<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/NCT03298269</url>
  </required_header>
  <id_info>
    <org_study_id>1618</org_study_id>
    <nct_id>NCT03298269</nct_id>
  </id_info>
  <brief_title>Behavioral Interventions for Chronic Pain and Opioid-Related Problems</brief_title>
  <official_title>Behavioral Interventions for Chronic Pain and Opioid-Related Problems</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Utah</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Utah</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to examine the effects of Mindfulness-Oriented Recovery&#xD;
      Enhancement versus a social support group (supportive counseling) intervention for chronic&#xD;
      pain patients receiving long-term opioid pharmacotherapy for pain.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 26, 2017</start_date>
  <completion_date type="Actual">October 1, 2020</completion_date>
  <primary_completion_date type="Actual">October 1, 2020</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>Change in pain symptoms</measure>
    <time_frame>Change from baseline through study completion (9 months post-treatment)</time_frame>
    <description>Pain severity and interference as measured by the Brief Pain Inventory</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in aberrant drug-related behaviors</measure>
    <time_frame>Change from baseline through study completion (9 months post-treatment)</time_frame>
    <description>Aberrant drug-related behaviors as evidenced by triangulated aggregate of Current Opioid Misuse Measure and/or clinician assessment via Addiction Behaviors Checklist and/or urine screen</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in emotional distress</measure>
    <time_frame>Change from baseline through study completion (9 months post-treatment)</time_frame>
    <description>Distress measured by the Depression, Anxiety, Stress Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in opioid dose</measure>
    <time_frame>Change from baseline through study completion (9 months post-treatment)</time_frame>
    <description>Opioid dose converted into morphine equivalents via standardized equianalgesic tables</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in opioid craving</measure>
    <time_frame>Change from baseline through study completion (9 months post-treatment)</time_frame>
    <description>Craving measured by visual analogue scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in interoceptive awareness</measure>
    <time_frame>Change from baseline through 8 weeks</time_frame>
    <description>Interoceptive awareness measured by the Multidimensional Assessment of Interoceptive Awareness</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in reappraisal</measure>
    <time_frame>Change from baseline through 8 weeks</time_frame>
    <description>Reappraisal measured by the Emotion Regulation Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in savoring</measure>
    <time_frame>Change from baseline through 8 weeks</time_frame>
    <description>Savoring measured by the brief Ways of Savoring checklist</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in meditative experiences</measure>
    <time_frame>Change from baseline through 8 weeks</time_frame>
    <description>As measured by the Five Facet Mindfulness Questionnaire, self-salience and self-extension items, and/or Nondual Awareness Dimensional Assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in body sensations</measure>
    <time_frame>Change from baseline through 8 weeks</time_frame>
    <description>Change in pleasant, neutral, and unpleasant body sensations as measured by body map</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in cue-reactivity</measure>
    <time_frame>Change from baseline through 8 weeks</time_frame>
    <description>Change in EEG responses during a cue-reactivity task</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in emotion regulation</measure>
    <time_frame>Change from baseline through 8 weeks</time_frame>
    <description>Change in EEG responses during an emotion regulation task</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">95</enrollment>
  <condition>Chronic Pain</condition>
  <arm_group>
    <arm_group_label>Mindfulness-Oriented Recovery Enhancement</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Supportive Counseling</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mindfulness-Oriented Recovery Enhancement</intervention_name>
    <description>Mindfulness-Oriented Recovery Enhancement (MORE) is a group behavioral intervention led by a therapist that combines training in mindfulness, cognitive reappraisal, and savoring skills.</description>
    <arm_group_label>Mindfulness-Oriented Recovery Enhancement</arm_group_label>
    <other_name>MORE</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Supportive Counseling</intervention_name>
    <description>A support group led by a therapist will allow participants to express emotions, share experiences, and receive social support.</description>
    <arm_group_label>Supportive Counseling</arm_group_label>
    <other_name>Support Group</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18-60+&#xD;
&#xD;
          -  Current chronic pain condition&#xD;
&#xD;
          -  Current use of prescription opioid agonist or mixed agonist-antagonist analgesics for&#xD;
             &gt;90 days&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior experience with Mindfulness-Based Stress Reduction, Mindfulness-Based Cognitive&#xD;
             Therapy, or Mindfulness-Based Relapse Prevention&#xD;
&#xD;
          -  Active suicidality, schizophrenia, psychotic disorder, and/or severe substance&#xD;
             dependence (other than opioid dependence)&#xD;
&#xD;
          -  Opioid misuse as determined by Current Opioid Misuse Measure&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>College of Social Work</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>September 26, 2017</study_first_submitted>
  <study_first_submitted_qc>September 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 2, 2017</study_first_posted>
  <last_update_submitted>December 8, 2021</last_update_submitted>
  <last_update_submitted_qc>December 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 10, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Utah</investigator_affiliation>
    <investigator_full_name>Eric Garland</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chronic Pain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03298269
org study id: 1618
nct id: NCT03298269
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to examine the effects of Mindfulness-Oriented Recovery
      Enhancement versus a social support group (supportive counseling) intervention for chronic
      pain patients receiving long-term opioid pharmacotherapy for pain.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change in pain symptoms
time frame: Change from baseline through study completion (9 months post-treatment)
description: Pain severity and interference as measured by the Brief Pain Inventory
measure: Change in aberrant drug-related behaviors
time frame: Change from baseline through study completion (9 months post-treatment)
description: Aberrant drug-related behaviors as evidenced by triangulated aggregate of Current Opioid Misuse Measure and/or clinician assessment via Addiction Behaviors Checklist and/or urine screen
measure: Change in emotional distress
time frame: Change from baseline through study completion (9 months post-treatment)
description: Distress measured by the Depression, Anxiety, Stress Scale
measure: Change in opioid dose
time frame: Change from baseline through study completion (9 months post-treatment)
description: Opioid dose converted into morphine equivalents via standardized equianalgesic tables
measure: Change in opioid craving
time frame: Change from baseline through study completion (9 months post-treatment)
description: Craving measured by visual analogue scale
measure: Change in interoceptive awareness
time frame: Change from baseline through 8 weeks
description: Interoceptive awareness measured by the Multidimensional Assessment of Interoceptive Awareness
measure: Change in reappraisal
time frame: Change from baseline through 8 weeks
description: Reappraisal measured by the Emotion Regulation Questionnaire
measure: Change in savoring
time frame: Change from baseline through 8 weeks
description: Savoring measured by the brief Ways of Savoring checklist
measure: Change in meditative experiences
time frame: Change from baseline through 8 weeks
description: As measured by the Five Facet Mindfulness Questionnaire, self-salience and self-extension items, and/or Nondual Awareness Dimensional Assessment
measure: Change in body sensations
time frame: Change from baseline through 8 weeks
description: Change in pleasant, neutral, and unpleasant body sensations as measured by body map
measure: Change in cue-reactivity
time frame: Change from baseline through 8 weeks
description: Change in EEG responses during a cue-reactivity task
measure: Change in emotion regulation
time frame: Change from baseline through 8 weeks
description: Change in EEG responses during an emotion regulation task
arm group label: Mindfulness-Oriented Recovery Enhancement
arm group type: Experimental
arm group label: Supportive Counseling
arm group type: Active Comparator
intervention type: Behavioral
intervention name: Mindfulness-Oriented Recovery Enhancement
description: Mindfulness-Oriented Recovery Enhancement (MORE) is a group behavioral intervention led by a therapist that combines training in mindfulness, cognitive reappraisal, and savoring skills.
arm group label: Mindfulness-Oriented Recovery Enhancement
other name: MORE
intervention type: Behavioral
intervention name: Supportive Counseling
description: A support group led by a therapist will allow participants to express emotions, share experiences, and receive social support.
arm group label: Supportive Counseling
other name: Support Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Utah
investigator full name: Eric Garland
investigator title: Professor
mesh term: Chronic Pain
sharing ipd: Undecided