<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/NCT02252068</url>
  </required_header>
  <id_info>
    <org_study_id>K23DA035297</org_study_id>
    <nct_id>NCT02252068</nct_id>
  </id_info>
  <brief_title>Study of Treatment for Opioid Dependence and Anxiety Disorders</brief_title>
  <official_title>Behavioral Treatment Development for Co-occurring Opioid Dependence and Anxiety Disorders</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mclean Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mclean Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Anxiety is highly prevalent among individuals with opioid dependence and confers greater risk&#xD;
      for continued opioid use and poor treatment outcomes. However, there are currently no&#xD;
      efficacious treatments available for co-occurring opioid dependence and anxiety. The ultimate&#xD;
      aims of this trial are the development and testing of a novel integrated cognitive behavioral&#xD;
      treatment (I-CBT) for co-occurring opioid dependence and anxiety disorders. This clinical&#xD;
      trial consists of two phases: (1) open-trial pilot (2) randomized control trial. We&#xD;
      hypothesize that I-CBT will be a feasible and acceptable treatment that will result in&#xD;
      significant reductions in anxiety and opioid use.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This Stage 1 behavioral treatment development trial involves two stages: manual development&#xD;
      and pilot testing in an open trial, and a small randomized controlled trial. In both phases,&#xD;
      opioid use and anxiety symptoms will be measured as the primary clinical outcome, along with&#xD;
      measures of feasibility and patient satisfaction. These results will be used to further&#xD;
      refine the treatment manual and to evaluate whether this treatment may enhance outcomes for&#xD;
      adults with co-occurring opioid dependence and anxiety disorders.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2015</start_date>
  <completion_date type="Actual">December 19, 2019</completion_date>
  <primary_completion_date type="Actual">October 24, 2019</primary_completion_date>
  <phase>N/A</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Urine-confirmed Self-reported Weeks of Opioid Use</measure>
    <time_frame>Week 12</time_frame>
    <description>Number of weeks of opioid use at Week 12 for the last 4 weeks of treatment (Weeks 9-12), as assessed by self-report and validated by urine drug screen</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anxiety Symptom Severity</measure>
    <time_frame>Week 12</time_frame>
    <description>Hamilton Anxiety Rating Scale (HADS) score. Measure assesses the severity of anxiety symptoms. Total scale scores are reported. Higher scores reflect worse outcome. The range of possible scores is 0-56.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of Life - General Health Score</measure>
    <time_frame>Week 12</time_frame>
    <description>Assessed by the World Health Organization Quality of Life measure, measure reflects overall health as an indicator of quality of life. The scale range of possible scores is 2-10, with higher scores reflected better outcome (i.e., better general health).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Non-opioid Substance Use</measure>
    <time_frame>Week 12</time_frame>
    <description>Days of other substance use in the past 30 days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional Impairment</measure>
    <time_frame>Week 12</time_frame>
    <description>Assessed by the Addiction Severity Index (ASI) Drug Severity Score, this score reflects the severity of functional impairment due to drug use. Higher scores reflect more interference (worse outcome) and the range of scores is 0-1.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Patient Satisfaction</measure>
    <time_frame>Week 12</time_frame>
    <description>Assessed by the Client Satisfaction Questionnaire (CSQ), this measure assesses patient satisfaction with treatment. Higher scores reflect higher satisfaction (better outcome). The scores range from 8-32.</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">37</enrollment>
  <condition>Anxiety Disorders</condition>
  <condition>Opiate Addiction</condition>
  <arm_group>
    <arm_group_label>I-CBT feasibility pilot</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Open trial of I-CBT</description>
  </arm_group>
  <arm_group>
    <arm_group_label>I-CBT randomized trial</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>I-CBT in randomized trial.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IDC randomized trial</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Comparison condition (Individualized Drug Counseling) in randomized trial.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>I-CBT</intervention_name>
    <description>New cognitive behavioral therapy treatment manual developed to treat co-occurring anxiety and opioid dependency disorders.</description>
    <arm_group_label>I-CBT feasibility pilot</arm_group_label>
    <arm_group_label>I-CBT randomized trial</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>IDC</intervention_name>
    <description>Individual Drug Counseling manual that has demonstrated efficacy for the treatment of drug dependence.</description>
    <arm_group_label>IDC randomized trial</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age 18 or older&#xD;
&#xD;
          -  meet current Diagnostic and Statistical Manual of Mental Disorders 5th edition&#xD;
             diagnostic criteria for opioid use disorder&#xD;
&#xD;
          -  currently prescribed pharmacotherapy for opioid dependence&#xD;
&#xD;
          -  have used opioids illicitly within the previous 90 days&#xD;
&#xD;
          -  clinically-significant anxiety&#xD;
&#xD;
          -  meet current diagnostic criteria for a Diagnostic and Statistical Manual of Mental&#xD;
             Disorders 5th edition anxiety disorder&#xD;
&#xD;
          -  able to read and provide informed consent&#xD;
&#xD;
          -  intend to remain in the geographical area for the duration of the study period&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  meet criteria for a current substance use or psychiatric disorder requiring a level of&#xD;
             care higher than outpatient&#xD;
&#xD;
          -  currently receiving cognitive behavioral therapy&#xD;
&#xD;
          -  recent initiation of a psychiatric medication, defined as less than 4 weeks on a&#xD;
             stable dose; not including PRN medications for sleep&#xD;
&#xD;
          -  are receiving and taking an as-needed (PRN) prescription for benzodiazepines&#xD;
&#xD;
          -  presence of a psychiatric or medical condition that would interfere with participation&#xD;
             or that requires additional care (e.g. psychosis, acute suicidality)&#xD;
&#xD;
          -  were admitted to McLean Hospital for their current treatment episode on an involuntary&#xD;
             status&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rebecca K McHugh, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mclean Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>McLean Hospital</name>
      <address>
        <city>Belmont</city>
        <state>Massachusetts</state>
        <zip>02478</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>September 25, 2014</study_first_submitted>
  <study_first_submitted_qc>September 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 29, 2014</study_first_posted>
  <results_first_submitted>September 18, 2020</results_first_submitted>
  <results_first_submitted_qc>November 10, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">November 17, 2020</results_first_posted>
  <last_update_submitted>November 10, 2020</last_update_submitted>
  <last_update_submitted_qc>November 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mclean Hospital</investigator_affiliation>
    <investigator_full_name>McHugh, R. Kathryn</investigator_full_name>
    <investigator_title>Associate Psychologist, Division of Alcohol and Drug Abuse</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Opioid-Related Disorders</mesh_term>
    <mesh_term>Anxiety Disorders</mesh_term>
  </condition_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>November 30, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/68/NCT02252068/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>In the randomized controlled trial, 6 participants completed a baseline assessment but dropped out prior to randomization.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>I-CBT Feasibility Pilot</title>
          <description>Open trial of I-CBT&#xD;
I-CBT: New cognitive behavioral therapy treatment manual developed to treat co-occurring anxiety and opioid dependency disorders.</description>
        </group>
        <group group_id="P2">
          <title>RCT I-CBT</title>
          <description>Randomized controlled trial: Integrated Cognitive-Behavioral Therapy Arm&#xD;
I-CBT: New cognitive behavioral therapy treatment manual developed to treat co-occurring anxiety and opioid dependency disorders.</description>
        </group>
        <group group_id="P3">
          <title>RCT IDC</title>
          <description>Randomized Controlled Trial: Individual Drug Counseling Arm&#xD;
IDC: Individual Drug Counseling manual that has demonstrated efficacy for the treatment of drug dependence.</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="13"/>
                <participants group_id="P3" count="13"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="13"/>
                <participants group_id="P3" count="13"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>I-CBT Feasibility Pilot</title>
          <description>Open trial of I-CBT&#xD;
I-CBT: New cognitive behavioral therapy treatment manual developed to treat co-occurring anxiety and opioid dependency disorders.</description>
        </group>
        <group group_id="B2">
          <title>I-CBT RCT</title>
          <description>Randomized control trial of I-CBT vs ICD&#xD;
I-CBT: New cognitive behavioral therapy treatment manual developed to treat co-occurring anxiety and opioid dependency disorders.</description>
        </group>
        <group group_id="B3">
          <title>IDC RCT</title>
          <description>Randomized control trial of I-CBT vs ICD&#xD;
IDC: Individual Drug Counseling manual that has demonstrated efficacy for the treatment of drug dependence.</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="5"/>
            <count group_id="B2" value="13"/>
            <count group_id="B3" value="13"/>
            <count group_id="B4" value="31"/>
          </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="31.8" spread="8.3"/>
                    <measurement group_id="B2" value="33.9" spread="10.5"/>
                    <measurement group_id="B3" value="31.8" spread="9.6"/>
                    <measurement group_id="B4" value="32.7" spread="9.6"/>
                  </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="4"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="23"/>
                  </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="0"/>
                    <measurement group_id="B4" 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="12"/>
                    <measurement group_id="B3" value="13"/>
                    <measurement group_id="B4" value="30"/>
                  </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>
          <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 group_id="B4" 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 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="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="13"/>
                    <measurement group_id="B4" value="31"/>
                  </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>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="13"/>
                    <measurement group_id="B4" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Urine-confirmed Self-reported Weeks of Opioid Use</title>
        <description>Number of weeks of opioid use at Week 12 for the last 4 weeks of treatment (Weeks 9-12), as assessed by self-report and validated by urine drug screen</description>
        <time_frame>Week 12</time_frame>
        <population>Due to partial missing data, the analysis population does not reflect the full sample. Specifically, missing data for 2 participants in RCT: I-CBT arm.</population>
        <group_list>
          <group group_id="O1">
            <title>I-CBT Feasibility Pilot</title>
            <description>Open trial of I-CBT&#xD;
I-CBT: New cognitive behavioral therapy treatment manual developed to treat co-occurring anxiety and opioid dependency disorders.</description>
          </group>
          <group group_id="O2">
            <title>RCT: I-CBT</title>
            <description>Randomized control trial of I-CBT vs ICD&#xD;
I-CBT: New cognitive behavioral therapy treatment manual developed to treat co-occurring anxiety and opioid dependency disorders.</description>
          </group>
          <group group_id="O3">
            <title>RCT IDC</title>
            <description>Randomized control trial of I-CBT vs ICD&#xD;
IDC: Individual Drug Counseling manual that has demonstrated efficacy for the treatment of drug dependence.</description>
          </group>
        </group_list>
        <measure>
          <title>Urine-confirmed Self-reported Weeks of Opioid Use</title>
          <description>Number of weeks of opioid use at Week 12 for the last 4 weeks of treatment (Weeks 9-12), as assessed by self-report and validated by urine drug screen</description>
          <population>Due to partial missing data, the analysis population does not reflect the full sample. Specifically, missing data for 2 participants in RCT: I-CBT arm.</population>
          <units>weeks</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="11"/>
                <count group_id="O3" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1" spread="1.73"/>
                    <measurement group_id="O2" value=".36" spread="1.2"/>
                    <measurement group_id="O3" value=".31" spread=".85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Anxiety Symptom Severity</title>
        <description>Hamilton Anxiety Rating Scale (HADS) score. Measure assesses the severity of anxiety symptoms. Total scale scores are reported. Higher scores reflect worse outcome. The range of possible scores is 0-56.</description>
        <time_frame>Week 12</time_frame>
        <population>Due to partial missing data, not all participants are included in this analysis. Specifically, missing data for 1 participant in the RCT: I-CBT arm.</population>
        <group_list>
          <group group_id="O1">
            <title>I-CBT Feasibility Pilot</title>
            <description>Open trial of I-CBT&#xD;
I-CBT: New cognitive behavioral therapy treatment manual developed to treat co-occurring anxiety and opioid dependency disorders.</description>
          </group>
          <group group_id="O2">
            <title>RCT: I-CBT</title>
            <description>Randomized control trial of I-CBT vs ICD&#xD;
I-CBT: New cognitive behavioral therapy treatment manual developed to treat co-occurring anxiety and opioid dependency disorders.</description>
          </group>
          <group group_id="O3">
            <title>RCT IDC</title>
            <description>Randomized control trial of I-CBT vs ICD&#xD;
IDC: Individual Drug Counseling manual that has demonstrated efficacy for the treatment of drug dependence.</description>
          </group>
        </group_list>
        <measure>
          <title>Anxiety Symptom Severity</title>
          <description>Hamilton Anxiety Rating Scale (HADS) score. Measure assesses the severity of anxiety symptoms. Total scale scores are reported. Higher scores reflect worse outcome. The range of possible scores is 0-56.</description>
          <population>Due to partial missing data, not all participants are included in this analysis. Specifically, missing data for 1 participant in the RCT: I-CBT arm.</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="12"/>
                <count group_id="O3" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.3" spread="3.1"/>
                    <measurement group_id="O2" value="14.5" spread="8.2"/>
                    <measurement group_id="O3" value="13.0" spread="8.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Quality of Life - General Health Score</title>
        <description>Assessed by the World Health Organization Quality of Life measure, measure reflects overall health as an indicator of quality of life. The scale range of possible scores is 2-10, with higher scores reflected better outcome (i.e., better general health).</description>
        <time_frame>Week 12</time_frame>
        <population>Due to partial missing data, not all participants are included in this analysis. Specifically 2 people are missing from the RCT:I-CBT arm and 3 from the RCT IDC arm.</population>
        <group_list>
          <group group_id="O1">
            <title>I-CBT Feasibility Pilot</title>
            <description>Open trial of I-CBT&#xD;
I-CBT: New cognitive behavioral therapy treatment manual developed to treat co-occurring anxiety and opioid dependency disorders.</description>
          </group>
          <group group_id="O2">
            <title>RCT: I-CBT</title>
            <description>Randomized control trial of I-CBT vs ICD&#xD;
I-CBT: New cognitive behavioral therapy treatment manual developed to treat co-occurring anxiety and opioid dependency disorders.</description>
          </group>
          <group group_id="O3">
            <title>RCT IDC</title>
            <description>Randomized control trial of I-CBT vs ICD&#xD;
IDC: Individual Drug Counseling manual that has demonstrated efficacy for the treatment of drug dependence.</description>
          </group>
        </group_list>
        <measure>
          <title>Quality of Life - General Health Score</title>
          <description>Assessed by the World Health Organization Quality of Life measure, measure reflects overall health as an indicator of quality of life. The scale range of possible scores is 2-10, with higher scores reflected better outcome (i.e., better general health).</description>
          <population>Due to partial missing data, not all participants are included in this analysis. Specifically 2 people are missing from the RCT:I-CBT arm and 3 from the RCT IDC arm.</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="11"/>
                <count group_id="O3" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.7" spread="2.9"/>
                    <measurement group_id="O2" value="5.9" spread="1.2"/>
                    <measurement group_id="O3" value="6.8" spread="1.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Non-opioid Substance Use</title>
        <description>Days of other substance use in the past 30 days</description>
        <time_frame>Week 12</time_frame>
        <group_list>
          <group group_id="O1">
            <title>I-CBT Feasibility Pilot</title>
            <description>Open trial of I-CBT&#xD;
I-CBT: New cognitive behavioral therapy treatment manual developed to treat co-occurring anxiety and opioid dependency disorders.</description>
          </group>
          <group group_id="O2">
            <title>RCT: I-CBT</title>
            <description>Randomized control trial of I-CBT vs ICD&#xD;
I-CBT: New cognitive behavioral therapy treatment manual developed to treat co-occurring anxiety and opioid dependency disorders.</description>
          </group>
          <group group_id="O3">
            <title>RCT IDC</title>
            <description>Randomized control trial of I-CBT vs ICD&#xD;
IDC: Individual Drug Counseling manual that has demonstrated efficacy for the treatment of drug dependence.</description>
          </group>
        </group_list>
        <measure>
          <title>Non-opioid Substance Use</title>
          <description>Days of other substance use in the past 30 days</description>
          <units>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="3"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.3" spread="16.2"/>
                    <measurement group_id="O2" value="4.8" spread="9.3"/>
                    <measurement group_id="O3" value="7.8" spread="13.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Functional Impairment</title>
        <description>Assessed by the Addiction Severity Index (ASI) Drug Severity Score, this score reflects the severity of functional impairment due to drug use. Higher scores reflect more interference (worse outcome) and the range of scores is 0-1.</description>
        <time_frame>Week 12</time_frame>
        <population>Due to partial missing data, 2 participants are missing from the RCT ICBT arm and 3 from the RCT IDC arm.</population>
        <group_list>
          <group group_id="O1">
            <title>I-CBT Feasibility Pilot</title>
            <description>Open trial of I-CBT&#xD;
I-CBT: New cognitive behavioral therapy treatment manual developed to treat co-occurring anxiety and opioid dependency disorders.</description>
          </group>
          <group group_id="O2">
            <title>RCT: I-CBT</title>
            <description>Randomized control trial of I-CBT vs ICD&#xD;
I-CBT: New cognitive behavioral therapy treatment manual developed to treat co-occurring anxiety and opioid dependency disorders.</description>
          </group>
          <group group_id="O3">
            <title>RCT IDC</title>
            <description>Randomized control trial of I-CBT vs ICD&#xD;
IDC: Individual Drug Counseling manual that has demonstrated efficacy for the treatment of drug dependence.</description>
          </group>
        </group_list>
        <measure>
          <title>Functional Impairment</title>
          <description>Assessed by the Addiction Severity Index (ASI) Drug Severity Score, this score reflects the severity of functional impairment due to drug use. Higher scores reflect more interference (worse outcome) and the range of scores is 0-1.</description>
          <population>Due to partial missing data, 2 participants are missing from the RCT ICBT arm and 3 from the RCT IDC arm.</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="11"/>
                <count group_id="O3" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value=".15" spread=".14"/>
                    <measurement group_id="O2" value=".10" spread=".10"/>
                    <measurement group_id="O3" value=".07" spread=".05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Patient Satisfaction</title>
        <description>Assessed by the Client Satisfaction Questionnaire (CSQ), this measure assesses patient satisfaction with treatment. Higher scores reflect higher satisfaction (better outcome). The scores range from 8-32.</description>
        <time_frame>Week 12</time_frame>
        <population>Due to partial missing data, 2 participants are missing from the RCT ICBT arm and 2 from the RCT IDC arm.</population>
        <group_list>
          <group group_id="O1">
            <title>I-CBT Feasibility Pilot</title>
            <description>Open trial of I-CBT&#xD;
I-CBT: New cognitive behavioral therapy treatment manual developed to treat co-occurring anxiety and opioid dependency disorders.</description>
          </group>
          <group group_id="O2">
            <title>RCT: I-CBT</title>
            <description>Randomized control trial of I-CBT vs ICD&#xD;
I-CBT: New cognitive behavioral therapy treatment manual developed to treat co-occurring anxiety and opioid dependency disorders.</description>
          </group>
          <group group_id="O3">
            <title>RCT IDC</title>
            <description>Randomized control trial of I-CBT vs ICD&#xD;
IDC: Individual Drug Counseling manual that has demonstrated efficacy for the treatment of drug dependence.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Satisfaction</title>
          <description>Assessed by the Client Satisfaction Questionnaire (CSQ), this measure assesses patient satisfaction with treatment. Higher scores reflect higher satisfaction (better outcome). The scores range from 8-32.</description>
          <population>Due to partial missing data, 2 participants are missing from the RCT ICBT arm and 2 from the RCT IDC arm.</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="11"/>
                <count group_id="O3" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32" spread="0"/>
                    <measurement group_id="O2" value="26.9" spread="4.8"/>
                    <measurement group_id="O3" value="29.4" spread="3.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>6 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>I-CBT Feasibility Pilot</title>
          <description>Open trial of I-CBT&#xD;
I-CBT: New cognitive behavioral therapy treatment manual developed to treat co-occurring anxiety and opioid dependency disorders.</description>
        </group>
        <group group_id="E2">
          <title>RCT I-CBT</title>
          <description>Randomized controlled trial: Integrated Cognitive-Behavioral Therapy Arm&#xD;
I-CBT: New cognitive behavioral therapy treatment manual developed to treat co-occurring anxiety and opioid dependency disorders.</description>
        </group>
        <group group_id="E3">
          <title>RCT IDC</title>
          <description>Randomized Controlled Trial: Individual Drug Counseling Arm&#xD;
IDC: Individual Drug Counseling manual that has demonstrated efficacy for the treatment of drug dependence.</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="1" subjects_at_risk="5"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
              </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="0" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
              </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>Dr. R. Kathryn McHugh</name_or_title>
      <organization>McLean Hospital</organization>
      <phone>617-855-2000</phone>
      <email>kmchugh@mclean.harvard.edu</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02252068
org study id: K23DA035297
nct id: NCT02252068
lead sponsor: 
has dmc: No
Anxiety is highly prevalent among individuals with opioid dependence and confers greater risk
      for continued opioid use and poor treatment outcomes. However, there are currently no
      efficacious treatments available for co-occurring opioid dependence and anxiety. The ultimate
      aims of this trial are the development and testing of a novel integrated cognitive behavioral
      treatment (I-CBT) for co-occurring opioid dependence and anxiety disorders. This clinical
      trial consists of two phases: (1) open-trial pilot (2) randomized control trial. We
      hypothesize that I-CBT will be a feasible and acceptable treatment that will result in
      significant reductions in anxiety and opioid use.
This Stage 1 behavioral treatment development trial involves two stages: manual development
      and pilot testing in an open trial, and a small randomized controlled trial. In both phases,
      opioid use and anxiety symptoms will be measured as the primary clinical outcome, along with
      measures of feasibility and patient satisfaction. These results will be used to further
      refine the treatment manual and to evaluate whether this treatment may enhance outcomes for
      adults with co-occurring opioid dependence and anxiety disorders.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Urine-confirmed Self-reported Weeks of Opioid Use
time frame: Week 12
description: Number of weeks of opioid use at Week 12 for the last 4 weeks of treatment (Weeks 9-12), as assessed by self-report and validated by urine drug screen
measure: Anxiety Symptom Severity
time frame: Week 12
description: Hamilton Anxiety Rating Scale (HADS) score. Measure assesses the severity of anxiety symptoms. Total scale scores are reported. Higher scores reflect worse outcome. The range of possible scores is 0-56.
measure: Quality of Life - General Health Score
time frame: Week 12
description: Assessed by the World Health Organization Quality of Life measure, measure reflects overall health as an indicator of quality of life. The scale range of possible scores is 2-10, with higher scores reflected better outcome (i.e., better general health).
measure: Non-opioid Substance Use
time frame: Week 12
description: Days of other substance use in the past 30 days
measure: Functional Impairment
time frame: Week 12
description: Assessed by the Addiction Severity Index (ASI) Drug Severity Score, this score reflects the severity of functional impairment due to drug use. Higher scores reflect more interference (worse outcome) and the range of scores is 0-1.
measure: Patient Satisfaction
time frame: Week 12
description: Assessed by the Client Satisfaction Questionnaire (CSQ), this measure assesses patient satisfaction with treatment. Higher scores reflect higher satisfaction (better outcome). The scores range from 8-32.
arm group label: I-CBT feasibility pilot
arm group type: Other
description: Open trial of I-CBT
arm group label: I-CBT randomized trial
arm group type: Experimental
description: I-CBT in randomized trial.
arm group label: IDC randomized trial
arm group type: Active Comparator
description: Comparison condition (Individualized Drug Counseling) in randomized trial.
intervention type: Behavioral
intervention name: I-CBT
description: New cognitive behavioral therapy treatment manual developed to treat co-occurring anxiety and opioid dependency disorders.
arm group label: I-CBT feasibility pilot
arm group label: I-CBT randomized trial
intervention type: Behavioral
intervention name: IDC
description: Individual Drug Counseling manual that has demonstrated efficacy for the treatment of drug dependence.
arm group label: IDC randomized trial
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Rebecca K McHugh, PhD
role: Principal Investigator
affiliation: Mclean Hospital
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Mclean Hospital
investigator full name: McHugh, R. Kathryn
investigator title: Associate Psychologist, Division of Alcohol and Drug Abuse
mesh term: Opioid-Related Disorders
mesh term: Anxiety Disorders
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 