<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/NCT03789214</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00198426</org_study_id>
    <secondary_id>UG3DA048734</secondary_id>
    <nct_id>NCT03789214</nct_id>
  </id_info>
  <brief_title>Medical Management of Sleep Disturbance During Opioid Tapering</brief_title>
  <official_title>Medical Management of Sleep Disturbance During Opioid Tapering</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Drug Abuse (NIDA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Johns Hopkins 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>
      This study will evaluate whether a dual orexin-receptor antagonist approved by the FDA for&#xD;
      sleep disturbance, suvorexant (SUVO; Belsomra), will increase total sleep time in patients&#xD;
      with opioid use disorder (OUD) undergoing supervised withdrawal. This study is designed as a&#xD;
      dose-finding study of SUVO compared to placebo. Briefly, OUD patients seeking supervised&#xD;
      withdrawal will be admitted into a clinical research unit and stabilized onto buprenorphine&#xD;
      for three days before being randomly assigned to study condition. All participants will then&#xD;
      undergo a routine four-day buprenorphine taper, followed by a four-day post-taper phase.&#xD;
      Participants will be randomized to receive either placebo, Low Dose SUVO, or High Dose SUVO&#xD;
      and the investigators hypothesize that one or both doses of SUVO will improve total sleep&#xD;
      time relative to placebo. Patients will attend a single follow-up session, 5-10 days&#xD;
      following discharge.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2019</start_date>
  <completion_date type="Actual">June 10, 2021</completion_date>
  <primary_completion_date type="Actual">June 10, 2021</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Abuse Liability as Assessed by Visual Analogue Scale</measure>
    <time_frame>4 nights</time_frame>
    <description>Area-under-the-curve of self-reported feelings of drug &quot;High&quot; on the morning after study drug administration, measured each morning on a 0-100 point visual analogue scale of the question &quot;Last night, did you feel HIGH?&quot;. A score of &quot;0&quot; indicates no abuse liability and a score of 100 indicates extreme abuse liability. This will be assessed over four nights during an opioid taper.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Total Sleep Time During Buprenorphine Taper</measure>
    <time_frame>Four nights during a buprenorphine taper</time_frame>
    <description>Area-under-the-curve scores of total number of minutes slept per night as measured by a 3-lead wireless electroencephalography and wrist worn actigraphy.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Total Sleep Time During Post-taper</measure>
    <time_frame>Four nights following buprenorphine discontinuation</time_frame>
    <description>Area-under-the-curve scores of total number of minutes slept per night as measured by a 3-lead wireless electroencephalography and wrist worn actigraphy.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Subjective Opiate Withdrawal Scale During Buprenorphine Taper</measure>
    <time_frame>Three days during a buprenorphine taper</time_frame>
    <description>Area-under-the-curve of peak daily scores on the Subjective Opiate Withdrawal Scale (SOWS) (a 16-item self-reported scale that measures individual opioid withdrawal symptoms using a 0-4 Likert scale; total range of SOWS is 0-64; lower scores indicate mild opioid withdrawal relative to higher scores which indicate more severe opioid withdrawal).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Subjective Opiate Withdrawal Scale During Post-taper</measure>
    <time_frame>Three days following buprenorphine discontinuation</time_frame>
    <description>Area-under-the-curve of peak daily scores on the Subjective Opiate Withdrawal Scale (SOWS) (a 16-item self-reported scale that measures individual opioid withdrawal symptoms using a 0-4 Likert scale; total range of SOWS is 0-64; lower scores indicate mild opioid withdrawal relative to higher scores which indicate more severe opioid withdrawal).</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Opioid Dependence</condition>
  <condition>Opioid Withdrawal</condition>
  <condition>Sleep Disturbance</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo sleep medication (Placebo oral capsule)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low Dose Suvorexant</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Low dose sleep medication</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High Dose Suvorexant</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>High dose sleep medication</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo oral capsule</intervention_name>
    <description>Placebo Sleep Medication</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Low Dose Suvorexant</intervention_name>
    <description>Low Dose Suvorexant</description>
    <arm_group_label>Low Dose Suvorexant</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>High Dose Suvorexant</intervention_name>
    <description>High Dose Suvorexant</description>
    <arm_group_label>High Dose Suvorexant</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged 18 years old and above&#xD;
&#xD;
          -  Meets Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria for OUD&#xD;
             with evidence of physical dependence on opioids, and seeking treatment to stop using&#xD;
             illicit opioids.&#xD;
&#xD;
          -  Provides a urine sample that tests positive for opioids.&#xD;
&#xD;
          -  Willing to comply with the study protocol.&#xD;
&#xD;
          -  Have no clinically significant chronic medical or surgical disorders or conditions&#xD;
             that are judged by the investigators to prevent participation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Seeking or currently enrolled in methadone or buprenorphine maintenance treatment for&#xD;
             OUD&#xD;
&#xD;
          -  Pregnant or breast feeding&#xD;
&#xD;
          -  Have evidence of physical dependence on alcohol or benzodiazepines that requires&#xD;
             medical detoxification&#xD;
&#xD;
          -  Have a known allergy to the study medications&#xD;
&#xD;
          -  Past 30-day prescribed use of suvorexant or benzodiazepines for the indication of&#xD;
             insomnia&#xD;
&#xD;
          -  Current use of a Selective Serotonin Reuptake Inhibitor (SSRI) or Monoamine oxidase&#xD;
             (MAO) inhibitor for depression or insomnia, or other medications that are&#xD;
             contraindicated with suvorexant&#xD;
&#xD;
          -  Current narcolepsy, restless leg syndrome or sleep paralysis&#xD;
&#xD;
          -  High risk for current sleep apnea&#xD;
&#xD;
          -  Current major depressive disorder&#xD;
&#xD;
          -  Past year suicidal behavior&#xD;
&#xD;
          -  Severe hepatic or renal impairment&#xD;
&#xD;
               -  Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) &gt;3x ULN&#xD;
&#xD;
               -  Total bilirubin &gt;2x Upper Limit of Normal (ULN)&#xD;
&#xD;
               -  Creatinine &gt;1.5x ULN&#xD;
&#xD;
          -  Have circumstances that would interfere with study participation (e.g., impending&#xD;
             jail)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Self-reported male or female</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andrew S Huhn, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Johns Hopkins Bayview Medical Center</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>December 26, 2018</study_first_submitted>
  <study_first_submitted_qc>December 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 28, 2018</study_first_posted>
  <results_first_submitted>May 18, 2022</results_first_submitted>
  <results_first_submitted_qc>July 12, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">August 8, 2022</results_first_posted>
  <last_update_submitted>July 12, 2022</last_update_submitted>
  <last_update_submitted_qc>July 12, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 8, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dyssomnias</mesh_term>
    <mesh_term>Parasomnias</mesh_term>
    <mesh_term>Opioid-Related Disorders</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Suvorexant</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 4, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/14/NCT03789214/Prot_SAP_002.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>June 1, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/14/NCT03789214/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>90 individuals were consented and screened (35 did not meet eligibility criteria), 55 were scheduled for admission (7 did not present for admission), 48 were admitted for buprenorphine induction (2 were found to be ineligible at this stage and another 6 left prior to randomization), 40 were randomized (1 left before receiving study drug and 1 was excluded because of uncontrolled precipitated withdrawal), and 38 were included in the analyses of study outcomes.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Placebo</title>
          <description>Placebo sleep medication (Placebo oral capsule)&#xD;
Placebo oral capsule: Placebo Sleep Medication</description>
        </group>
        <group group_id="P2">
          <title>Low Dose Suvorexant</title>
          <description>Low dose sleep medication&#xD;
Low Dose Suvorexant: Low Dose Suvorexant</description>
        </group>
        <group group_id="P3">
          <title>High Dose Suvorexant</title>
          <description>High dose sleep medication&#xD;
High Dose Suvorexant: High Dose Suvorexant</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="14"/>
                <participants group_id="P3" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="9"/>
                <participants group_id="P3" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Placebo</title>
          <description>Placebo sleep medication (Placebo oral capsule)&#xD;
Placebo oral capsule: Placebo Sleep Medication</description>
        </group>
        <group group_id="B2">
          <title>Low Dose Suvorexant</title>
          <description>Low dose sleep medication&#xD;
Low Dose Suvorexant: Low Dose Suvorexant</description>
        </group>
        <group group_id="B3">
          <title>High Dose Suvorexant</title>
          <description>High dose sleep medication&#xD;
High Dose Suvorexant: High Dose Suvorexant</description>
        </group>
        <group group_id="B4">
          <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="12"/>
            <count group_id="B2" value="14"/>
            <count group_id="B3" value="12"/>
            <count group_id="B4" value="38"/>
          </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="41.0" spread="10.4"/>
                    <measurement group_id="B2" value="36.7" spread="9.4"/>
                    <measurement group_id="B3" value="46.3" spread="12.7"/>
                    <measurement group_id="B4" value="41.1" spread="11.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="33"/>
                  </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="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                  </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 group_id="B4" 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 group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="20"/>
                  </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 group_id="B4" 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 group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Abuse Liability as Assessed by Visual Analogue Scale</title>
        <description>Area-under-the-curve of self-reported feelings of drug &quot;High&quot; on the morning after study drug administration, measured each morning on a 0-100 point visual analogue scale of the question &quot;Last night, did you feel HIGH?&quot;. A score of &quot;0&quot; indicates no abuse liability and a score of 100 indicates extreme abuse liability. This will be assessed over four nights during an opioid taper.</description>
        <time_frame>4 nights</time_frame>
        <population>Participants who completed the buprenorphine taper. 1 participant dropped out of the high dose suvorexant condition.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo sleep medication (Placebo oral capsule)&#xD;
Placebo oral capsule: Placebo Sleep Medication</description>
          </group>
          <group group_id="O2">
            <title>Low Dose Suvorexant</title>
            <description>Low dose sleep medication&#xD;
Low Dose Suvorexant: Low Dose Suvorexant</description>
          </group>
          <group group_id="O3">
            <title>High Dose Suvorexant</title>
            <description>High dose sleep medication&#xD;
High Dose Suvorexant: High Dose Suvorexant</description>
          </group>
        </group_list>
        <measure>
          <title>Abuse Liability as Assessed by Visual Analogue Scale</title>
          <description>Area-under-the-curve of self-reported feelings of drug &quot;High&quot; on the morning after study drug administration, measured each morning on a 0-100 point visual analogue scale of the question &quot;Last night, did you feel HIGH?&quot;. A score of &quot;0&quot; indicates no abuse liability and a score of 100 indicates extreme abuse liability. This will be assessed over four nights during an opioid taper.</description>
          <population>Participants who completed the buprenorphine taper. 1 participant dropped out of the high dose suvorexant condition.</population>
          <units>score on a scale*days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.9" spread="33.5"/>
                    <measurement group_id="O2" value="20.9" spread="28.7"/>
                    <measurement group_id="O3" value="22.8" spread="31.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>One-way ANOVA</non_inferiority_desc>
            <p_value>.950</p_value>
            <method>ANOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Total Sleep Time During Buprenorphine Taper</title>
        <description>Area-under-the-curve scores of total number of minutes slept per night as measured by a 3-lead wireless electroencephalography and wrist worn actigraphy.</description>
        <time_frame>Four nights during a buprenorphine taper</time_frame>
        <population>Participants who completed the buprenorphine taper. 1 participant dropped out of the high dose suvorexant condition.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo sleep medication (Placebo oral capsule)&#xD;
Placebo oral capsule: Placebo Sleep Medication</description>
          </group>
          <group group_id="O2">
            <title>Low Dose Suvorexant</title>
            <description>Low dose sleep medication&#xD;
Low Dose Suvorexant: Low Dose Suvorexant</description>
          </group>
          <group group_id="O3">
            <title>High Dose Suvorexant</title>
            <description>High dose sleep medication&#xD;
High Dose Suvorexant: High Dose Suvorexant</description>
          </group>
        </group_list>
        <measure>
          <title>Total Sleep Time During Buprenorphine Taper</title>
          <description>Area-under-the-curve scores of total number of minutes slept per night as measured by a 3-lead wireless electroencephalography and wrist worn actigraphy.</description>
          <population>Participants who completed the buprenorphine taper. 1 participant dropped out of the high dose suvorexant condition.</population>
          <units>minutes*nights</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="891.6" spread="287.9"/>
                    <measurement group_id="O2" value="1183.6" spread="300.1"/>
                    <measurement group_id="O3" value="1098.4" spread="287.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>One-way ANOVA</non_inferiority_desc>
            <p_value>.048</p_value>
            <method>ANOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Total Sleep Time During Post-taper</title>
        <description>Area-under-the-curve scores of total number of minutes slept per night as measured by a 3-lead wireless electroencephalography and wrist worn actigraphy.</description>
        <time_frame>Four nights following buprenorphine discontinuation</time_frame>
        <population>Prior to completion of the post-taper phase, 4 participants dropped out from the placebo condition, 5 dropped out from the low-dose suvorexant condition, and 3 dropped out from the high-dose suvorexant condition.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo sleep medication (Placebo oral capsule)&#xD;
Placebo oral capsule: Placebo Sleep Medication</description>
          </group>
          <group group_id="O2">
            <title>Low Dose Suvorexant</title>
            <description>Low dose sleep medication&#xD;
Low Dose Suvorexant: Low Dose Suvorexant</description>
          </group>
          <group group_id="O3">
            <title>High Dose Suvorexant</title>
            <description>High dose sleep medication&#xD;
High Dose Suvorexant: High Dose Suvorexant</description>
          </group>
        </group_list>
        <measure>
          <title>Total Sleep Time During Post-taper</title>
          <description>Area-under-the-curve scores of total number of minutes slept per night as measured by a 3-lead wireless electroencephalography and wrist worn actigraphy.</description>
          <population>Prior to completion of the post-taper phase, 4 participants dropped out from the placebo condition, 5 dropped out from the low-dose suvorexant condition, and 3 dropped out from the high-dose suvorexant condition.</population>
          <units>minutes*nights</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="9"/>
                <count group_id="O3" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1049.3" spread="253.6"/>
                    <measurement group_id="O2" value="1113.2" spread="342.1"/>
                    <measurement group_id="O3" value="1055.9" spread="274.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>One-way ANOVA</non_inferiority_desc>
            <p_value>.691</p_value>
            <method>ANOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Subjective Opiate Withdrawal Scale During Buprenorphine Taper</title>
        <description>Area-under-the-curve of peak daily scores on the Subjective Opiate Withdrawal Scale (SOWS) (a 16-item self-reported scale that measures individual opioid withdrawal symptoms using a 0-4 Likert scale; total range of SOWS is 0-64; lower scores indicate mild opioid withdrawal relative to higher scores which indicate more severe opioid withdrawal).</description>
        <time_frame>Three days during a buprenorphine taper</time_frame>
        <population>Participants who completed the buprenorphine taper. 1 participant dropped out of the high dose suvorexant condition.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo sleep medication (Placebo oral capsule)&#xD;
Placebo oral capsule: Placebo Sleep Medication</description>
          </group>
          <group group_id="O2">
            <title>Low Dose Suvorexant</title>
            <description>Low dose sleep medication&#xD;
Low Dose Suvorexant: Low Dose Suvorexant</description>
          </group>
          <group group_id="O3">
            <title>High Dose Suvorexant</title>
            <description>High dose sleep medication&#xD;
High Dose Suvorexant: High Dose Suvorexant</description>
          </group>
        </group_list>
        <measure>
          <title>Subjective Opiate Withdrawal Scale During Buprenorphine Taper</title>
          <description>Area-under-the-curve of peak daily scores on the Subjective Opiate Withdrawal Scale (SOWS) (a 16-item self-reported scale that measures individual opioid withdrawal symptoms using a 0-4 Likert scale; total range of SOWS is 0-64; lower scores indicate mild opioid withdrawal relative to higher scores which indicate more severe opioid withdrawal).</description>
          <population>Participants who completed the buprenorphine taper. 1 participant dropped out of the high dose suvorexant condition.</population>
          <units>score on a scale*days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.5" spread="12.0"/>
                    <measurement group_id="O2" value="10.8" spread="15.1"/>
                    <measurement group_id="O3" value="14.8" spread="11.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>One-way ANOVA</non_inferiority_desc>
            <p_value>.620</p_value>
            <method>ANOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Subjective Opiate Withdrawal Scale During Post-taper</title>
        <description>Area-under-the-curve of peak daily scores on the Subjective Opiate Withdrawal Scale (SOWS) (a 16-item self-reported scale that measures individual opioid withdrawal symptoms using a 0-4 Likert scale; total range of SOWS is 0-64; lower scores indicate mild opioid withdrawal relative to higher scores which indicate more severe opioid withdrawal).</description>
        <time_frame>Three days following buprenorphine discontinuation</time_frame>
        <population>Prior to completion of the post-taper phase, 4 participants dropped out from the placebo condition, 5 dropped out from the low-dose suvorexant condition, and 3 dropped out from the high-dose suvorexant condition.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo sleep medication (Placebo oral capsule)&#xD;
Placebo oral capsule: Placebo Sleep Medication</description>
          </group>
          <group group_id="O2">
            <title>Low Dose Suvorexant</title>
            <description>Low dose sleep medication&#xD;
Low Dose Suvorexant: Low Dose Suvorexant</description>
          </group>
          <group group_id="O3">
            <title>High Dose Suvorexant</title>
            <description>High dose sleep medication&#xD;
High Dose Suvorexant: High Dose Suvorexant</description>
          </group>
        </group_list>
        <measure>
          <title>Subjective Opiate Withdrawal Scale During Post-taper</title>
          <description>Area-under-the-curve of peak daily scores on the Subjective Opiate Withdrawal Scale (SOWS) (a 16-item self-reported scale that measures individual opioid withdrawal symptoms using a 0-4 Likert scale; total range of SOWS is 0-64; lower scores indicate mild opioid withdrawal relative to higher scores which indicate more severe opioid withdrawal).</description>
          <population>Prior to completion of the post-taper phase, 4 participants dropped out from the placebo condition, 5 dropped out from the low-dose suvorexant condition, and 3 dropped out from the high-dose suvorexant condition.</population>
          <units>score on a scale*days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="9"/>
                <count group_id="O3" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.9" spread="15.1"/>
                    <measurement group_id="O2" value="9.0" spread="9.8"/>
                    <measurement group_id="O3" value="6.4" spread="3.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>One-way ANOVA</non_inferiority_desc>
            <p_value>.067</p_value>
            <method>ANOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>11 days of residential treatment and 5-10 days of follow-up (16-21 days total).</time_frame>
      <desc>Adverse events represent all events rated as &quot;possibly, probably, or definitely&quot; related to study participation before and after study drug (suvorexant or placebo) administration. All participants received buprenorphine/naloxone for three days prior to randomization, and adverse events in this section may represent events that occurred prior to study drug administration but within the 11 day experimental period because some events persisted across study phases.</desc>
      <group_list>
        <group group_id="E1">
          <title>Placebo</title>
          <description>Placebo sleep medication (Placebo oral capsule)&#xD;
Placebo oral capsule: Placebo Sleep Medication</description>
        </group>
        <group group_id="E2">
          <title>Low Dose Suvorexant</title>
          <description>Low dose sleep medication&#xD;
Low Dose Suvorexant: Low Dose Suvorexant</description>
        </group>
        <group group_id="E3">
          <title>High Dose Suvorexant</title>
          <description>High dose sleep medication&#xD;
High Dose Suvorexant: High Dose Suvorexant</description>
        </group>
        <group group_id="E4">
          <title>Pre-randomization</title>
          <description>Pre-randomization to Suvorexant or placebo groups</description>
        </group>
      </group_list>
      <serious_events>
        <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="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="12"/>
                <counts group_id="E4" subjects_affected="10" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Photophobia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Blurred Vision</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Eye Pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal Cramp</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Abdominal Distention</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Abdominal Pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Indigestion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Dyspensia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Flatulance</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <description>Headache</description>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Appetite Decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Appetite Increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Pain Lower Extremity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Confusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Dream Abnormal</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="12"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Drowsiness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Euphoria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Impaired/Groggy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Light headed</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Tremor</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Stuttering/Fluency Disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Agitation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Irritability</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Prolonged Erection</sub_title>
                <description>Did not meet criteria for priapism</description>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Sweat Increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Itchy Eyes</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Andrew S. Huhn, Ph.D.</name_or_title>
      <organization>The Johns Hopkins University School of Medicine</organization>
      <phone>410-550-1971</phone>
      <email>ahuhn1@jhu.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/NCT03789214
org study id: IRB00198426
secondary id: UG3DA048734
nct id: NCT03789214
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
This study will evaluate whether a dual orexin-receptor antagonist approved by the FDA for
      sleep disturbance, suvorexant (SUVO; Belsomra), will increase total sleep time in patients
      with opioid use disorder (OUD) undergoing supervised withdrawal. This study is designed as a
      dose-finding study of SUVO compared to placebo. Briefly, OUD patients seeking supervised
      withdrawal will be admitted into a clinical research unit and stabilized onto buprenorphine
      for three days before being randomly assigned to study condition. All participants will then
      undergo a routine four-day buprenorphine taper, followed by a four-day post-taper phase.
      Participants will be randomized to receive either placebo, Low Dose SUVO, or High Dose SUVO
      and the investigators hypothesize that one or both doses of SUVO will improve total sleep
      time relative to placebo. Patients will attend a single follow-up session, 5-10 days
      following discharge.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Abuse Liability as Assessed by Visual Analogue Scale
time frame: 4 nights
description: Area-under-the-curve of self-reported feelings of drug "High" on the morning after study drug administration, measured each morning on a 0-100 point visual analogue scale of the question "Last night, did you feel HIGH?". A score of "0" indicates no abuse liability and a score of 100 indicates extreme abuse liability. This will be assessed over four nights during an opioid taper.
measure: Total Sleep Time During Buprenorphine Taper
time frame: Four nights during a buprenorphine taper
description: Area-under-the-curve scores of total number of minutes slept per night as measured by a 3-lead wireless electroencephalography and wrist worn actigraphy.
measure: Total Sleep Time During Post-taper
time frame: Four nights following buprenorphine discontinuation
description: Area-under-the-curve scores of total number of minutes slept per night as measured by a 3-lead wireless electroencephalography and wrist worn actigraphy.
measure: Subjective Opiate Withdrawal Scale During Buprenorphine Taper
time frame: Three days during a buprenorphine taper
description: Area-under-the-curve of peak daily scores on the Subjective Opiate Withdrawal Scale (SOWS) (a 16-item self-reported scale that measures individual opioid withdrawal symptoms using a 0-4 Likert scale; total range of SOWS is 0-64; lower scores indicate mild opioid withdrawal relative to higher scores which indicate more severe opioid withdrawal).
measure: Subjective Opiate Withdrawal Scale During Post-taper
time frame: Three days following buprenorphine discontinuation
description: Area-under-the-curve of peak daily scores on the Subjective Opiate Withdrawal Scale (SOWS) (a 16-item self-reported scale that measures individual opioid withdrawal symptoms using a 0-4 Likert scale; total range of SOWS is 0-64; lower scores indicate mild opioid withdrawal relative to higher scores which indicate more severe opioid withdrawal).
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo sleep medication (Placebo oral capsule)
arm group label: Low Dose Suvorexant
arm group type: Active Comparator
description: Low dose sleep medication
arm group label: High Dose Suvorexant
arm group type: Active Comparator
description: High dose sleep medication
intervention type: Drug
intervention name: Placebo oral capsule
description: Placebo Sleep Medication
arm group label: Placebo
intervention type: Drug
intervention name: Low Dose Suvorexant
description: Low Dose Suvorexant
arm group label: Low Dose Suvorexant
intervention type: Drug
intervention name: High Dose Suvorexant
description: High Dose Suvorexant
arm group label: High Dose Suvorexant
criteria: 
gender: All
gender based: Yes
gender description: Self-reported male or female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Andrew S Huhn, PhD
role: Principal Investigator
affiliation: Johns Hopkins University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Dyssomnias
mesh term: Parasomnias
mesh term: Opioid-Related Disorders
mesh term: Suvorexant
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 