xml: <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/NCT06032559</url>
    </required_header>
    <id_info>
      <org_study_id>Pro2022001626</org_study_id>
      <secondary_id>R01DA056537</secondary_id>
      <nct_id>NCT06032559</nct_id>
    </id_info>
    <brief_title>Implementation and Effectiveness of Mindfulness Oriented Recovery Enhancement as an Adjunct to Methadone Treatment</brief_title>
    <acronym>IMPOWR-MORE</acronym>
    <official_title>Implementation and Effectiveness of Mindfulness Oriented Recovery Enhancement as an Adjunct to Methadone Treatment for Opioid Use Disorder and Chronic Pain</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Rutgers, The State University of New Jersey</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Institute on Drug Abuse (NIDA)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of Utah</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Rutgers, The State University of New Jersey</source>
    <oversight_info>
      <has_dmc>Yes</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>
        This hybrid implementation-effectiveness trial will evaluate Mindfulness-Oriented Recovery&#xD;
        Enhancement (MORE) for patients with opioid use disorder receiving methadone treatment (MT).&#xD;
        We will also assess barriers and facilitators to integrating MORE into methadone treatment,&#xD;
        and evaluate the impact of a sustainable train-the-trainer model on provider burden,&#xD;
        intervention fidelity, intervention engagement, and outcomes. Participants will be assigned&#xD;
        to a higher intensity MORE implementation strategy, a minimal intensity implementation&#xD;
        strategy consisting of a simple, scripted mindfulness practice (SMP) extracted from the MORE&#xD;
        treatment manual with minimal training and feedback and no supervision, or methadone&#xD;
        treatment as usual (TAU). We aim to:&#xD;
  &#xD;
          -  Examine barriers and facilitators to the implementation of MORE and SMP in MT and&#xD;
             evaluate strategies for optimizing training, fidelity, and engagement.&#xD;
  &#xD;
          -  Evaluate the effectiveness and treatment fidelity of a higher intensity MORE&#xD;
             implementation strategy versus a lower intensity, scripted mindfulness practice (SMP)&#xD;
             implementation strategy as an adjunct to methadone TAU or methadone TAU, only. Outcomes&#xD;
             include opioid and other drug use, craving, MT discontinuation, depression, anxiety, and&#xD;
             physical pain (secondary outcomes) than patients randomized to TAU.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 6, 2023</start_date>
    <completion_date type="Anticipated">March 30, 2027</completion_date>
    <primary_completion_date type="Anticipated">March 30, 2026</primary_completion_date>
    <phase>Phase 3</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>Double (Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Days of drug use</measure>
      <time_frame>Baseline through 52 weeks</time_frame>
      <description>mber of days of drug use as measured by self-reported days of use and biochemically verified use via drug screen.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Chronic Pain</measure>
      <time_frame>Baseline through 52 weeks</time_frame>
      <description>Chronic pain measured by the Brief Pain Inventory Short Form (range 0-10, with higher scores indicating worse pain).</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">450</enrollment>
    <condition>Opioid Use</condition>
    <condition>Pain</condition>
    <arm_group>
      <arm_group_label>MORE</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Eight group sessions of Mindfulness-Oriented Recovery Enhancement plus methadone treatment as usual (TAU)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Scripted Mindfulness Practice (SMP)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Eight group sessions of scripted mindfulness practice plus TAU.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Treatment-as-Usual</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Methadone treatment as usual.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>MORE</intervention_name>
      <description>MORE plus TAU</description>
      <arm_group_label>MORE</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>SMP</intervention_name>
      <description>SMP plus TAU</description>
      <arm_group_label>Scripted Mindfulness Practice (SMP)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>TAU</intervention_name>
      <description>TAU only</description>
      <arm_group_label>Treatment-as-Usual</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  1) English-speaking; 2) age ≥18; 3) currently on methadone; and 4) persistent or&#xD;
               recurring pain that has lasted for a duration of 3 months of longer.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  1) severe cognitive impairment (score &gt;23 on Mini Mental Status Exam)76 or psychosis&#xD;
               (positive SCID Psychotic Screen),77 2) suicidal risk (score ≥7 on Suicidal Behaviors&#xD;
               Questionnaire),78 3) inability to attend or fully participate in intervention sessions&#xD;
               or assessments, and 4) previous formal mindfulness training (e.g., MBSR, MBRP) or MORE&#xD;
               (from the R21 or R33 studies).&#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>Eric Garland, Ph</last_name>
      <role>Principal Investigator</role>
      <affiliation>Rutgers Robert Wood Johnson Medical School</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Nina Cooperman, PsyD</last_name>
      <phone>732-235-8569</phone>
      <email>cooperna@rwjms.rutgers.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Eric Garland, PhD</last_name>
      <phone>801-581-3826</phone>
      <email>eric.garland@socwk.utah.edu</email>
    </overall_contact_backup>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 4, 2023</study_first_submitted>
    <study_first_submitted_qc>September 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 4, 2023</last_update_submitted>
    <last_update_submitted_qc>September 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Rutgers, The State University of New Jersey</investigator_affiliation>
      <investigator_full_name>Nina A. Cooperman, Psy. D.</investigator_full_name>
      <investigator_title>Associate Professor</investigator_title>
    </responsible_party>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>All participant data collected during the trial will be shared after de-identification.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_time_frame>Beginning 3 months and ending five years after study publication.</ipd_time_frame>
      <ipd_access_criteria>Researchers who provide a methodologically sound proposal.</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06032559
  org study id: Pro2022001626
  secondary id: R01DA056537
  nct id: NCT06032559
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  This hybrid implementation-effectiveness trial will evaluate Mindfulness-Oriented Recovery
        Enhancement (MORE) for patients with opioid use disorder receiving methadone treatment (MT).
        We will also assess barriers and facilitators to integrating MORE into methadone treatment,
        and evaluate the impact of a sustainable train-the-trainer model on provider burden,
        intervention fidelity, intervention engagement, and outcomes. Participants will be assigned
        to a higher intensity MORE implementation strategy, a minimal intensity implementation
        strategy consisting of a simple, scripted mindfulness practice (SMP) extracted from the MORE
        treatment manual with minimal training and feedback and no supervision, or methadone
        treatment as usual (TAU). We aim to:
  
          -  Examine barriers and facilitators to the implementation of MORE and SMP in MT and
             evaluate strategies for optimizing training, fidelity, and engagement.
  
          -  Evaluate the effectiveness and treatment fidelity of a higher intensity MORE
             implementation strategy versus a lower intensity, scripted mindfulness practice (SMP)
             implementation strategy as an adjunct to methadone TAU or methadone TAU, only. Outcomes
             include opioid and other drug use, craving, MT discontinuation, depression, anxiety, and
             physical pain (secondary outcomes) than patients randomized to TAU.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Investigator, Outcomes Assessor)
  measure: Days of drug use
  time frame: Baseline through 52 weeks
  description: mber of days of drug use as measured by self-reported days of use and biochemically verified use via drug screen.
  measure: Chronic Pain
  time frame: Baseline through 52 weeks
  description: Chronic pain measured by the Brief Pain Inventory Short Form (range 0-10, with higher scores indicating worse pain).
  arm group label: MORE
  arm group type: Experimental
  description: Eight group sessions of Mindfulness-Oriented Recovery Enhancement plus methadone treatment as usual (TAU)
  arm group label: Scripted Mindfulness Practice (SMP)
  arm group type: Active Comparator
  description: Eight group sessions of scripted mindfulness practice plus TAU.
  arm group label: Treatment-as-Usual
  arm group type: Active Comparator
  description: Methadone treatment as usual.
  intervention type: Behavioral
  intervention name: MORE
  description: MORE plus TAU
  arm group label: MORE
  intervention type: Behavioral
  intervention name: SMP
  description: SMP plus TAU
  arm group label: Scripted Mindfulness Practice (SMP)
  intervention type: Other
  intervention name: TAU
  description: TAU only
  arm group label: Treatment-as-Usual
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Eric Garland, Ph
  role: Principal Investigator
  affiliation: Rutgers Robert Wood Johnson Medical School
  last name: Nina Cooperman, PsyD
  phone: 732-235-8569
  email: cooperna@rwjms.rutgers.edu
  last name: Eric Garland, PhD
  phone: 801-581-3826
  email: eric.garland@socwk.utah.edu
  responsible party type: Principal Investigator
  investigator affiliation: Rutgers, The State University of New Jersey
  investigator full name: Nina A. Cooperman, Psy. D.
  investigator title: Associate Professor
  sharing ipd: Yes
  ipd description: All participant data collected during the trial will be shared after de-identification.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd info type: Clinical Study Report (CSR)
  ipd time frame: Beginning 3 months and ending five years after study publication.
  ipd access criteria: Researchers who provide a methodologically sound proposal.