<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/NCT04404348</url>
  </required_header>
  <id_info>
    <org_study_id>2018043</org_study_id>
    <nct_id>NCT04404348</nct_id>
  </id_info>
  <brief_title>Cognitive Rehabilitation for Opioid Abuse-related Cognitive Impairment</brief_title>
  <official_title>Cognitive Rehabilitation for Opioid Abuse-related Cognitive Impairment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oklahoma State University Center for Health Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Oklahoma State University Center for Health Sciences</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>
      Research has consistently found that cognitive impairment is common in persons with a history&#xD;
      of substance abuse. The most commonly identified impairments across all substances are in&#xD;
      attentional and working memory functioning and executive functioning; opioid-specific&#xD;
      research finds that memory is an additional area of common impairment. Initial research in&#xD;
      applying cognitive rehabilitation methods to substance abuse have shown it to be helpful&#xD;
      overall.&#xD;
&#xD;
      To develop a cognitive rehabilitation intervention that is effective for opioid abuse, this&#xD;
      study will adapt a cognitive training program that has been shown to be effective in other&#xD;
      patient groups. Patients in a residential opioid-abuse treatment program will undergo a&#xD;
      cognitive evaluation and then be assigned to receive the 4-week cognitive intervention or the&#xD;
      4-week placebo control arm. It is expected that the intervention group will show greater&#xD;
      gains on the cognitive post test and will have higher rated treatment adherence and opioid&#xD;
      treatment program completion rates.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Suspended</overall_status>
  <why_stopped>
    Study halted due to Covid-19 precautions&#xD;
  </why_stopped>
  <start_date type="Actual">March 6, 2020</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">December 2020</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>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean Cognitive Change from Baseline to Endpoint</measure>
    <time_frame>Post-intervention at week 4</time_frame>
    <description>Change in overall cognitive summary score from pretest to posttest on NIH Toolbox.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Substance Abuse Program Completion Rate</measure>
    <time_frame>Until treatment program discharge, usually 30-45 days</time_frame>
    <description>Completion rate of recommended treatment program length, quantified as percentage completed</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Substance-Related Disorders</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Three times per week for four weeks, participants will complete a computerized cognitive training session (approximately 30 minutes long).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Three times per week for four weeks, participants will complete a computerized session (approximately 30 minutes long) that consists of inert computer games.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitive Training</intervention_name>
    <description>Exercises used will be: Mind Bender, Divided Attention, Freeze Frame, Mixed Signals, Target Tracker, To Do List.</description>
    <arm_group_label>Intervention</arm_group_label>
    <other_name>Posit Science-Brain HQ</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Placebo Control</intervention_name>
    <description>Games are drawn from the set of research control games provided by Posit Science-Brain HQ.</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Has completed the detoxification process&#xD;
&#xD;
          -  Has completed at least 8 years of formal education&#xD;
&#xD;
          -  Speaks and reads English fluently&#xD;
&#xD;
          -  Is beginning residential inpatient treatment for opioid abuse (note: may be receiving&#xD;
             treatment for polysubstance abuse but opioid must be one of their regular drugs of&#xD;
             abuse)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to self-consent (has a proxy for medical decision-making, legal guardian, or&#xD;
             been otherwise determined unable to give consent)&#xD;
&#xD;
          -  Past diagnosis or suspected current diagnosis of a neurodevelopmental disorder (e.g.,&#xD;
             autism, learning disability), attention-deficit disorder, or neurocognitive disorder&#xD;
             (e.g., dementia)&#xD;
&#xD;
          -  History of major head trauma (defined as loss of consciousness for 30 minutes or&#xD;
             longer) or brain surgery. (Note: History of concussion, including brief loss of&#xD;
             consciousness, is okay)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alicia Ford, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Oklahoma State University Center for Health Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>12&amp;12, Inc</name>
      <address>
        <city>Tulsa</city>
        <state>Oklahoma</state>
        <zip>74135</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>March 9, 2020</study_first_submitted>
  <study_first_submitted_qc>May 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <last_update_submitted>September 17, 2020</last_update_submitted>
  <last_update_submitted_qc>September 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Substance-Related Disorders</mesh_term>
    <mesh_term>Opioid-Related Disorders</mesh_term>
    <mesh_term>Cognitive Dysfunction</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/NCT04404348
org study id: 2018043
nct id: NCT04404348
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Research has consistently found that cognitive impairment is common in persons with a history
      of substance abuse. The most commonly identified impairments across all substances are in
      attentional and working memory functioning and executive functioning; opioid-specific
      research finds that memory is an additional area of common impairment. Initial research in
      applying cognitive rehabilitation methods to substance abuse have shown it to be helpful
      overall.

      To develop a cognitive rehabilitation intervention that is effective for opioid abuse, this
      study will adapt a cognitive training program that has been shown to be effective in other
      patient groups. Patients in a residential opioid-abuse treatment program will undergo a
      cognitive evaluation and then be assigned to receive the 4-week cognitive intervention or the
      4-week placebo control arm. It is expected that the intervention group will show greater
      gains on the cognitive post test and will have higher rated treatment adherence and opioid
      treatment program completion rates.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Mean Cognitive Change from Baseline to Endpoint
time frame: Post-intervention at week 4
description: Change in overall cognitive summary score from pretest to posttest on NIH Toolbox.
measure: Substance Abuse Program Completion Rate
time frame: Until treatment program discharge, usually 30-45 days
description: Completion rate of recommended treatment program length, quantified as percentage completed
arm group label: Intervention
arm group type: Experimental
description: Three times per week for four weeks, participants will complete a computerized cognitive training session (approximately 30 minutes long).
arm group label: Control
arm group type: Placebo Comparator
description: Three times per week for four weeks, participants will complete a computerized session (approximately 30 minutes long) that consists of inert computer games.
intervention type: Behavioral
intervention name: Cognitive Training
description: Exercises used will be: Mind Bender, Divided Attention, Freeze Frame, Mixed Signals, Target Tracker, To Do List.
arm group label: Intervention
other name: Posit Science-Brain HQ
intervention type: Behavioral
intervention name: Placebo Control
description: Games are drawn from the set of research control games provided by Posit Science-Brain HQ.
arm group label: Control
criteria: 
gender: All
minimum age: 18 Years
maximum age: 64 Years
healthy volunteers: No
last name: Alicia Ford, PhD
role: Principal Investigator
affiliation: Oklahoma State University Center for Health Sciences
facility: 
country: United States
responsible party type: Sponsor
mesh term: Substance-Related Disorders
mesh term: Opioid-Related Disorders
mesh term: Cognitive Dysfunction
sharing ipd: No