<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/NCT04436926</url>
  </required_header>
  <id_info>
    <org_study_id>19-29607</org_study_id>
    <nct_id>NCT04436926</nct_id>
  </id_info>
  <brief_title>Opioid Approach Bias Modification</brief_title>
  <acronym>OABM</acronym>
  <official_title>The Neural Basis of Approach Bias Modification in Opioid Users With Chronic Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, San Francisco</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>
      To investigate the neurobiological mechanisms underlying opioid approach bias during a pilot&#xD;
      RCT of opioid approach bias modification. The investigators are combining novel ultra-high&#xD;
      field MRI technology with the promising treatment of modifying cognitive bias away from&#xD;
      detrimental prescription drug use will generate novel neural data and potentially yield a new&#xD;
      therapeutic tool to reduce problematic opioid use.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The proposed study is a pilot prospective, parallel groups, randomized, double blind, sham&#xD;
      training-controlled, 6-session (over 2 weeks) clinical trial of opioid approach bias&#xD;
      modification (OABM) in 20 male and female veterans with chronic pain at high risk for&#xD;
      opioid-related adverse events at the San Francisco Veterans Affairs Health Care System,&#xD;
      between ages 18-69. The study consists of screening, 2-week cognitive training, Week-3&#xD;
      post-assessment. Assessment of the neurobiological mechanisms of opioid approach bias will be&#xD;
      administered at baseline and Week-3.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 1, 2021</start_date>
  <completion_date type="Anticipated">June 30, 2024</completion_date>
  <primary_completion_date type="Anticipated">June 30, 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>Other</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in reaction time on an opioid approach-avoidance task across time, baseline to end of treatment, week 3</measure>
    <time_frame>baseline to end of treatment, week 3</time_frame>
    <description>millisecond reaction time of (opioid push - opioid pull) - (non-opioid push - opioid pull) on an opioid approach-avoidance task where participants are asked to respond to the format of presented pictures, irregardless of the content. There are two categories of pictures; 20 different opioid pictures and 20 different non-opioid pictures, with two-hundred trials. Millisecond reaction time will be measured at baseline, prior to each training session during the 2-week training period, and at week 3 post training assessment. Primary outcome is change in reaction time across time in active vs. sham condition.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Opioid Use</condition>
  <condition>Chronic Pain</condition>
  <arm_group>
    <arm_group_label>opioid approach bias training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Immediately following screening, patients will be randomly assigned to receive 6 sessions of opioid approach bias modification taking place over two weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>sham training</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Immediately following screening, patients will be randomly assigned to receive 6 sessions of sham training taking place over two weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>opioid approach bias modification</intervention_name>
    <description>The investigators will use a training version of the Approach-Avoidance Task (AAT), in which patients are asked to respond to the format of presented pictures, irrespective of the pictures' content. Pushing a presented picture away will decrease picture size, whereas pulling a picture closer will increase size. There are 2 categories of pictures; 20 different opioid and 20 different non-medication alternative pain managing activities. Training effect is achieved by presenting opioid pictures in push format only and non-opioid pictures in pull format only. Two hundred training trials are presented per session.</description>
    <arm_group_label>opioid approach bias training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>sham training</intervention_name>
    <description>Sham training is identical to opioid approach bias training, except pictures are presented randomly in both formats.</description>
    <arm_group_label>sham training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and female veterans eligible for VA services&#xD;
&#xD;
          -  Ages 18-69&#xD;
&#xD;
          -  Chronic pain (current pain lasting ≥ 90 days)&#xD;
&#xD;
          -  Prescribed chronic opioids (≥ 90 days in past year)&#xD;
&#xD;
          -  High risk for opioid-related averse outcomes (≥ 20mg morphine equivalent daily dose).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Psychotic, bipolar disorders or other psychiatric disorders judged to be unstable by&#xD;
             the PI&#xD;
&#xD;
          -  Current or past history of the following: intrinsic cerebral tumors, cerebrovascular&#xD;
             accident/disease, brain aneurysm, arteriovenous malformations, surgical implantation&#xD;
             of neurostimulators or cardiac pacemakers, demyelinating and neurodegenerative&#xD;
             diseases, penetrating traumatic brain injury, and any other MRI contraindications.&#xD;
&#xD;
          -  No female participant will be pregnant or actively attempting to conceive to prevent&#xD;
             any unnecessary exposure to high magnetic fields or radio frequency energy to the&#xD;
             unborn child.&#xD;
&#xD;
          -  Concurrent participation in a treatment study&#xD;
&#xD;
          -  Moderately Severe/Severe withdrawal from opioids based on a score of 25 or more on the&#xD;
             Clinical Opiate Withdrawal Scale (COWS)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>69 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Steven Batki, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, San Francisco</affiliation>
  </overall_official>
  <overall_official>
    <last_name>David Pennington, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, San Francisco</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Brooke L Lasher</last_name>
    <phone>415-221-4810</phone>
    <phone_ext>24495</phone_ext>
    <email>brooke.lasher@va.gov</email>
  </overall_contact>
  <location>
    <facility>
      <name>VA Medical Center San Francisco</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94121</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>David L Pennington, PhD</last_name>
      <phone>415-221-4810</phone>
      <phone_ext>24504</phone_ext>
      <email>david.pennington2@va.gov</email>
    </contact>
    <contact_backup>
      <last_name>Brooke Lasher, BA</last_name>
      <phone>4152214810</phone>
      <phone_ext>24495</phone_ext>
      <email>brooke.lasher@va.gov</email>
    </contact_backup>
    <investigator>
      <last_name>Steven L Batki, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>June 16, 2020</study_first_submitted>
  <study_first_submitted_qc>June 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <last_update_submitted>June 9, 2023</last_update_submitted>
  <last_update_submitted_qc>June 9, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>opioid</keyword>
  <keyword>approach bias</keyword>
  <keyword>chronic pain</keyword>
  <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>Analgesics, Opioid</mesh_term>
  </intervention_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/NCT04436926
org study id: 19-29607
nct id: NCT04436926
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To investigate the neurobiological mechanisms underlying opioid approach bias during a pilot
      RCT of opioid approach bias modification. The investigators are combining novel ultra-high
      field MRI technology with the promising treatment of modifying cognitive bias away from
      detrimental prescription drug use will generate novel neural data and potentially yield a new
      therapeutic tool to reduce problematic opioid use.
The proposed study is a pilot prospective, parallel groups, randomized, double blind, sham
      training-controlled, 6-session (over 2 weeks) clinical trial of opioid approach bias
      modification (OABM) in 20 male and female veterans with chronic pain at high risk for
      opioid-related adverse events at the San Francisco Veterans Affairs Health Care System,
      between ages 18-69. The study consists of screening, 2-week cognitive training, Week-3
      post-assessment. Assessment of the neurobiological mechanisms of opioid approach bias will be
      administered at baseline and Week-3.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Double (Participant, Investigator)
measure: Change in reaction time on an opioid approach-avoidance task across time, baseline to end of treatment, week 3
time frame: baseline to end of treatment, week 3
description: millisecond reaction time of (opioid push - opioid pull) - (non-opioid push - opioid pull) on an opioid approach-avoidance task where participants are asked to respond to the format of presented pictures, irregardless of the content. There are two categories of pictures; 20 different opioid pictures and 20 different non-opioid pictures, with two-hundred trials. Millisecond reaction time will be measured at baseline, prior to each training session during the 2-week training period, and at week 3 post training assessment. Primary outcome is change in reaction time across time in active vs. sham condition.
arm group label: opioid approach bias training
arm group type: Experimental
description: Immediately following screening, patients will be randomly assigned to receive 6 sessions of opioid approach bias modification taking place over two weeks.
arm group label: sham training
arm group type: Sham Comparator
description: Immediately following screening, patients will be randomly assigned to receive 6 sessions of sham training taking place over two weeks.
intervention type: Behavioral
intervention name: opioid approach bias modification
description: The investigators will use a training version of the Approach-Avoidance Task (AAT), in which patients are asked to respond to the format of presented pictures, irrespective of the pictures' content. Pushing a presented picture away will decrease picture size, whereas pulling a picture closer will increase size. There are 2 categories of pictures; 20 different opioid and 20 different non-medication alternative pain managing activities. Training effect is achieved by presenting opioid pictures in push format only and non-opioid pictures in pull format only. Two hundred training trials are presented per session.
arm group label: opioid approach bias training
intervention type: Behavioral
intervention name: sham training
description: Sham training is identical to opioid approach bias training, except pictures are presented randomly in both formats.
arm group label: sham training
criteria: 
gender: All
minimum age: 18 Years
maximum age: 69 Years
healthy volunteers: No
last name: Steven Batki, MD
role: Principal Investigator
affiliation: University of California, San Francisco
last name: David Pennington, PhD
role: Principal Investigator
affiliation: University of California, San Francisco
last name: Brooke L Lasher
phone: 415-221-4810
phone ext: 24495
email: brooke.lasher@va.gov
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Chronic Pain
mesh term: Analgesics, Opioid
sharing ipd: No