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/NCT06033599</url>
    </required_header>
    <id_info>
      <org_study_id>Pro2022001551</org_study_id>
      <secondary_id>R01DA057631</secondary_id>
      <nct_id>NCT06033599</nct_id>
    </id_info>
    <brief_title>Motivational Interviewing and Mindfulness-Oriented Recovery Enhancement</brief_title>
    <official_title>Motivational Interviewing (MI) and Mindfulness-Oriented Recovery Enhancement (MORE) for Tobacco Dependence and Other Drug Use in Methadone Treatment</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Rutgers, The State University of New Jersey</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>University of Utah</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>National Institute on Drug Abuse (NIDA)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>Rutgers, The State University of New Jersey</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this study is to 1) examine barriers and facilitators to implementation of MI&#xD;
        and MORE for polysubstance use and evaluate strategies for optimizing training, fidelity, and&#xD;
        clinic uptake, and 2) evaluate patient outcomes related to the effectiveness of MORE&#xD;
        decreasing opioid, tobacco, and other drug use.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 5, 2023</start_date>
    <completion_date type="Anticipated">June 30, 2027</completion_date>
    <primary_completion_date type="Anticipated">June 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>Factorial 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>Number of days of drug use as measured by self-reported days of use and biochemically verified use via drug screen.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Days of Tobacco Use</measure>
      <time_frame>Baseline through 52 weeks.</time_frame>
      <description>Number of days of tobacco use as measured by self-reported days of use and biochemically verified use via expired carbon monoxide.</description>
    </primary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">420</enrollment>
    <condition>Polysubstance Abuse</condition>
    <condition>Opioid Use</condition>
    <condition>Tobacco Use</condition>
    <arm_group>
      <arm_group_label>MORE and MI</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>MORE and No MI</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Support Group and MI</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Support Group and No MI</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>MORE and MI and NRT</intervention_name>
      <description>Eight group Mindfulness Oriented Recovery Enhancement sessions and one motivational interviewing session and nicotine replacement therapy.</description>
      <arm_group_label>MORE and MI</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>MORE and No MI and NRT</intervention_name>
      <description>Eight group Mindfulness Oriented Recovery Enhancement sessions and nicotine replacement therapy.</description>
      <arm_group_label>MORE and No MI</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Support Group and MI and NRT</intervention_name>
      <description>Eight group support group sessions and one motivational interviewing session and nicotine replacement therapy.</description>
      <arm_group_label>Support Group and MI</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Support Group and No MI and NRT</intervention_name>
      <description>Eight group support group sessions and and nicotine replacement therapy.</description>
      <arm_group_label>Support Group and No MI</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  1) English-speaking; 2) age ≥18; 3) currently on methadone; and 4) currently smoke&#xD;
               cigarettes.&#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, 4) previous formal mindfulness training (e.g., MBSR, MBRP) or MORE&#xD;
               (from the R21 or R33 studies), 5) currently taking smoking cessation pharmacotherapy&#xD;
               or participating in smoking cessation counseling, 6) any contraindications for NRT,&#xD;
               and 7) currently or soon planning to be pregnant or breastfeeding.&#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>Nina Cooperman, PsyD</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 5, 2023</study_first_submitted>
    <study_first_submitted_qc>September 5, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 5, 2023</last_update_submitted>
    <last_update_submitted_qc>September 5, 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 individual data will be available 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_info_type>Analytic Code</ipd_info_type>
      <ipd_time_frame>Data will be available three months through 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/NCT06033599
  org study id: Pro2022001551
  secondary id: R01DA057631
  nct id: NCT06033599
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: Yes
  The purpose of this study is to 1) examine barriers and facilitators to implementation of MI
        and MORE for polysubstance use and evaluate strategies for optimizing training, fidelity, and
        clinic uptake, and 2) evaluate patient outcomes related to the effectiveness of MORE
        decreasing opioid, tobacco, and other drug use.
  allocation: Randomized
  intervention model: Factorial Assignment
  primary purpose: Treatment
  masking: Double (Investigator, Outcomes Assessor)
  measure: Days of Drug Use
  time frame: Baseline through 52 weeks.
  description: Number of days of drug use as measured by self-reported days of use and biochemically verified use via drug screen.
  measure: Days of Tobacco Use
  time frame: Baseline through 52 weeks.
  description: Number of days of tobacco use as measured by self-reported days of use and biochemically verified use via expired carbon monoxide.
  arm group label: MORE and MI
  arm group type: Experimental
  arm group label: MORE and No MI
  arm group type: Experimental
  arm group label: Support Group and MI
  arm group type: Active Comparator
  arm group label: Support Group and No MI
  arm group type: Active Comparator
  intervention type: Other
  intervention name: MORE and MI and NRT
  description: Eight group Mindfulness Oriented Recovery Enhancement sessions and one motivational interviewing session and nicotine replacement therapy.
  arm group label: MORE and MI
  intervention type: Other
  intervention name: MORE and No MI and NRT
  description: Eight group Mindfulness Oriented Recovery Enhancement sessions and nicotine replacement therapy.
  arm group label: MORE and No MI
  intervention type: Other
  intervention name: Support Group and MI and NRT
  description: Eight group support group sessions and one motivational interviewing session and nicotine replacement therapy.
  arm group label: Support Group and MI
  intervention type: Other
  intervention name: Support Group and No MI and NRT
  description: Eight group support group sessions and and nicotine replacement therapy.
  arm group label: Support Group and No MI
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Nina Cooperman, PsyD
  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 individual data will be available 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 info type: Analytic Code
  ipd time frame: Data will be available three months through five years after study publication
  ipd access criteria: Researchers who provide a methodologically sound proposal.