is 380 mg delivered intramuscularly every 4 weeks or once a month. The injection should be administered by a healthcare provider as an intramuscular (IM) gluteal injection, alternating buttocks for each subsequent injection (see Links section of PRS for more information about Vivitrol).&#xD;
Naltrexone for extended-release injectable suspension: Opioid-dependent Drug Court clients enrolled in the study will receive monthly injections of Vivitrol for up to 12</description>
        </group>
        <group group_id="P2">
          <title>Oral Naltrexone</title>
          <description>Subjects randomized to oral naltrexone in addition to standard psychosocial treatment for opioid dependence from FHR as part of their drug court program participation. Oral naltrexone is the daily tablet formulation naltrexone that carries the same risks and benefits as the long-acting injectable formulation (Vivitrol®), except it does not have any of the risks related to injection (discomfort, potential for infection). Oral naltrexone is administered and provided by FHR to interested and eligible clients as part of the range of their usual care services.&#xD;
Oral naltrexone: Opioid-dependent Drug Court clients enrolled in the study will receive prescriptions for oral naltrexone for up to 12 months if they continue to be medically eligible and willing.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Vivitrol</title>
          <description>All drug court clients in the pilot RCT will receive standard psychosocial treatment for opioid dependence from FHR as part of their drug court program participation. Participants randomized to Vivitrol® will receive standard treatment along with monthly Vivitrol® injections administered by study staff at outpatient visits. Vivitrol® is an extended-release injectable suspension containing 380 mg of naltrexone in a microsphere formulation and 4 mL diluent. The recommended dose of Vivitrol® is 380 mg delivered intramuscularly every 4 weeks or once a month. The injection should be administered by a healthcare provider as an intramuscular (IM) gluteal injection, alternating buttocks for each subsequent injection (see Links section of PRS for more information about Vivitrol).&#xD;
Naltrexone for extended-release injectable suspension: Opioid-dependent Drug Court clients enrolled in the study will receive monthly injections of Vivitrol for up to 12</description>
        </group>
        <group group_id="B2">
          <title>Oral Naltrexone</title>
          <description>Subjects randomized to oral naltrexone in addition to standard psychosocial treatment for opioid dependence from FHR as part of their drug court program participation. Oral naltrexone is the daily tablet formulation naltrexone that carries the same risks and benefits as the long-acting injectable formulation (Vivitrol®), except it does not have any of the risks related to injection (discomfort, potential for infection). Oral naltrexone is administered and provided by FHR to interested and eligible clients as part of the range of their usual care services.&#xD;
Oral naltrexone: Opioid-dependent Drug Court clients enrolled in the study will receive prescriptions for oral naltrexone for up to 12 months if they continue to be medically eligible and willing.</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="5"/>
            <count group_id="B2" value="5"/>
            <count group_id="B3" value="10"/>
          </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="36.2" spread="9.4"/>
                    <measurement group_id="B2" value="37.4" spread="13.4"/>
                    <measurement group_id="B3" value="36.8" spread="10.9"/>
                  </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="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="7"/>
                  </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="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="9"/>
                  </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="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="8"/>
                  </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>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With New Arrests</title>
        <description>Any new arrests during the 12-month study period. This information will be collected from administrative records.</description>
        <time_frame>12 months</time_frame>
        <population>Due to the nature of this pilot phase study, all statistical analyses are considered exploratory.</population>
        <group_list>
          <group group_id="O1">
            <title>Vivitrol</title>
            <description>All drug court clients in the pilot RCT will receive standard psychosocial treatment for opioid dependence from FHR as part of their drug court program participation. Participants randomized to Vivitrol® will receive standard treatment along with monthly Vivitrol® injections administered by study staff at outpatient visits. Vivitrol® is an extended-release injectable suspension containing 380 mg of naltrexone in a microsphere formulation and 4 mL diluent. The recommended dose of Vivitrol® is 380 mg delivered intramuscularly every 4 weeks or once a month. The injection should be administered by a healthcare provider as an intramuscular (IM) gluteal injection, alternating buttocks for each subsequent injection (see Links section of PRS for more information about Vivitrol).&#xD;
Naltrexone for extended-release injectable suspension: Opioid-dependent Drug Court clients enrolled in the study will receive monthly injections of Vivitrol for up to 12</description>
          </group>
          <group group_id="O2">
            <title>Oral Naltrexone</title>
            <description>Subjects randomized to oral naltrexone in addition to standard psychosocial treatment for opioid dependence from FHR as part of their drug court program participation. Oral naltrexone is the daily tablet formulation naltrexone that carries the same risks and benefits as the long-acting injectable formulation (Vivitrol®), except it does not have any of the risks related to injection (discomfort, potential for infection). Oral naltrexone is administered and provided by FHR to interested and eligible clients as part of the range of their usual care services.&#xD;
Oral naltrexone: Opioid-dependent Drug Court clients enrolled in the study will receive prescriptions for oral naltrexone for up to 12 months if they continue to be medically eligible and willing.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With New Arrests</title>
          <description>Any new arrests during the 12-month study period. This information will be collected from administrative records.</description>
          <population>Due to the nature of this pilot phase study, all statistical analyses are considered exploratory.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With New Incarcerations</title>
        <description>Any new incarceration during the 12-month study period. This information will be collected from administrative records.</description>
        <time_frame>12 months</time_frame>
        <population>Due to the nature of this pilot phase study, all statistical analyses are considered exploratory.</population>
        <group_list>
          <group group_id="O1">
            <title>Vivitrol</title>
            <description>All drug court clients in the pilot RCT will receive standard psychosocial treatment for opioid dependence from FHR as part of their drug court program participation. Participants randomized to Vivitrol® will receive standard treatment along with monthly Vivitrol® injections administered by study staff at outpatient visits. Vivitrol® is an extended-release injectable suspension containing 380 mg of naltrexone in a microsphere formulation and 4 mL diluent. The recommended dose of Vivitrol® is 380 mg delivered intramuscularly every 4 weeks or once a month. The injection should be administered by a healthcare provider as an intramuscular (IM) gluteal injection, alternating buttocks for each subsequent injection (see Links section of PRS for more information about Vivitrol).&#xD;
Naltrexone for extended-release injectable suspension: Opioid-dependent Drug Court clients enrolled in the study will receive monthly injections of Vivitrol for up to 12</description>
          </group>
          <group group_id="O2">
            <title>Oral Naltrexone</title>
            <description>Subjects randomized to oral naltrexone in addition to standard psychosocial treatment for opioid dependence from FHR as part of their drug court program participation. Oral naltrexone is the daily tablet formulation naltrexone that carries the same risks and benefits as the long-acting injectable formulation (Vivitrol®), except it does not have any of the risks related to injection (discomfort, potential for infection). Oral naltrexone is administered and provided by FHR to interested and eligible clients as part of the range of their usual care services.&#xD;
Oral naltrexone: Opioid-dependent Drug Court clients enrolled in the study will receive prescriptions for oral naltrexone for up to 12 months if they continue to be medically eligible and willing.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With New Incarcerations</title>
          <description>Any new incarceration during the 12-month study period. This information will be collected from administrative records.</description>
          <population>Due to the nature of this pilot phase study, all statistical analyses are considered exploratory.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Positive Drug Screens</title>
        <description>Number of times a client had a positive drug screen. This information will be collected from administrative records.</description>
        <time_frame>12 months</time_frame>
        <population>Due to the nature of this pilot phase study, all statistical analyses are considered exploratory.</population>
        <group_list>
          <group group_id="O1">
            <title>Vivitrol</title>
            <description>All drug court clients in the pilot RCT will receive standard psychosocial treatment for opioid dependence from FHR as part of their drug court program participation. Participants randomized to Vivitrol® will receive standard treatment along with monthly Vivitrol® injections administered by study staff at outpatient visits. Vivitrol® is an extended-release injectable suspension containing 380 mg of naltrexone in a microsphere formulation and 4 mL diluent. The recommended dose of Vivitrol® is 380 mg delivered intramuscularly every 4 weeks or once a month. The injection should be administered by a healthcare provider as an intramuscular (IM) gluteal injection, alternating buttocks for each subsequent injection (see Links section of PRS for more information about Vivitrol).&#xD;
Naltrexone for extended-release injectable suspension: Opioid-dependent Drug Court clients enrolled in the study will receive monthly injections of Vivitrol for up to 12</description>
          </group>
          <group group_id="O2">
            <title>Oral Naltrexone</title>
            <description>Subjects randomized to oral naltrexone in addition to standard psychosocial treatment for opioid dependence from FHR as part of their drug court program participation. Oral naltrexone is the daily tablet formulation naltrexone that carries the same risks and benefits as the long-acting injectable formulation (Vivitrol®), except it does not have any of the risks related to injection (discomfort, potential for infection). Oral naltrexone is administered and provided by FHR to interested and eligible clients as part of the range of their usual care services.&#xD;
Oral naltrexone: Opioid-dependent Drug Court clients enrolled in the study will receive prescriptions for oral naltrexone for up to 12 months if they continue to be medically eligible and willing.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Positive Drug Screens</title>
          <description>Number of times a client had a positive drug screen. This information will be collected from administrative records.</description>
          <population>Due to the nature of this pilot phase study, all statistical analyses are considered exploratory.</population>
          <units>positive drug screens</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2" spread="1.87"/>
                    <measurement group_id="O2" value="2.8" spread="2.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Sanctions Imposed by the Court</title>
        <description>Number of sanctions imposed by the court (e.g., brief stays in jail). This information will be collected from administrative records.</description>
        <time_frame>12 months</time_frame>
        <population>Due to the nature of this pilot phase study, all statistical analyses are considered exploratory.</population>
        <group_list>
          <group group_id="O1">
            <title>Vivitrol</title>
            <description>All drug court clients in the pilot RCT will receive standard psychosocial treatment for opioid dependence from FHR as part of their drug court program participation. Participants randomized to Vivitrol® will receive standard treatment along with monthly Vivitrol® injections administered by study staff at outpatient visits. Vivitrol® is an extended-release injectable suspension containing 380 mg of naltrexone in a microsphere formulation and 4 mL diluent. The recommended dose of Vivitrol® is 380 mg delivered intramuscularly every 4 weeks or once a month. The injection should be administered by a healthcare provider as an intramuscular (IM) gluteal injection, alternating buttocks for each subsequent injection (see Links section of PRS for more information about Vivitrol).&#xD;
Naltrexone for extended-release injectable suspension: Opioid-dependent Drug Court clients enrolled in the study will receive monthly injections of Vivitrol for up to 12</description>
          </group>
          <group group_id="O2">
            <title>Oral Naltrexone</title>
            <description>Subjects randomized to oral naltrexone in addition to standard psychosocial treatment for opioid dependence from FHR as part of their drug court program participation. Oral naltrexone is the daily tablet formulation naltrexone that carries the same risks and benefits as the long-acting injectable formulation (Vivitrol®), except it does not have any of the risks related to injection (discomfort, potential for infection). Oral naltrexone is administered and provided by FHR to interested and eligible clients as part of the range of their usual care services.&#xD;
Oral naltrexone: Opioid-dependent Drug Court clients enrolled in the study will receive prescriptions for oral naltrexone for up to 12 months if they continue to be medically eligible and willing.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Sanctions Imposed by the Court</title>
          <description>Number of sanctions imposed by the court (e.g., brief stays in jail). This information will be collected from administrative records.</description>
          <population>Due to the nature of this pilot phase study, all statistical analyses are considered exploratory.</population>
          <units>sanctions</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.8" spread="1.30"/>
                    <measurement group_id="O2" value="3.6" spread="3.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Missed Court Appointments</title>
        <description>Number of missed court appointments during the 12-month study period. This information will be collected from administrative records.</description>
        <time_frame>12 months</time_frame>
        <population>Due to the nature of this pilot phase study, all statistical analyses are considered exploratory.</population>
        <group_list>
          <group group_id="O1">
            <title>Vivitrol</title>
            <description>All drug court clients in the pilot RCT will receive standard psychosocial treatment for opioid dependence from FHR as part of their drug court program participation. Participants randomized to Vivitrol® will receive standard treatment along with monthly Vivitrol® injections administered by study staff at outpatient visits. Vivitrol® is an extended-release injectable suspension containing 380 mg of naltrexone in a microsphere formulation and 4 mL diluent. The recommended dose of Vivitrol® is 380 mg delivered intramuscularly every 4 weeks or once a month. The injection should be administered by a healthcare provider as an intramuscular (IM) gluteal injection, alternating buttocks for each subsequent injection (see Links section of PRS for more information about Vivitrol).&#xD;
Naltrexone for extended-release injectable suspension: Opioid-dependent Drug Court clients enrolled in the study will receive monthly injections of Vivitrol for up to 12</description>
          </group>
          <group group_id="O2">
            <title>Oral Naltrexone</title>
            <description>Subjects randomized to oral naltrexone in addition to standard psychosocial treatment for opioid dependence from FHR as part of their drug court program participation. Oral naltrexone is the daily tablet formulation naltrexone that carries the same risks and benefits as the long-acting injectable formulation (Vivitrol®), except it does not have any of the risks related to injection (discomfort, potential for infection). Oral naltrexone is administered and provided by FHR to interested and eligible clients as part of the range of their usual care services.&#xD;
Oral naltrexone: Opioid-dependent Drug Court clients enrolled in the study will receive prescriptions for oral naltrexone for up to 12 months if they continue to be medically eligible and willing.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Missed Court Appointments</title>
          <description>Number of missed court appointments during the 12-month study period. This information will be collected from administrative records.</description>
          <population>Due to the nature of this pilot phase study, all statistical analyses are considered exploratory.</population>
          <units>missed court appointments</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" spread="0"/>
                    <measurement group_id="O2" value="0" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Vivitrol Participation</title>
        <description>Number of Vivitrol injections from either arm of study. This information will be collected from administrative records.</description>
        <time_frame>12 months</time_frame>
        <population>Some subjects in the oral naltrexone arm received Vivitrol through other means. Due to the nature of this pilot phase study, all statistical analyses are considered exploratory.</population>
        <group_list>
          <group group_id="O1">
            <title>Vivitrol</title>
            <description>All drug court clients in the pilot RCT will receive standard psychosocial treatment for opioid dependence from FHR as part of their drug court program participation. Participants randomized to Vivitrol® will receive standard treatment along with monthly Vivitrol® injections administered by study staff at outpatient visits. Vivitrol® is an extended-release injectable suspension containing 380 mg of naltrexone in a microsphere formulation and 4 mL diluent. The recommended dose of Vivitrol® is 380 mg delivered intramuscularly every 4 weeks or once a month. The injection should be administered by a healthcare provider as an intramuscular (IM) gluteal injection, alternating buttocks for each subsequent injection (see Links section of PRS for more information about Vivitrol).&#xD;
Naltrexone for extended-release injectable suspension: Opioid-dependent Drug Court clients enrolled in the study will receive monthly injections of Vivitrol for up to 12</description>
          </group>
          <group group_id="O2">
            <title>Oral Naltrexone</title>
            <description>Subjects randomized to oral naltrexone in addition to standard psychosocial treatment for opioid dependence from FHR as part of their drug court program participation. Oral naltrexone is the daily tablet formulation naltrexone that carries the same risks and benefits as the long-acting injectable formulation (Vivitrol®), except it does not have any of the risks related to injection (discomfort, potential for infection). Oral naltrexone is administered and provided by FHR to interested and eligible clients as part of the range of their usual care services.&#xD;
Oral naltrexone: Opioid-dependent Drug Court clients enrolled in the study will receive prescriptions for oral naltrexone for up to 12 months if they continue to be medically eligible and willing.</description>
          </group>
        </group_list>
        <measure>
          <title>Vivitrol Participation</title>
          <description>Number of Vivitrol injections from either arm of study. This information will be collected from administrative records.</description>
          <population>Some subjects in the oral naltrexone arm received Vivitrol through other means. Due to the nature of this pilot phase study, all statistical analyses are considered exploratory.</population>
          <units>Vivitrol injections</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.8" spread="4.97"/>
                    <measurement group_id="O2" value="1.4" spread="1.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Treatment Participation (Non-Vivitrol)</title>
        <description>Number of oral naltrexone monthly prescriptions from either arm of study. This information will be collected from administrative records.</description>
        <time_frame>12 months</time_frame>
        <population>Due to the nature of this pilot phase study, all statistical analyses are considered exploratory.</population>
        <group_list>
          <group group_id="O1">
            <title>Vivitrol</title>
            <description>All drug court clients in the pilot RCT will receive standard psychosocial treatment for opioid dependence from FHR as part of their drug court program participation. Participants randomized to Vivitrol® will receive standard treatment along with monthly Vivitrol® injections administered by study staff at outpatient visits. Vivitrol® is an extended-release injectable suspension containing 380 mg of naltrexone in a microsphere formulation and 4 mL diluent. The recommended dose of Vivitrol® is 380 mg delivered intramuscularly every 4 weeks or once a month. The injection should be administered by a healthcare provider as an intramuscular (IM) gluteal injection, alternating buttocks for each subsequent injection (see Links section of PRS for more information about Vivitrol).&#xD;
Naltrexone for extended-release injectable suspension: Opioid-dependent Drug Court clients enrolled in the study will receive monthly injections of Vivitrol for up to 12</description>
          </group>
          <group group_id="O2">
            <title>Oral Naltrexone</title>
            <description>Subjects randomized to oral naltrexone in addition to standard psychosocial treatment for opioid dependence from FHR as part of their drug court program participation. Oral naltrexone is the daily tablet formulation naltrexone that carries the same risks and benefits as the long-acting injectable formulation (Vivitrol®), except it does not have any of the risks related to injection (discomfort, potential for infection). Oral naltrexone is administered and provided by FHR to interested and eligible clients as part of the range of their usual care services.&#xD;
Oral naltrexone: Opioid-dependent Drug Court clients enrolled in the study will receive prescriptions for oral naltrexone for up to 12 months if they continue to be medically eligible and willing.</description>
          </group>
        </group_list>
        <measure>
          <title>Treatment Participation (Non-Vivitrol)</title>
          <description>Number of oral naltrexone monthly prescriptions from either arm of study. This information will be collected from administrative records.</description>
          <population>Due to the nature of this pilot phase study, all statistical analyses are considered exploratory.</population>
          <units>oral naltrexone monthly prescriptions</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2" spread="0.45"/>
                    <measurement group_id="O2" value="1.6" spread="2.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Subjective Functioning: Medical Status</title>
        <description>Subjective assessment of medical status using the Addiction Severity Index (ASI) Lite (a single measure with multiple domains) collected via interviews at baseline and approximately six months.</description>
        <time_frame>Baseline, 6 months</time_frame>
        <population>Data not collected.</population>
        <group_list>
          <group group_id="O1">
            <title>Vivitrol</title>
            <description>All drug court clients in the pilot RCT will receive standard psychosocial treatment for opioid dependence from FHR as part of their drug court program participation. Participants randomized to Vivitrol® will receive standard treatment along with monthly Vivitrol® injections administered by study staff at outpatient visits. Vivitrol® is an extended-release injectable suspension containing 380 mg of naltrexone in a microsphere formulation and 4 mL diluent. The recommended dose of Vivitrol® is 380 mg delivered intramuscularly every 4 weeks or once a month. The injection should be administered by a healthcare provider as an intramuscular (IM) gluteal injection, alternating buttocks for each subsequent injection (see Links section of PRS for more information about Vivitrol).&#xD;
Naltrexone for extended-release injectable suspension: Opioid-dependent Drug Court clients enrolled in the study will receive monthly injections of Vivitrol for up to 12</description>
          </group>
          <group group_id="O2">
            <title>Oral Naltrexone</title>
            <description>Subjects randomized to oral naltrexone in addition to standard psychosocial treatment for opioid dependence from FHR as part of their drug court program participation. Oral naltrexone is the daily tablet formulation naltrexone that carries the same risks and benefits as the long-acting injectable formulation (Vivitrol®), except it does not have any of the risks related to injection (discomfort, potential for infection). Oral naltrexone is administered and provided by FHR to interested and eligible clients as part of the range of their usual care services.&#xD;
Oral naltrexone: Opioid-dependent Drug Court clients enrolled in the study will receive prescriptions for oral naltrexone for up to 12 months if they continue to be medically eligible and willing.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Subjective Functioning: Medical Status</title>
          <description>Subjective assessment of medical status using the Addiction Severity Index (ASI) Lite (a single measure with multiple domains) collected via interviews at baseline and approximately six months.</description>
          <population>Data not collected.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Reported Improvement in Subjective Functioning: Employment/Support Status</title>
        <description>Subjective assessment of employment opportunities collected via interviews at baseline and approximately six months.</description>
        <time_frame>Baseline, 6 months</time_frame>
        <population>Subjects who completed the 6-month assessment. Due to the nature of this pilot phase study, all statistical analyses are considered exploratory.</population>
        <group_list>
          <group group_id="O1">
            <title>Vivitrol</title>
            <description>All drug court clients in the pilot RCT will receive standard psychosocial treatment for opioid dependence from FHR as part of their drug court program participation. Participants randomized to Vivitrol® will receive standard treatment along with monthly Vivitrol® injections administered by study staff at outpatient visits. Vivitrol® is an extended-release injectable suspension containing 380 mg of naltrexone in a microsphere formulation and 4 mL diluent. The recommended dose of Vivitrol® is 380 mg delivered intramuscularly every 4 weeks or once a month. The injection should be administered by a healthcare provider as an intramuscular (IM) gluteal injection, alternating buttocks for each subsequent injection (see Links section of PRS for more information about Vivitrol).&#xD;
Naltrexone for extended-release injectable suspension: Opioid-dependent Drug Court clients enrolled in the study will receive monthly injections of Vivitrol for up to 12</description>
          </group>
          <group group_id="O2">
            <title>Oral Naltrexone</title>
            <description>Subjects randomized to oral naltrexone in addition to standard psychosocial treatment for opioid dependence from FHR as part of their drug court program participation. Oral naltrexone is the daily tablet formulation naltrexone that carries the same risks and benefits as the long-acting injectable formulation (Vivitrol®), except it does not have any of the risks related to injection (discomfort, potential for infection). Oral naltrexone is administered and provided by FHR to interested and eligible clients as part of the range of their usual care services.&#xD;
Oral naltrexone: Opioid-dependent Drug Court clients enrolled in the study will receive prescriptions for oral naltrexone for up to 12 months if they continue to be medically eligible and willing.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Reported Improvement in Subjective Functioning: Employment/Support Status</title>
          <description>Subjective assessment of employment opportunities collected via interviews at baseline and approximately six months.</description>
          <population>Subjects who completed the 6-month assessment. Due to the nature of this pilot phase study, all statistical analyses are considered exploratory.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Reported Improvement in Substance Use</title>
        <description>Subjective assessment of alcohol/drug use in past 30 days collected via interviews at baseline and approximately six months.</description>
        <time_frame>Baseline, 6 months</time_frame>
        <population>Subjects who completed the 6-month assessment. Due to the nature of this pilot phase study, all statistical analyses are considered exploratory.</population>
        <group_list>
          <group group_id="O1">
            <title>Vivitrol</title>
            <description>All drug court clients in the pilot RCT will receive standard psychosocial treatment for opioid dependence from FHR as part of their drug court program participation. Participants randomized to Vivitrol® will receive standard treatment along with monthly Vivitrol® injections administered by study staff at outpatient visits. Vivitrol® is an extended-release injectable suspension containing 380 mg of naltrexone in a microsphere formulation and 4 mL diluent. The recommended dose of Vivitrol® is 380 mg delivered intramuscularly every 4 weeks or once a month. The injection should be administered by a healthcare provider as an intramuscular (IM) gluteal injection, alternating buttocks for each subsequent injection (see Links section of PRS for more information about Vivitrol).&#xD;
Naltrexone for extended-release injectable suspension: Opioid-dependent Drug Court clients enrolled in the study will receive monthly injections of Vivitrol for up to 12</description>
          </group>
          <group group_id="O2">
            <title>Oral Naltrexone</title>
            <description>Subjects randomized to oral naltrexone in addition to standard psychosocial treatment for opioid dependence from FHR as part of their drug court program participation. Oral naltrexone is the daily tablet formulation naltrexone that carries the same risks and benefits as the long-acting injectable formulation (Vivitrol®), except it does not have any of the risks related to injection (discomfort, potential for infection). Oral naltrexone is administered and provided by FHR to interested and eligible clients as part of the range of their usual care services.&#xD;
Oral naltrexone: Opioid-dependent Drug Court clients enrolled in the study will receive prescriptions for oral naltrexone for up to 12 months if they continue to be medically eligible and willing.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Reported Improvement in Substance Use</title>
          <description>Subjective assessment of alcohol/drug use in past 30 days collected via interviews at baseline and approximately six months.</description>
          <population>Subjects who completed the 6-month assessment. Due to the nature of this pilot phase study, all statistical analyses are considered exploratory.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Reported Illegal Behavior</title>
        <description>Subjective assessment of illegal behavior using the question, &quot;Have you done anything that was against the law in the last 30 days?&quot; collected via interviews approximately six months after baseline.</description>
        <time_frame>approximately 6 months</time_frame>
        <population>Subjects who completed the 6-month assessment. Due to the nature of this pilot phase study, all statistical analyses are considered exploratory.</population>
        <group_list>
          <group group_id="O1">
            <title>Vivitrol</title>
            <description>All drug court clients in the pilot RCT will receive standard psychosocial treatment for opioid dependence from FHR as part of their drug court program participation. Participants randomized to Vivitrol® will receive standard treatment along with monthly Vivitrol® injections administered by study staff at outpatient visits. Vivitrol® is an extended-release injectable suspension containing 380 mg of naltrexone in a microsphere formulation and 4 mL diluent. The recommended dose of Vivitrol® is 380 mg delivered intramuscularly every 4 weeks or once a month. The injection should be administered by a healthcare provider as an intramuscular (IM) gluteal injection, alternating buttocks for each subsequent injection (see Links section of PRS for more information about Vivitrol).&#xD;
Naltrexone for extended-release injectable suspension: Opioid-dependent Drug Court clients enrolled in the study will receive monthly injections of Vivitrol for up to 12</description>
          </group>
          <group group_id="O2">
            <title>Oral Naltrexone</title>
            <description>Subjects randomized to oral naltrexone in addition to standard psychosocial treatment for opioid dependence from FHR as part of their drug court program participation. Oral naltrexone is the daily tablet formulation naltrexone that carries the same risks and benefits as the long-acting injectable formulation (Vivitrol®), except it does not have any of the risks related to injection (discomfort, potential for infection). Oral naltrexone is administered and provided by FHR to interested and eligible clients as part of the range of their usual care services.&#xD;
Oral naltrexone: Opioid-dependent Drug Court clients enrolled in the study will receive prescriptions for oral naltrexone for up to 12 months if they continue to be medically eligible and willing.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Reported Illegal Behavior</title>
          <description>Subjective assessment of illegal behavior using the question, &quot;Have you done anything that was against the law in the last 30 days?&quot; collected via interviews approximately six months after baseline.</description>
          <population>Subjects who completed the 6-month assessment. Due to the nature of this pilot phase study, all statistical analyses are considered exploratory.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Reported Improvement in Subjective Functioning: Family/Social Relationships</title>
        <description>Subjective assessment of family and social relationships using a single question about satisfaction with relationships over the past 30 days collected via interviews at baseline and approximately six months.</description>
        <time_frame>Baseline, approximately 6 months</time_frame>
        <population>Subjects who completed the 6-month assessment. Due to the nature of this pilot phase study, all statistical analyses are considered exploratory.</population>
        <group_list>
          <group group_id="O1">
            <title>Vivitrol</title>
            <description>All drug court clients in the pilot RCT will receive standard psychosocial treatment for opioid dependence from FHR as part of their drug court program participation. Participants randomized to Vivitrol® will receive standard treatment along with monthly Vivitrol® injections administered by study staff at outpatient visits. Vivitrol® is an extended-release injectable suspension containing 380 mg of naltrexone in a microsphere formulation and 4 mL diluent. The recommended dose of Vivitrol® is 380 mg delivered intramuscularly every 4 weeks or once a month. The injection should be administered by a healthcare provider as an intramuscular (IM) gluteal injection, alternating buttocks for each subsequent injection (see Links section of PRS for more information about Vivitrol).&#xD;
Naltrexone for extended-release injectable suspension: Opioid-dependent Drug Court clients enrolled in the study will receive monthly injections of Vivitrol for up to 12</description>
          </group>
          <group group_id="O2">
            <title>Oral Naltrexone</title>
            <description>Subjects randomized to oral naltrexone in addition to standard psychosocial treatment for opioid dependence from FHR as part of their drug court program participation. Oral naltrexone is the daily tablet formulation naltrexone that carries the same risks and benefits as the long-acting injectable formulation (Vivitrol®), except it does not have any of the risks related to injection (discomfort, potential for infection). Oral naltrexone is administered and provided by FHR to interested and eligible clients as part of the range of their usual care services.&#xD;
Oral naltrexone: Opioid-dependent Drug Court clients enrolled in the study will receive prescriptions for oral naltrexone for up to 12 months if they continue to be medically eligible and willing.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Reported Improvement in Subjective Functioning: Family/Social Relationships</title>
          <description>Subjective assessment of family and social relationships using a single question about satisfaction with relationships over the past 30 days collected via interviews at baseline and approximately six months.</description>
          <population>Subjects who completed the 6-month assessment. Due to the nature of this pilot phase study, all statistical analyses are considered exploratory.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Subjective Functioning: Psychiatric Status</title>
        <description>Subjective assessment of psychiatric status using the Addiction Severity Index (ASI) Lite (a single measure with multiple domains) collected via interviews at baseline and approximately six months.</description>
        <time_frame>Baseline, approximately 6 months</time_frame>
        <population>Data not collected.</population>
        <group_list>
          <group group_id="O1">
            <title>Vivitrol</title>
            <description>All drug court clients in the pilot RCT will receive standard psychosocial treatment for opioid dependence from FHR as part of their drug court program participation. Participants randomized to Vivitrol® will receive standard treatment along with monthly Vivitrol® injections administered by study staff at outpatient visits. Vivitrol® is an extended-release injectable suspension containing 380 mg of naltrexone in a microsphere formulation and 4 mL diluent. The recommended dose of Vivitrol® is 380 mg delivered intramuscularly every 4 weeks or once a month. The injection should be administered by a healthcare provider as an intramuscular (IM) gluteal injection, alternating buttocks for each subsequent injection (see Links section of PRS for more information about Vivitrol).&#xD;
Naltrexone for extended-release injectable suspension: Opioid-dependent Drug Court clients enrolled in the study will receive monthly injections of Vivitrol for up to 12</description>
          </group>
          <group group_id="O2">
            <title>Oral Naltrexone</title>
            <description>Subjects randomized to oral naltrexone in addition to standard psychosocial treatment for opioid dependence from FHR as part of their drug court program participation. Oral naltrexone is the daily tablet formulation naltrexone that carries the same risks and benefits as the long-acting injectable formulation (Vivitrol®), except it does not have any of the risks related to injection (discomfort, potential for infection). Oral naltrexone is administered and provided by FHR to interested and eligible clients as part of the range of their usual care services.&#xD;
Oral naltrexone: Opioid-dependent Drug Court clients enrolled in the study will receive prescriptions for oral naltrexone for up to 12 months if they continue to be medically eligible and willing.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Subjective Functioning: Psychiatric Status</title>
          <description>Subjective assessment of psychiatric status using the Addiction Severity Index (ASI) Lite (a single measure with multiple domains) collected via interviews at baseline and approximately six months.</description>
          <population>Data not collected.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Treatment Satisfaction Score</title>
        <description>Reported as average of 12-item treatment satisfaction score at approximately six months. A score of 5 indicates strong agreement with positive statements about treatment satisfaction; a score of 0 indicates strong disagreement.</description>
        <time_frame>Approximately 6 months</time_frame>
        <population>Subjects who completed the 6-month assessment. Due to the nature of this pilot phase study, all statistical analyses are considered exploratory.</population>
        <group_list>
          <group group_id="O1">
            <title>Vivitrol</title>
            <description>All drug court clients in the pilot RCT will receive standard psychosocial treatment for opioid dependence from FHR as part of their drug court program participation. Participants randomized to Vivitrol® will receive standard treatment along with monthly Vivitrol® injections administered by study staff at outpatient visits. Vivitrol® is an extended-release injectable suspension containing 380 mg of naltrexone in a microsphere formulation and 4 mL diluent. The recommended dose of Vivitrol® is 380 mg delivered intramuscularly every 4 weeks or once a month. The injection should be administered by a healthcare provider as an intramuscular (IM) gluteal injection, alternating buttocks for each subsequent injection (see Links section of PRS for more information about Vivitrol).&#xD;
Naltrexone for extended-release injectable suspension: Opioid-dependent Drug Court clients enrolled in the study will receive monthly injections of Vivitrol for up to 12</description>
          </group>
          <group group_id="O2">
            <title>Oral Naltrexone</title>
            <description>Subjects randomized to oral naltrexone in addition to standard psychosocial treatment for opioid dependence from FHR as part of their drug court program participation. Oral naltrexone is the daily tablet formulation naltrexone that carries the same risks and benefits as the long-acting injectable formulation (Vivitrol®), except it does not have any of the risks related to injection (discomfort, potential for infection). Oral naltrexone is administered and provided by FHR to interested and eligible clients as part of the range of their usual care services.&#xD;
Oral naltrexone: Opioid-dependent Drug Court clients enrolled in the study will receive prescriptions for oral naltrexone for up to 12 months if they continue to be medically eligible and willing.</description>
          </group>
        </group_list>
        <measure>
          <title>Treatment Satisfaction Score</title>
          <description>Reported as average of 12-item treatment satisfaction score at approximately six months. A score of 5 indicates strong agreement with positive statements about treatment satisfaction; a score of 0 indicates strong disagreement.</description>
          <population>Subjects who completed the 6-month assessment. Due to the nature of this pilot phase study, all statistical analyses are considered exploratory.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.53" spread="0.75"/>
                    <measurement group_id="O2" value="4.83" spread="0.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Medication-assisted Treatment (MAT) Attitudes</title>
        <description>Change in MAT attitudes from baseline to follow-up. The average score of 4 questions about MAT for substance use disorder were calculated at baseline and follow-up, and the average score at baseline was subtracted from the average score at follow-up. The averages are based on questions for which a score of 5 indicates strong agreement with statements about MAT; a score of 1 indicates strong disagreement with such statements.</description>
        <time_frame>Baseline, approximately 6 months</time_frame>
        <population>Subjects who completed the 6-month assessment. Due to the nature of this pilot phase study, all statistical analyses are considered exploratory.</population>
        <group_list>
          <group group_id="O1">
            <title>Vivitrol</title>
            <description>All drug court clients in the pilot RCT will receive standard psychosocial treatment for opioid dependence from FHR as part of their drug court program participation. Participants randomized to Vivitrol® will receive standard treatment along with monthly Vivitrol® injections administered by study staff at outpatient visits. Vivitrol® is an extended-release injectable suspension containing 380 mg of naltrexone in a microsphere formulation and 4 mL diluent. The recommended dose of Vivitrol® is 380 mg delivered intramuscularly every 4 weeks or once a month. The injection should be administered by a healthcare provider as an intramuscular (IM) gluteal injection, alternating buttocks for each subsequent injection (see Links section of PRS for more information about Vivitrol).&#xD;
Naltrexone for extended-release injectable suspension: Opioid-dependent Drug Court clients enrolled in the study will receive monthly injections of Vivitrol for up to 12</description>
          </group>
          <group group_id="O2">
            <title>Oral Naltrexone</title>
            <description>Subjects randomized to oral naltrexone in addition to standard psychosocial treatment for opioid dependence from FHR as part of their drug court program participation. Oral naltrexone is the daily tablet formulation naltrexone that carries the same risks and benefits as the long-acting injectable formulation (Vivitrol®), except it does not have any of the risks related to injection (discomfort, potential for infection). Oral naltrexone is administered and provided by FHR to interested and eligible clients as part of the range of their usual care services.&#xD;
Oral naltrexone: Opioid-dependent Drug Court clients enrolled in the study will receive prescriptions for oral naltrexone for up to 12 months if they continue to be medically eligible and willing.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Medication-assisted Treatment (MAT) Attitudes</title>
          <description>Change in MAT attitudes from baseline to follow-up. The average score of 4 questions about MAT for substance use disorder were calculated at baseline and follow-up, and the average score at baseline was subtracted from the average score at follow-up. The averages are based on questions for which a score of 5 indicates strong agreement with statements about MAT; a score of 1 indicates strong disagreement with such statements.</description>
          <population>Subjects who completed the 6-month assessment. Due to the nature of this pilot phase study, all statistical analyses are considered exploratory.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.11" spread="0.59"/>
                    <measurement group_id="O2" value="0.08" spread="0.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Approximately 6 months.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Vivitrol</title>
          <description>All drug court clients in the pilot RCT will receive standard psychosocial treatment for opioid dependence from FHR as part of their drug court program participation. Participants randomized to Vivitrol® will receive standard treatment along with monthly Vivitrol® injections administered by study staff at outpatient visits. Vivitrol® is an extended-release injectable suspension containing 380 mg of naltrexone in a microsphere formulation and 4 mL diluent. The recommended dose of Vivitrol® is 380 mg delivered intramuscularly every 4 weeks or once a month. The injection should be administered by a healthcare provider as an intramuscular (IM) gluteal injection, alternating buttocks for each subsequent injection (see Links section of PRS for more information about Vivitrol).&#xD;
Naltrexone for extended-release injectable suspension: Opioid-dependent Drug Court clients enrolled in the study will receive monthly injections of Vivitrol for up to 12</description>
        </group>
        <group group_id="E2">
          <title>Oral Naltrexone</title>
          <description>Subjects randomized to oral naltrexone in addition to standard psychosocial treatment for opioid dependence from FHR as part of their drug court program participation. Oral naltrexone is the daily tablet formulation naltrexone that carries the same risks and benefits as the long-acting injectable formulation (Vivitrol®), except it does not have any of the risks related to injection (discomfort, potential for infection). Oral naltrexone is administered and provided by FHR to interested and eligible clients as part of the range of their usual care services.&#xD;
Oral naltrexone: Opioid-dependent Drug Court clients enrolled in the study will receive prescriptions for oral naltrexone for up to 12 months if they continue to be medically eligible and willing.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Drug overdose (unrelated)</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Social circumstances</title>
            <event_list>
              <event>
                <sub_title>Incarceration &gt;5 days</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="5"/>
              </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>
    <point_of_contact>
      <name_or_title>Michele Easter, Ph.D.</name_or_title>
      <organization>Duke University</organization>
      <phone>919-385-0862</phone>
      <email>michele.easter@duke.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/NCT02978417
org study id: Pro00074507
secondary id: 69665
nct id: NCT02978417
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
In preparation for a large-scale randomized controlled trial (RCT) of Vivitrol® effectiveness
      in drug courts, investigators propose a feasibility study in the Wake County, North Carolina
      drug court, where an estimated 50% of clients are opioid dependent.

      Aim 1: Pilot RCT. Pilot-test the delivery of Vivitrol® treatment for 10-20 interested and
      eligible clients of the Wake County Drug Court.
Aim 1. Pilot RCT. The pilot delivery of Vivitrol® in the Wake County Drug Court will be
      carried out with 20-40 eligible drug court clients under treatment by Fellowship Health
      Resources, Inc. (FHR), the community behavioral health treatment agency that is the
      contracted treatment provider for the Wake County Drug Court. Participants will be randomized
      in equal number to receive Vivitrol® plus treatment as usual (TAU) or TAU only. TAU for drug
      court clients receiving services at FHR includes psychosocial treatment such as individual or
      group therapy, and sometimes also oral naltrexone for clients who are medically eligible and
      interested in taking the medication, the cost of which is covered by the agency for uninsured
      clients. (FHR currently administers Vivitrol® for a small number of interested agency clients
      with health insurance that covers the medication; the vast majority of their drug court
      clients are uninsured and so have no real access to the extended-release formulation due to
      its high cost.) Vivitrol® is an FDA-approved extended-release injectable form of naltrexone.
      Naltrexone is also available in oral, but not extended release, form. Naltrexone is an opioid
      antagonist that "blocks" opioid receptors in the brain to stop pleasurable feelings
      associated with taking opioids. Potentially eligible subjects will be drug court-referred FHR
      clients willing and eligible to take Vivitrol®, and willing to be randomly assigned to
      Vivitrol® or TAU. Potential subjects already under treatment with oral naltrexone at FHR
      would be eligible to enter the study if willing to switch to injectable Vivitrol® if randomly
      assigned. Study subjects who are randomized to Vivitrol® would receive a once-monthly
      injection of Vivitrol® for 12 months, or less if they decide to stop receiving Vivitrol® or
      to drop out of the study. Those randomized to TAU would continue with treatment as before,
      which could including (1) staying on oral naltrexone if already on it, (2) considering
      starting oral naltrexone, if interested, or (3) continuing with psychosocial treatment only.
      The Vivitrol® will be administered by study medical personnel at FHR. Randomization to the
      Vivitrol® arm would add urine pregnancy testing to FHR's existing Vivitrol® medical
      evaluation protocol and consent process, which currently screens for pregnancy without
      requiring a urine test. A urine pregnancy test will be administered once per month for female
      study participants of child-bearing age who are in the Vivitrol® group. All drug court
      clients, including study participants in both study groups, have urine drug tests at least
      once per week as part of program participation.

      In addition to participating in Vivitrol® and psychosocial treatment, pilot RCT participants
      will provide consent for FHR and the drug court to share information with the study team
      about their demographic and clinical characteristics, treatment participation (e.g.,
      outpatient group therapy), and court-related events (e.g., type of conviction that led to
      their drug court participation, missed drug court appointments, sanctions for program
      violations, and the results of drug screens).

      Participants will also provide two face-to-face interviews at baseline and 6 months after
      baseline, about their interest and experience in Vivitrol® and/or other medication-assisted
      treatment (MAT), other treatment preferences, level of functioning, quality of life, and
      engagement in employment or education.

      Outcome measures include treatment participation, compliance with drug court conditions,
      arrests and incarcerations, treatment satisfaction, and self-reported subjective measures of
      functioning and quality of life.

      If a participant chooses not to participate in the study at any time, it will not affect
      his/her relationship with the court, FHR, right to health care, or participation in the study
      interview data collection. Site staff will follow participants for the purposes of collecting
      research and safety information. Investigators discontinue Vivitrol® or oral naltrexone in
      circumstances such as: adverse reactions to the medication; a change in medical status that
      makes it unsafe for a participant to continue receiving the medication, including pregnancy;
      or a participant becoming ill during the study. Participants who discontinue Vivitrol® or
      oral naltrexone for any reason may continue to participate in interviews for the study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Number of Participants With New Arrests
time frame: 12 months
description: Any new arrests during the 12-month study period. This information will be collected from administrative records.
measure: Number of Participants With New Incarcerations
time frame: 12 months
description: Any new incarceration during the 12-month study period. This information will be collected from administrative records.
measure: Number of Positive Drug Screens
time frame: 12 months
description: Number of times a client had a positive drug screen. This information will be collected from administrative records.
measure: Number of Sanctions Imposed by the Court
time frame: 12 months
description: Number of sanctions imposed by the court (e.g., brief stays in jail). This information will be collected from administrative records.
measure: Number of Missed Court Appointments
time frame: 12 months
description: Number of missed court appointments during the 12-month study period. This information will be collected from administrative records.
measure: Vivitrol Participation
time frame: 12 months
description: Number of Vivitrol injections from either arm of study. This information will be collected from administrative records.
measure: Treatment Participation (Non-Vivitrol)
time frame: 12 months
description: Number of oral naltrexone monthly prescriptions from either arm of study. This information will be collected from administrative records.
measure: Change in Subjective Functioning: Medical Status
time frame: Baseline, 6 months
description: Subjective assessment of medical status using the Addiction Severity Index (ASI) Lite (a single measure with multiple domains) collected via interviews at baseline and approximately six months.
measure: Number of Participants Who Reported Improvement in Subjective Functioning: Employment/Support Status
time frame: Baseline, 6 months
description: Subjective assessment of employment opportunities collected via interviews at baseline and approximately six months.
measure: Number of Participants Who Reported Improvement in Substance Use
time frame: Baseline, 6 months
description: Subjective assessment of alcohol/drug use in past 30 days collected via interviews at baseline and approximately six months.
measure: Number of Participants Who Reported Illegal Behavior
time frame: approximately 6 months
description: Subjective assessment of illegal behavior using the question, "Have you done anything that was against the law in the last 30 days?" collected via interviews approximately six months after baseline.
measure: Number of Participants Who Reported Improvement in Subjective Functioning: Family/Social Relationships
time frame: Baseline, approximately 6 months
description: Subjective assessment of family and social relationships using a single question about satisfaction with relationships over the past 30 days collected via interviews at baseline and approximately six months.
measure: Change in Subjective Functioning: Psychiatric Status
time frame: Baseline, approximately 6 months
description: Subjective assessment of psychiatric status using the Addiction Severity Index (ASI) Lite (a single measure with multiple domains) collected via interviews at baseline and approximately six months.
measure: Treatment Satisfaction Score
time frame: Approximately 6 months
description: Reported as average of 12-item treatment satisfaction score at approximately six months. A score of 5 indicates strong agreement with positive statements about treatment satisfaction; a score of 0 indicates strong disagreement.
measure: Change in Medication-assisted Treatment (MAT) Attitudes
time frame: Baseline, approximately 6 months
description: Change in MAT attitudes from baseline to follow-up. The average score of 4 questions about MAT for substance use disorder were calculated at baseline and follow-up, and the average score at baseline was subtracted from the average score at follow-up. The averages are based on questions for which a score of 5 indicates strong agreement with statements about MAT; a score of 1 indicates strong disagreement with such statements.
arm group label: Vivitrol
arm group type: Active Comparator
description: All drug court clients in the pilot RCT will receive standard psychosocial treatment for opioid dependence from FHR as part of their drug court program participation. Participants randomized to Vivitrol® will receive standard treatment along with monthly Vivitrol® injections administered by study staff at outpatient visits. Vivitrol® is naltrexone for extended-release injectable suspension. It is an injectable suspension containing 380 mg of naltrexone in a microsphere formulation and 4 mL diluent. The recommended dose of Vivitrol® is 380 mg delivered intramuscularly every 4 weeks or once a month. The injection should be administered by a healthcare provider as an intramuscular (IM) gluteal injection, alternating buttocks for each subsequent injection (see Links section of PRS for more information about Vivitrol).
arm group label: Oral naltrexone
arm group type: Active Comparator
description: Subjects randomized to oral naltrexone in addition to standard psychosocial treatment for opioid dependence from FHR as part of their drug court program participation. Oral naltrexone is the daily tablet formulation naltrexone that carries the same risks and benefits as the long-acting injectable formulation (Vivitrol®), except it does not have any of the risks related to injection (discomfort, potential for infection). Oral naltrexone is administered and provided by FHR to interested and eligible clients as part of the range of their usual care services.
intervention type: Drug
intervention name: Naltrexone for extended-release injectable suspension
description: Opioid-dependent Drug Court clients enrolled in the study will receive monthly injections of Vivitrol for up to 12 months if they continue to be medically eligible and willing.
arm group label: Vivitrol
other name: Vivitrol
intervention type: Drug
intervention name: Oral naltrexone
description: Opioid-dependent Drug Court clients enrolled in the study will receive prescriptions for oral naltrexone for up to 12 months if they continue to be medically eligible and willing.
arm group label: Oral naltrexone
other name: Revia
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Allison G Robertson, PhD, MPH
role: Principal Investigator
affiliation: Department of Psychiatry & Behavioral Sciences, Duke University School of Medicine
facility: 
country: United States
url: http://www.Vivitrol.com/Content/pdf/prescribing_info.pdf
description: Vivitrol prescribing information
responsible party type: Sponsor
mesh term: Opioid-Related Disorders
mesh term: Naltrexone
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 