<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/NCT04433975</url>
  </required_header>
  <id_info>
    <org_study_id>HUM00166747</org_study_id>
    <secondary_id>R33AT010106</secondary_id>
    <secondary_id>R01AT010797</secondary_id>
    <nct_id>NCT04433975</nct_id>
  </id_info>
  <brief_title>Psychosocial Pain Management to Improve Opioid Use Disorder Treatment Outcomes</brief_title>
  <acronym>Persist</acronym>
  <official_title>Psychosocial Pain Management to Improve Opioid Use Disorder Treatment Outcomes: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Michigan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Center for Complementary and Integrative Health (NCCIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>US Department of Veterans Affairs</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Michigan</source>
  <oversight_info>
    <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 research study is to look at the effect of programs aimed at helping&#xD;
      people manage chronic pain and medication treatment. The program sessions focus on&#xD;
      educational information and strategies for pain and medication management. The researchers&#xD;
      enroll people who have chronic pain and have recently begun buprenorphine treatment to see if&#xD;
      participants could benefit from these programs. This research study will help the researchers&#xD;
      learn how to improve current therapies for pain and medication management.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 14, 2020</start_date>
  <completion_date type="Anticipated">August 2024</completion_date>
  <primary_completion_date type="Anticipated">August 2024</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>Supportive Care</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Retention on buprenorphine treatment according to TimeLine Follow-Back</measure>
    <time_frame>Up to 3-months post enrollment</time_frame>
    <description>Retention on buprenorphine treatment will be operationalized as time to first episode of buprenorphine treatment non-adherence. Non-adherence, or discontinuation of treatment, will be defined as a consecutive period of 7 or more calendar days without taking buprenorphine. Buprenorphine retention data will be collected as part of the TimeLine Follow-Back (TLFB) assessment, which will be administered at the baseline enrollment assessment and the 1- and 3-month follow-ups in which the participant will be asked to recall on which days they took their buprenorphine medications.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Retention on buprenorphine treatment according to TimeLine Follow-Back</measure>
    <time_frame>Up to 12-months post enrollment</time_frame>
    <description>Retention on buprenorphine treatment will be operationalized as time to first episode of buprenorphine treatment non-adherence. Non-adherence, or discontinuation of treatment, will be defined as a consecutive period of 7 or more calendar days without taking buprenorphine. Buprenorphine retention data will be collected as part of the TimeLine Follow-Back (TLFB) assessment, which will be administered at the baseline enrollment assessment and the 1-, 3-, 6-, 9-, and 12-month follow-ups in which the participant will be asked to recall on which days they took their buprenorphine medications.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in self-reported level of pain intensity on the Numerical Rating Scale for Pain Intensity (NRS-I).</measure>
    <time_frame>Up to 3-months post enrollment</time_frame>
    <description>Pain level will be measured using the Numerical Rating Scale for Pain Intensity (NRS-I), an 11-point numeric rating scale (0 = no pain, 10 = worst pain imaginable), which will be collected at the baseline enrollment assessment and the 1- and 3--month follow-ups. For each follow-up time point, we will subtract the baseline value to obtain a change score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in self-reported level of pain related functioning on the Brief Pain Inventory - Short Form (BPI)</measure>
    <time_frame>Up to 3-months post enrollment</time_frame>
    <description>Pain-related functioning will be measured using the pain interference subscale of the Brief Pain Inventory - Short Form (BPI). For this study, an increase in pain-related functioning will be operationalized as a reduction in the pain interference scale scores over time. The BPI interference subscale measures how much pain has interfered with seven daily activities and will provide a current level of pain-related functioning (past 24-hours) at each follow-up (1- and 3-months). BPI pain interference will be calculated as the mean of the seven interference items. For each follow-up time point, we will subtract the baseline value to obtain a change score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in self-reported level of pain related functioning on the Pain Interference measure</measure>
    <time_frame>Up to 3-months post enrollment</time_frame>
    <description>Pain-related functioning will be measured using the Pain Interference measure, which encompasses questions from Patient-Reported Outcomes Measurement Information System (PROMIS) Health Systems item bank v1.1. For this study, an increase in pain-related functioning will be operationalized as a reduction in the pain interference scale scores over time. The PROMIS Pain Interference item banks assess pain functioning over the past 7 days at each follow-up (1- and 3-months) and assesses consequences of pain on variables including the extent to which pain interferes with social, cognitive, emotional, physical, and recreational activities. This measure will be scored using an Item Response Theory (IRT) scoring metric. For each follow-up time point, we will subtract the baseline value to obtain a change score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent days abstinent from substance use on the TimeLine Follow-Back</measure>
    <time_frame>Up to 3-months post enrollment</time_frame>
    <description>Frequency of substance use will be measured using the TimeLine Follow-Back and will be collected at the baseline assessment and the 1- and 3-month follow-ups. During the administration, the participant will be asked to recall their alcohol and drug use utilizing a calendar-assisted structured interview that provides the participant with temporal cues to increase the accuracy of recall. At the baseline assessment, retrospective data will be collected for the 6-months prior to study enrollment. At each follow-up, data will be collected for the entire period since the previous date of data collection. Percent days abstinent from substances (e.g. alcohol and drugs) will be used as the primary measure of substance use.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in self-reported level of pain intensity on the Numerical Rating Scale for Pain Intensity (NRS-I).</measure>
    <time_frame>Up to 12-months post enrollment</time_frame>
    <description>Pain level will be measured using the Numerical Rating Scale for Pain Intensity (NRS-I), an 11-point numeric rating scale (0 = no pain, 10 = worst pain imaginable), which will be collected at the baseline enrollment assessment and the 1-, 3-, 6-, 9-, and 12-month follow-ups. For each follow-up time point, we will subtract the baseline value to obtain a change score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in self-reported level of pain related functioning on the Brief Pain Inventory - Short Form (BPI)</measure>
    <time_frame>Up to 12-months post enrollment</time_frame>
    <description>Pain-related functioning will be measured using the pain interference subscale of the Brief Pain Inventory - Short Form (BPI). For this study, an increase in pain-related functioning will be operationalized as a reduction in the pain interference scale scores over time. The BPI interference subscale measures how much pain has interfered with seven daily activities and will provide a current level of pain-related functioning (past 24-hours) at each follow-up (1-, 3-, 6-, 9-, and 12-months). BPI pain interference will be calculated as the mean of the seven interference items. For each follow-up time point, we will subtract the baseline value to obtain a change score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in self-reported level of pain related functioning on the Pain Interference measure</measure>
    <time_frame>Up to 12-months post enrollment</time_frame>
    <description>Pain-related functioning will be measured using the Pain Interference measure, which encompasses questions from Patient-Reported Outcomes Measurement Information System (PROMIS) Health Systems item bank v1.1. For this study, an increase in pain-related functioning will be operationalized as a reduction in the pain interference scale scores over time. The PROMIS Pain Interference item banks assess pain functioning over the past 7 days at each follow-up (1-, 3-, 6-, 9-, and 12-months) and assesses consequences of pain on variables including the extent to which pain interferes with social, cognitive, emotional, physical, and recreational activities. This measure will be scored using an Item Response Theory (IRT) scoring metric. For each follow-up time point, we will subtract the baseline value to obtain a change score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent days abstinent from substance use on the TimeLine Follow-Back</measure>
    <time_frame>Up to 12-months post enrollment</time_frame>
    <description>Frequency of substance use will be measured using the TimeLine Follow-Back and will be collected at the baseline assessment and the 1-, 3-, 6-, 9-, and 12-month follow-ups. During the administration, the participant will be asked to recall their alcohol and drug use utilizing a calendar-assisted structured interview that provides the participant with temporal cues to increase the accuracy of recall. At the baseline assessment, retrospective data will be collected for the 6-months prior to study enrollment. At each follow-up, data will be collected for the entire period since the previous date of data collection. Percent days abstinent from substances (e.g. alcohol and drugs) will be used as the primary measure of substance use.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Opioid-use Disorder</condition>
  <condition>Medication Assisted Treatment</condition>
  <condition>Chronic Pain</condition>
  <arm_group>
    <arm_group_label>Psychosocial Pain Management (PPMI)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Eight Cognitive Behavioral Therapy-based individual telephone or video therapy sessions with research study therapist.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Enhanced Usual Care (EUC)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Two individual telephone educational sessions with research study therapist.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Psychosocial Pain Management (PPMI)</intervention_name>
    <description>The main theme of the treatment is to provide participants with new ways of thinking and coping skills related to managing pain and opioid use in order to increase the likelihood the participant may remain in buprenorphine treatment.</description>
    <arm_group_label>Psychosocial Pain Management (PPMI)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Enhanced Usual Care (EUC)</intervention_name>
    <description>The EUC condition is designed to match the PPMI condition in terms of the non-specific aspects of receiving support for pain, substance use, and receiving monitoring of buprenorphine adherence.</description>
    <arm_group_label>Enhanced Usual Care (EUC)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  having a diagnosis of an opioid use disorders (OUD) within the past 12 months;&#xD;
&#xD;
          -  started buprenorphine (the term we use to refer to all buprenorphine products&#xD;
             including buprenorphine/naloxone) treatment within the past 6 months&#xD;
&#xD;
          -  at least moderate or greater self-reported pain on average over the past 3 months;&#xD;
&#xD;
          -  regular and consistent access to a telephone and willingness to use the phone for&#xD;
             study sessions.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  buprenorphine medication prescribed in the form of a monthly injection and/or a&#xD;
             transdermal patch&#xD;
&#xD;
          -  self-reported pregnancy at the time of study enrollment&#xD;
&#xD;
          -  currently living outside of the United States&#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>Allison Lin, M.D., M.S.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Michigan</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mark Ilgen, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Michigan</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mandy Lewis, MS</last_name>
    <phone>734-474-0702</phone>
    <email>mstinchc@med.umich.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Veterans Affair Ann Arbor Healthcare System</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48105</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mandy Lewis, MS</last_name>
      <phone>734-474-0702</phone>
      <email>mandy.lewis1@va.gov</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Michigan Medicine</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mandy Lewis, MS</last_name>
      <phone>734-936-1386</phone>
      <email>mstinchc@med.umich.edu</email>
    </contact>
    <investigator>
      <last_name>Mark Ilgen, Ph.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>June 12, 2020</study_first_submitted>
  <study_first_submitted_qc>June 12, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>March 30, 2023</last_update_submitted>
  <last_update_submitted_qc>March 30, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 31, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Michigan</investigator_affiliation>
    <investigator_full_name>Mark A. Ilgen</investigator_full_name>
    <investigator_title>Professor of Psychiatry</investigator_title>
  </responsible_party>
  <keyword>Psychosocial Pain Management</keyword>
  <keyword>Buprenorphine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chronic Pain</mesh_term>
    <mesh_term>Opioid-Related Disorders</mesh_term>
    <mesh_term>Substance-Related Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04433975
org study id: HUM00166747
secondary id: R33AT010106
secondary id: R01AT010797
nct id: NCT04433975
lead sponsor: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this research study is to look at the effect of programs aimed at helping
      people manage chronic pain and medication treatment. The program sessions focus on
      educational information and strategies for pain and medication management. The researchers
      enroll people who have chronic pain and have recently begun buprenorphine treatment to see if
      participants could benefit from these programs. This research study will help the researchers
      learn how to improve current therapies for pain and medication management.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
measure: Retention on buprenorphine treatment according to TimeLine Follow-Back
time frame: Up to 3-months post enrollment
description: Retention on buprenorphine treatment will be operationalized as time to first episode of buprenorphine treatment non-adherence. Non-adherence, or discontinuation of treatment, will be defined as a consecutive period of 7 or more calendar days without taking buprenorphine. Buprenorphine retention data will be collected as part of the TimeLine Follow-Back (TLFB) assessment, which will be administered at the baseline enrollment assessment and the 1- and 3-month follow-ups in which the participant will be asked to recall on which days they took their buprenorphine medications.
measure: Retention on buprenorphine treatment according to TimeLine Follow-Back
time frame: Up to 12-months post enrollment
description: Retention on buprenorphine treatment will be operationalized as time to first episode of buprenorphine treatment non-adherence. Non-adherence, or discontinuation of treatment, will be defined as a consecutive period of 7 or more calendar days without taking buprenorphine. Buprenorphine retention data will be collected as part of the TimeLine Follow-Back (TLFB) assessment, which will be administered at the baseline enrollment assessment and the 1-, 3-, 6-, 9-, and 12-month follow-ups in which the participant will be asked to recall on which days they took their buprenorphine medications.
measure: Change from baseline in self-reported level of pain intensity on the Numerical Rating Scale for Pain Intensity (NRS-I).
time frame: Up to 3-months post enrollment
description: Pain level will be measured using the Numerical Rating Scale for Pain Intensity (NRS-I), an 11-point numeric rating scale (0 = no pain, 10 = worst pain imaginable), which will be collected at the baseline enrollment assessment and the 1- and 3--month follow-ups. For each follow-up time point, we will subtract the baseline value to obtain a change score.
measure: Change from baseline in self-reported level of pain related functioning on the Brief Pain Inventory - Short Form (BPI)
time frame: Up to 3-months post enrollment
description: Pain-related functioning will be measured using the pain interference subscale of the Brief Pain Inventory - Short Form (BPI). For this study, an increase in pain-related functioning will be operationalized as a reduction in the pain interference scale scores over time. The BPI interference subscale measures how much pain has interfered with seven daily activities and will provide a current level of pain-related functioning (past 24-hours) at each follow-up (1- and 3-months). BPI pain interference will be calculated as the mean of the seven interference items. For each follow-up time point, we will subtract the baseline value to obtain a change score.
measure: Change from baseline in self-reported level of pain related functioning on the Pain Interference measure
time frame: Up to 3-months post enrollment
description: Pain-related functioning will be measured using the Pain Interference measure, which encompasses questions from Patient-Reported Outcomes Measurement Information System (PROMIS) Health Systems item bank v1.1. For this study, an increase in pain-related functioning will be operationalized as a reduction in the pain interference scale scores over time. The PROMIS Pain Interference item banks assess pain functioning over the past 7 days at each follow-up (1- and 3-months) and assesses consequences of pain on variables including the extent to which pain interferes with social, cognitive, emotional, physical, and recreational activities. This measure will be scored using an Item Response Theory (IRT) scoring metric. For each follow-up time point, we will subtract the baseline value to obtain a change score.
measure: Percent days abstinent from substance use on the TimeLine Follow-Back
time frame: Up to 3-months post enrollment
description: Frequency of substance use will be measured using the TimeLine Follow-Back and will be collected at the baseline assessment and the 1- and 3-month follow-ups. During the administration, the participant will be asked to recall their alcohol and drug use utilizing a calendar-assisted structured interview that provides the participant with temporal cues to increase the accuracy of recall. At the baseline assessment, retrospective data will be collected for the 6-months prior to study enrollment. At each follow-up, data will be collected for the entire period since the previous date of data collection. Percent days abstinent from substances (e.g. alcohol and drugs) will be used as the primary measure of substance use.
measure: Change from baseline in self-reported level of pain intensity on the Numerical Rating Scale for Pain Intensity (NRS-I).
time frame: Up to 12-months post enrollment
description: Pain level will be measured using the Numerical Rating Scale for Pain Intensity (NRS-I), an 11-point numeric rating scale (0 = no pain, 10 = worst pain imaginable), which will be collected at the baseline enrollment assessment and the 1-, 3-, 6-, 9-, and 12-month follow-ups. For each follow-up time point, we will subtract the baseline value to obtain a change score.
measure: Change from baseline in self-reported level of pain related functioning on the Brief Pain Inventory - Short Form (BPI)
time frame: Up to 12-months post enrollment
description: Pain-related functioning will be measured using the pain interference subscale of the Brief Pain Inventory - Short Form (BPI). For this study, an increase in pain-related functioning will be operationalized as a reduction in the pain interference scale scores over time. The BPI interference subscale measures how much pain has interfered with seven daily activities and will provide a current level of pain-related functioning (past 24-hours) at each follow-up (1-, 3-, 6-, 9-, and 12-months). BPI pain interference will be calculated as the mean of the seven interference items. For each follow-up time point, we will subtract the baseline value to obtain a change score.
measure: Change from baseline in self-reported level of pain related functioning on the Pain Interference measure
time frame: Up to 12-months post enrollment
description: Pain-related functioning will be measured using the Pain Interference measure, which encompasses questions from Patient-Reported Outcomes Measurement Information System (PROMIS) Health Systems item bank v1.1. For this study, an increase in pain-related functioning will be operationalized as a reduction in the pain interference scale scores over time. The PROMIS Pain Interference item banks assess pain functioning over the past 7 days at each follow-up (1-, 3-, 6-, 9-, and 12-months) and assesses consequences of pain on variables including the extent to which pain interferes with social, cognitive, emotional, physical, and recreational activities. This measure will be scored using an Item Response Theory (IRT) scoring metric. For each follow-up time point, we will subtract the baseline value to obtain a change score.
measure: Percent days abstinent from substance use on the TimeLine Follow-Back
time frame: Up to 12-months post enrollment
description: Frequency of substance use will be measured using the TimeLine Follow-Back and will be collected at the baseline assessment and the 1-, 3-, 6-, 9-, and 12-month follow-ups. During the administration, the participant will be asked to recall their alcohol and drug use utilizing a calendar-assisted structured interview that provides the participant with temporal cues to increase the accuracy of recall. At the baseline assessment, retrospective data will be collected for the 6-months prior to study enrollment. At each follow-up, data will be collected for the entire period since the previous date of data collection. Percent days abstinent from substances (e.g. alcohol and drugs) will be used as the primary measure of substance use.
arm group label: Psychosocial Pain Management (PPMI)
arm group type: Experimental
description: Eight Cognitive Behavioral Therapy-based individual telephone or video therapy sessions with research study therapist.
arm group label: Enhanced Usual Care (EUC)
arm group type: Active Comparator
description: Two individual telephone educational sessions with research study therapist.
intervention type: Behavioral
intervention name: Psychosocial Pain Management (PPMI)
description: The main theme of the treatment is to provide participants with new ways of thinking and coping skills related to managing pain and opioid use in order to increase the likelihood the participant may remain in buprenorphine treatment.
arm group label: Psychosocial Pain Management (PPMI)
intervention type: Behavioral
intervention name: Enhanced Usual Care (EUC)
description: The EUC condition is designed to match the PPMI condition in terms of the non-specific aspects of receiving support for pain, substance use, and receiving monitoring of buprenorphine adherence.
arm group label: Enhanced Usual Care (EUC)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Allison Lin, M.D., M.S.
role: Principal Investigator
affiliation: University of Michigan
last name: Mark Ilgen, Ph.D.
role: Principal Investigator
affiliation: University of Michigan
last name: Mandy Lewis, MS
phone: 734-474-0702
email: mstinchc@med.umich.edu
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Michigan
investigator full name: Mark A. Ilgen
investigator title: Professor of Psychiatry
mesh term: Chronic Pain
mesh term: Opioid-Related Disorders
mesh term: Substance-Related Disorders
sharing ipd: No