<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/NCT04491968</url>
  </required_header>
  <id_info>
    <org_study_id>R33 AT01009</org_study_id>
    <nct_id>NCT04491968</nct_id>
  </id_info>
  <brief_title>Mindfulness Oriented Recovery Enhancement for Chronic Pain and Opioid Relapse</brief_title>
  <official_title>Mindfulness Oriented Recovery Enhancement for Chronic Pain and Opioid Relapse as an Adjunct to 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>
  </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>
      The objective of this study is to rigorously examine the impact of online MORE, delivered&#xD;
      through video conference, on opioid use and chronic pain among individuals receiving&#xD;
      methadone maintenance treatment (MMT). This study is a randomized controlled trial to test&#xD;
      the efficacy of online MORE on opioid use and chronic pain immediately after treatment and&#xD;
      8-weeks post-treatment as compared to treatment as usual (TAU) among 154 individuals in MMT.&#xD;
      Further, mediators (i.e., metacognitive awareness, negative emotion regulation, and natural&#xD;
      reward processing) and moderators (i.e., gender, race, income, mental health, trauma, and MMT&#xD;
      phase) of treatment response will be explored.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a 2-arm individually randomized controlled trial design in which outcomes of&#xD;
      MMT patients randomized to MORE are compared to outcomes of those randomized to treatment as&#xD;
      usual (TAU). In this study (N=154), the investigators will randomize MMT patients with&#xD;
      chronic pain to MORE (n=77) or TAU (n=77). The purpose of this study is to determine MORE's&#xD;
      efficacy for increasing opioid abstinence relative to TAU. Individuals with pain who are&#xD;
      receiving MMT for an opioid use disorder (OUD) will be recruited from two methadone clinics&#xD;
      in New Jersey.&#xD;
&#xD;
      Participants will be recruited through flyers posted in the clinics, being approached by&#xD;
      research assistants in the waiting room of their usual methadone clinic, and referral by&#xD;
      clinic staff. The number of individuals who contact the study staff through the flyers or&#xD;
      referral and who are approached by study staff in the clinics will be tracked. Number of&#xD;
      individuals who refuse study participation and who consent to the study will also be tracked.&#xD;
      If an individual is interested in study participation, a trained research assistant will lead&#xD;
      the individual through the informed consent process in a private space.&#xD;
&#xD;
      Since MORE is a closed group, the cohorts of 14 participants at each site will be randomized&#xD;
      to TAU or MORE. Once 14 participants at a particular clinic are enrolled and randomized the&#xD;
      MORE group will begin.&#xD;
&#xD;
      Participants randomized to the MORE condition will participate in eight, weekly, two-hour&#xD;
      group sessions, co-led by a clinic and study counselor. Each session will contain 7&#xD;
      participants and take place remotely, by video conference. Attendance at each session and&#xD;
      reasons for missing sessions will be recorded. Participants randomized to the control&#xD;
      condition will continue receiving treatment as usual.&#xD;
&#xD;
      All study participants will partake in a total of three interviews lasting up to 90 minutes&#xD;
      and occurring, remotely, at baseline, 8- and 16- weeks post-baseline by telephone or video&#xD;
      conference. Each participant will also complete a urine or saliva drug screen at each&#xD;
      assessment. All attempts to reach participants to schedule follow-up assessments will be&#xD;
      tracked. Participants will also complete cognitive testing (for approx. 30-45 minutes) at&#xD;
      baseline and 8-weeks and ecological momentary assessments (EMA) conducted via smartphones or&#xD;
      tablets, which will be provided to each participant by study staff. EMA participation will&#xD;
      require the participant to respond to twice-daily prompts in which they will be asked a&#xD;
      series of brief questions regarding their current mood and exposure to opioid triggers.&#xD;
      Additionally, subjects will be asked to initiate responses when they experience serious&#xD;
      craving or relapse to opioid use. Each EMA assessment will last approximately 3-5 minutes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 13, 2020</start_date>
  <completion_date type="Actual">June 8, 2022</completion_date>
  <primary_completion_date type="Actual">June 8, 2022</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>
    <intervention_model_description>Two-arm randomized controlled trial.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Opioid relapse through 16-weeks.</measure>
    <time_frame>16-weeks</time_frame>
    <description>Number of days until first opioid use as measured by self-report through EMA, follow-back, or urine screen.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Methadone treatment retention through 16-weeks.</measure>
    <time_frame>16-weeks</time_frame>
    <description>Number of days to methadone dosing lapse or discontinuation as measured by EMA, follow-back, clinic charts, or urine screen.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Opioid abstinence versus any opioid use.</measure>
    <time_frame>8-weeks</time_frame>
    <description>Used opioids or not at 8-weeks as measured by self-report through EMA or timeline follow-back and verified by urine or saliva drug screen.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Opioid abstinence versus any opioid use.</measure>
    <time_frame>16-weeks</time_frame>
    <description>Used opioids or not as measured by self-report through EMA or timeline follow-back and verified by urine or saliva drug screen.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Other drug abstinence versus other drug use.</measure>
    <time_frame>8-weeks</time_frame>
    <description>Used other drugs or not as measured by self-report through EMA or timeline follow-back and verified by urine or saliva drug screen.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Other drug abstinence versus other drug use.</measure>
    <time_frame>16-weeks</time_frame>
    <description>Uses other drugs or not as measured by self-report through EMA or timeline follow-back and verified by urine or saliva drug screen.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of days of opioid use.</measure>
    <time_frame>8-weeks</time_frame>
    <description>Number of days of opioid use as measured by self-report through EMA or timeline follow-back and verified by urine or saliva drug screen.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of days of opioid use.</measure>
    <time_frame>16-weeks</time_frame>
    <description>Number of days of opioid use as measured by self-report through EMA or timeline follow-back and verified by urine or saliva drug screen.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of days of other drug use.</measure>
    <time_frame>16-weeks</time_frame>
    <description>Number of days of other drug use as measured by self-report through EMA or timeline follow-back and verified by urine or saliva drug screen.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Craving level.</measure>
    <time_frame>8-weeks</time_frame>
    <description>Penn Alcohol Craving Scale score on a range from 0 (e.g., no craving) to 6 (intense craving) or EMA.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Craving level.</measure>
    <time_frame>16-weeks</time_frame>
    <description>Penn Alcohol Craving Scale score on a range from 0 (e.g., no craving) to 6 (intense craving) or EMA .</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain level.</measure>
    <time_frame>8-weeks</time_frame>
    <description>Brief Pain Inventory score on a scale from 0 (no pain) to 10 (pain as bad as you can imagine) or EMA.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain level.</measure>
    <time_frame>16-weeks</time_frame>
    <description>Brief Pain Inventory score on a scale from 0 (no pain) to 10 (pain as bad as you can imagine) or EMA.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Emotional Distress</measure>
    <time_frame>8-weeks</time_frame>
    <description>Beck Anxiety Inventory score on a scale from 0 (no anxiety) to 63 (severe anxiety) and Center for Epidemiology Scale for Depression scored on a scale from 0 (no depression) to 60 (severe depression) or EMA.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Emotional Distress</measure>
    <time_frame>16-weeks</time_frame>
    <description>Beck Anxiety Inventory score on a scale from 0 (no anxiety) to 63 (severe anxiety) and Center for Epidemiology Scale for Depression scored on a scale from 0 (no depression) to 60 (severe depression) or EMA.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Positive Affect.</measure>
    <time_frame>8-weeks</time_frame>
    <description>Positive feelings on a scale from 0 (not at all positive) to 10 (very positive)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Positive Affect.</measure>
    <time_frame>16-weeks.</time_frame>
    <description>Positive feelings on a scale from 0 (not at all positive) to 10 (very positive)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">154</enrollment>
  <condition>Opioid Use</condition>
  <condition>Chronic Pain</condition>
  <arm_group>
    <arm_group_label>Mindfulness Oriented Recovery Enhancement</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The Mindfulness Oriented Recovery Enhancement arm will participate in eight, weekly, two-hour group sessions.MORE sessions involve mindfulness training to prevent opioid relapse and reduce pain, cognitive reappraisal to decrease negative affect and regulate opioid craving, and savoring to augment natural reward processing and evoke positive emotion. Each session begins with a mindful breathing meditation, followed by a debriefing session. The therapist then debriefs participants' homework practice of using mindfulness, reappraisal, and savoring skills to cope with pain and enhance well-being in everyday life. During this debrief of the homework. Next, new psychoeducational material is introduced. Sessions culminate with an experiential exercise, and close with a brief mindful breathing meditation. Participants are asked to practice 15 minutes of mindfulness/reappraisal/savoring skills each day.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Methadone Treatment as Usual</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>In the methadone programs, clients typically come to the clinic regularly to get their methadone dose. Clients see their clinic substance abuse counselor for individual counseling, usually weekly at the beginning of treatment, with decreasing frequency if they remain abstinent and progress through treatment. Depending on clients' stage of MMT and success with remaining abstinent from drugs, they may be required to attend clinic treatment groups. Also, some clients may choose to go to voluntary counseling, educational, or support groups.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mindfulness Oriented Recovery Enhancement</intervention_name>
    <description>MORE sessions involve mindfulness training to prevent opioid relapse and reduce pain, cognitive reappraisal to decrease negative affect and regulate opioid craving, and savoring to augment natural reward processing and evoke positive emotion. Each session begins with a mindful breathing meditation, followed by a debriefing session. The therapist then debriefs participants' homework practice of using mindfulness, reappraisal, and savoring skills to cope with pain and enhance well-being in everyday life. During this debrief of the homework. Next, new psychoeducational material is introduced. Sessions culminate with an experiential exercise, and close with a brief mindful breathing meditation. Participants are asked to practice 15 minutes of mindfulness/reappraisal/savoring skills each day.</description>
    <arm_group_label>Mindfulness Oriented Recovery Enhancement</arm_group_label>
    <other_name>MORE</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Methadone Treatment as Usual</intervention_name>
    <description>In the methadone programs, clients typically come to the clinic regularly to get their methadone dose. Clients see their clinic substance abuse counselor for individual counseling, usually weekly at the beginning of treatment, with decreasing frequency if they remain abstinent and progress through treatment. Depending on clients' stage of MMT and success with remaining abstinent from drugs, they may be required to attend clinic treatment groups. Also, some clients may choose to go to voluntary counseling, educational, or support groups.</description>
    <arm_group_label>Methadone Treatment as Usual</arm_group_label>
    <other_name>MMT, Treatment as Usual, TAU</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  English-speaking&#xD;
&#xD;
          -  Age ≥18&#xD;
&#xD;
          -  Currently on methadone&#xD;
&#xD;
          -  Experiencing non-malignant pain for a duration of 3 months or longer.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe cognitive impairment or active psychosis&#xD;
&#xD;
          -  Suicide risk&#xD;
&#xD;
          -  Inability to attend the MORE group, if randomized to that arm.&#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>
  <location>
    <facility>
      <name>Rutgers Robert Wood Johnson Medical School</name>
      <address>
        <city>New Brunswick</city>
        <state>New Jersey</state>
        <zip>08901</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>July 9, 2020</study_first_submitted>
  <study_first_submitted_qc>July 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 30, 2020</study_first_posted>
  <last_update_submitted>December 21, 2022</last_update_submitted>
  <last_update_submitted_qc>December 21, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 27, 2022</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>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chronic Pain</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Methadone</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Analyses of data generated from this project will be shared with the scientific community through publications in peer-reviewed journals and presentations at scientific meetings. The proposed research will include data from approximately 154 individuals in methadone maintenance treatment. The final dataset will include self-reported demographic and behavioral data from interviews with the subjects and laboratory data from urine or saliva specimens provided. Because we will be following study participants, we will be collecting identifying information. The final dataset will be stripped of identifiers prior to release for sharing.</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>Beginning 3 months and ending 36 months after study publication.</ipd_time_frame>
    <ipd_access_criteria>Data and associated documentation will be available to research community scientists only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.</ipd_access_criteria>
  </patient_data>
  <provided_document_section>
    <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>December 28, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/68/NCT04491968/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT04491968
org study id: R33 AT01009
nct id: NCT04491968
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The objective of this study is to rigorously examine the impact of online MORE, delivered
      through video conference, on opioid use and chronic pain among individuals receiving
      methadone maintenance treatment (MMT). This study is a randomized controlled trial to test
      the efficacy of online MORE on opioid use and chronic pain immediately after treatment and
      8-weeks post-treatment as compared to treatment as usual (TAU) among 154 individuals in MMT.
      Further, mediators (i.e., metacognitive awareness, negative emotion regulation, and natural
      reward processing) and moderators (i.e., gender, race, income, mental health, trauma, and MMT
      phase) of treatment response will be explored.
This study is a 2-arm individually randomized controlled trial design in which outcomes of
      MMT patients randomized to MORE are compared to outcomes of those randomized to treatment as
      usual (TAU). In this study (N=154), the investigators will randomize MMT patients with
      chronic pain to MORE (n=77) or TAU (n=77). The purpose of this study is to determine MORE's
      efficacy for increasing opioid abstinence relative to TAU. Individuals with pain who are
      receiving MMT for an opioid use disorder (OUD) will be recruited from two methadone clinics
      in New Jersey.

      Participants will be recruited through flyers posted in the clinics, being approached by
      research assistants in the waiting room of their usual methadone clinic, and referral by
      clinic staff. The number of individuals who contact the study staff through the flyers or
      referral and who are approached by study staff in the clinics will be tracked. Number of
      individuals who refuse study participation and who consent to the study will also be tracked.
      If an individual is interested in study participation, a trained research assistant will lead
      the individual through the informed consent process in a private space.

      Since MORE is a closed group, the cohorts of 14 participants at each site will be randomized
      to TAU or MORE. Once 14 participants at a particular clinic are enrolled and randomized the
      MORE group will begin.

      Participants randomized to the MORE condition will participate in eight, weekly, two-hour
      group sessions, co-led by a clinic and study counselor. Each session will contain 7
      participants and take place remotely, by video conference. Attendance at each session and
      reasons for missing sessions will be recorded. Participants randomized to the control
      condition will continue receiving treatment as usual.

      All study participants will partake in a total of three interviews lasting up to 90 minutes
      and occurring, remotely, at baseline, 8- and 16- weeks post-baseline by telephone or video
      conference. Each participant will also complete a urine or saliva drug screen at each
      assessment. All attempts to reach participants to schedule follow-up assessments will be
      tracked. Participants will also complete cognitive testing (for approx. 30-45 minutes) at
      baseline and 8-weeks and ecological momentary assessments (EMA) conducted via smartphones or
      tablets, which will be provided to each participant by study staff. EMA participation will
      require the participant to respond to twice-daily prompts in which they will be asked a
      series of brief questions regarding their current mood and exposure to opioid triggers.
      Additionally, subjects will be asked to initiate responses when they experience serious
      craving or relapse to opioid use. Each EMA assessment will last approximately 3-5 minutes.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Two-arm randomized controlled trial.
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: Opioid relapse through 16-weeks.
time frame: 16-weeks
description: Number of days until first opioid use as measured by self-report through EMA, follow-back, or urine screen.
measure: Methadone treatment retention through 16-weeks.
time frame: 16-weeks
description: Number of days to methadone dosing lapse or discontinuation as measured by EMA, follow-back, clinic charts, or urine screen.
measure: Opioid abstinence versus any opioid use.
time frame: 8-weeks
description: Used opioids or not at 8-weeks as measured by self-report through EMA or timeline follow-back and verified by urine or saliva drug screen.
measure: Opioid abstinence versus any opioid use.
time frame: 16-weeks
description: Used opioids or not as measured by self-report through EMA or timeline follow-back and verified by urine or saliva drug screen.
measure: Other drug abstinence versus other drug use.
time frame: 8-weeks
description: Used other drugs or not as measured by self-report through EMA or timeline follow-back and verified by urine or saliva drug screen.
measure: Other drug abstinence versus other drug use.
time frame: 16-weeks
description: Uses other drugs or not as measured by self-report through EMA or timeline follow-back and verified by urine or saliva drug screen.
measure: Number of days of opioid use.
time frame: 8-weeks
description: Number of days of opioid use as measured by self-report through EMA or timeline follow-back and verified by urine or saliva drug screen.
measure: Number of days of opioid use.
time frame: 16-weeks
description: Number of days of opioid use as measured by self-report through EMA or timeline follow-back and verified by urine or saliva drug screen.
measure: Number of days of other drug use.
time frame: 16-weeks
description: Number of days of other drug use as measured by self-report through EMA or timeline follow-back and verified by urine or saliva drug screen.
measure: Craving level.
time frame: 8-weeks
description: Penn Alcohol Craving Scale score on a range from 0 (e.g., no craving) to 6 (intense craving) or EMA.
measure: Craving level.
time frame: 16-weeks
description: Penn Alcohol Craving Scale score on a range from 0 (e.g., no craving) to 6 (intense craving) or EMA .
measure: Pain level.
time frame: 8-weeks
description: Brief Pain Inventory score on a scale from 0 (no pain) to 10 (pain as bad as you can imagine) or EMA.
measure: Pain level.
time frame: 16-weeks
description: Brief Pain Inventory score on a scale from 0 (no pain) to 10 (pain as bad as you can imagine) or EMA.
measure: Emotional Distress
time frame: 8-weeks
description: Beck Anxiety Inventory score on a scale from 0 (no anxiety) to 63 (severe anxiety) and Center for Epidemiology Scale for Depression scored on a scale from 0 (no depression) to 60 (severe depression) or EMA.
measure: Emotional Distress
time frame: 16-weeks
description: Beck Anxiety Inventory score on a scale from 0 (no anxiety) to 63 (severe anxiety) and Center for Epidemiology Scale for Depression scored on a scale from 0 (no depression) to 60 (severe depression) or EMA.
measure: Positive Affect.
time frame: 8-weeks
description: Positive feelings on a scale from 0 (not at all positive) to 10 (very positive)
measure: Positive Affect.
time frame: 16-weeks.
description: Positive feelings on a scale from 0 (not at all positive) to 10 (very positive)
arm group label: Mindfulness Oriented Recovery Enhancement
arm group type: Experimental
description: The Mindfulness Oriented Recovery Enhancement arm will participate in eight, weekly, two-hour group sessions.MORE sessions involve mindfulness training to prevent opioid relapse and reduce pain, cognitive reappraisal to decrease negative affect and regulate opioid craving, and savoring to augment natural reward processing and evoke positive emotion. Each session begins with a mindful breathing meditation, followed by a debriefing session. The therapist then debriefs participants' homework practice of using mindfulness, reappraisal, and savoring skills to cope with pain and enhance well-being in everyday life. During this debrief of the homework. Next, new psychoeducational material is introduced. Sessions culminate with an experiential exercise, and close with a brief mindful breathing meditation. Participants are asked to practice 15 minutes of mindfulness/reappraisal/savoring skills each day.
arm group label: Methadone Treatment as Usual
arm group type: Other
description: In the methadone programs, clients typically come to the clinic regularly to get their methadone dose. Clients see their clinic substance abuse counselor for individual counseling, usually weekly at the beginning of treatment, with decreasing frequency if they remain abstinent and progress through treatment. Depending on clients' stage of MMT and success with remaining abstinent from drugs, they may be required to attend clinic treatment groups. Also, some clients may choose to go to voluntary counseling, educational, or support groups.
intervention type: Behavioral
intervention name: Mindfulness Oriented Recovery Enhancement
description: MORE sessions involve mindfulness training to prevent opioid relapse and reduce pain, cognitive reappraisal to decrease negative affect and regulate opioid craving, and savoring to augment natural reward processing and evoke positive emotion. Each session begins with a mindful breathing meditation, followed by a debriefing session. The therapist then debriefs participants' homework practice of using mindfulness, reappraisal, and savoring skills to cope with pain and enhance well-being in everyday life. During this debrief of the homework. Next, new psychoeducational material is introduced. Sessions culminate with an experiential exercise, and close with a brief mindful breathing meditation. Participants are asked to practice 15 minutes of mindfulness/reappraisal/savoring skills each day.
arm group label: Mindfulness Oriented Recovery Enhancement
other name: MORE
intervention type: Other
intervention name: Methadone Treatment as Usual
description: In the methadone programs, clients typically come to the clinic regularly to get their methadone dose. Clients see their clinic substance abuse counselor for individual counseling, usually weekly at the beginning of treatment, with decreasing frequency if they remain abstinent and progress through treatment. Depending on clients' stage of MMT and success with remaining abstinent from drugs, they may be required to attend clinic treatment groups. Also, some clients may choose to go to voluntary counseling, educational, or support groups.
arm group label: Methadone Treatment as Usual
other name: MMT, Treatment as Usual, TAU
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
facility: 
country: United States
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
mesh term: Chronic Pain
mesh term: Methadone
sharing ipd: Yes
ipd description: Analyses of data generated from this project will be shared with the scientific community through publications in peer-reviewed journals and presentations at scientific meetings. The proposed research will include data from approximately 154 individuals in methadone maintenance treatment. The final dataset will include self-reported demographic and behavioral data from interviews with the subjects and laboratory data from urine or saliva specimens provided. Because we will be following study participants, we will be collecting identifying information. The final dataset will be stripped of identifiers prior to release for sharing.
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: Beginning 3 months and ending 36 months after study publication.
ipd access criteria: Data and associated documentation will be available to research community scientists only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.
provided document: 