<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/NCT01684293</url>
  </required_header>
  <id_info>
    <org_study_id>5K23DA034883-02</org_study_id>
    <nct_id>NCT01684293</nct_id>
  </id_info>
  <brief_title>Occupational Therapy-Based Cognitive Rehabilitation of Cocaine Abusers: A Pilot Study</brief_title>
  <official_title>Occupational Therapy-Based Cognitive Rehabilitation of Cocaine Abusers: A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>San Francisco Veterans Affairs Medical Center</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, San Francisco</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study integrates a model of occupational-therapy based cognitive rehabilitation as part&#xD;
      of a comprehensive treatment plan for cocaine abusers. We hypothesize that cognitive&#xD;
      impairment and quality of life would improve and that cocaine use would decrease in those&#xD;
      participants receiving occupational-therapy based cognitive rehabilitation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      occupational-therapy based cognitive rehabilitation as part of a comprehensive treatment plan&#xD;
      for cocaine abusers&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2013</start_date>
  <completion_date type="Actual">March 31, 2019</completion_date>
  <primary_completion_date type="Actual">March 31, 2019</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 (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in cognitive impairment</measure>
    <time_frame>baseline through 6 months</time_frame>
    <description>Global Deficit Score, range 0 (no impairment) to 5 (severe impairment)</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Mild Cognitive Impairment, So Stated</condition>
  <condition>Cocaine Use Disorder</condition>
  <arm_group>
    <arm_group_label>Cognitive Rehabilitation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Occupational therapy-based cognitive rehabilitation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Psychoeducation/games</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Psychoeducation/games</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Occupational therapy-based cognitive rehabilitation</intervention_name>
    <description>Occupational therapy-based cognitive rehabilitation</description>
    <arm_group_label>Cognitive Rehabilitation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Psychoeducation/games</intervention_name>
    <description>Psychoeducation/games</description>
    <arm_group_label>Psychoeducation/games</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age 18-65&#xD;
&#xD;
          2. Primary cocaine use disorder (based on DSM-5 criteria) and in at least 3 months of&#xD;
             remission&#xD;
&#xD;
          3. At least mild cognitive impairment, defined as = or &gt; 1.5 standard deviations&#xD;
             impairment on any 2 performance-based neurocognitive measures&#xD;
&#xD;
          4. Needing to change quality of life, defined as self-identifying at least 2 life areas&#xD;
             as needing to change on the Drug User Quality of Life Scale&#xD;
&#xD;
          5. A Veteran at the San Francisco Veterans Affairs Medical Center&#xD;
&#xD;
          6. Currently receiving weekly drug counseling (individual or group; at least 1 hour/week)&#xD;
             through an outpatient substance use disorder treatment program&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Inability to speak, read, write, and understand English&#xD;
&#xD;
          2. Inadequate hearing or vision&#xD;
&#xD;
          3. Concurrent substance use disorder (except tobacco or caffeine) not in at least 3&#xD;
             months of remission&#xD;
&#xD;
          4. A psychiatric disorder that will interfere with study participation or will make&#xD;
             participation hazardous (e.g., psychosis, suicidal or homicidal ideations, severe&#xD;
             anxiety)&#xD;
&#xD;
          5. A depressive disorder classified as severe, defined as a Beck Depression Inventory-II&#xD;
             score &gt;29&#xD;
&#xD;
          6. Current diagnosis of a bipolar disorder needing acute inpatient psychiatric&#xD;
             hospitalization&#xD;
&#xD;
          7. Currently symptomatic from attention-deficit/hyperactivity disorder (DSM-5 criteria)&#xD;
&#xD;
          8. Any learning disorder, any type of dementia, any type of delirium, or an amnestic&#xD;
             disorder due to any general medical condition&#xD;
&#xD;
          9. Wechsler Test of Adult Reading standard score &lt;70&#xD;
&#xD;
         10. Mini-Mental State Examination score &lt;24&#xD;
&#xD;
         11. Current use of scheduled (i.e., prescribed) regular (i.e., daily) psychotropics or&#xD;
             other medicines with a high likelihood of sedation &amp; cognitive impairment (e.g.,&#xD;
             benzodiazepines, clozapine, anticholinergics)&#xD;
&#xD;
         12. Currently prescribed stimulants (e.g., methylphenidate) or cognitive enhancers (e.g.,&#xD;
             donepezil, memantine)&#xD;
&#xD;
         13. Active medical illnesses - uncontrolled diabetes, uncontrolled hypertension,&#xD;
             uncontrolled thyroid dysfunction, or uncontrolled B12/folate deficiency; central&#xD;
             nervous system illness with potential cognitive aspects (Parkinson's, or Huntington's&#xD;
             dementia); Cirrhosis with complications (e.g., ascites, encephalopathy, jaundice,&#xD;
             gastrointestinal bleeding); Needing acute medical hospitalization from HIV sequelae,&#xD;
             such as HIV-related opportunistic infection&#xD;
&#xD;
         14. Any history of any type of stroke or brain hemorrhage&#xD;
&#xD;
         15. Any history of traumatic brain injury, intracranial pathology (e.g., tumor), or brain&#xD;
             surgery&#xD;
&#xD;
         16. Currently on probation or parole&#xD;
&#xD;
         17. Concurrent participation in another study that medically/administratively interferes&#xD;
             with this study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Raj K Kalapatapu, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, San Francisco</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of California, San Francisco &amp; San Francisco Veterans Affairs Medical Center</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94121</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>September 10, 2012</study_first_submitted>
  <study_first_submitted_qc>September 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2012</study_first_posted>
  <last_update_submitted>June 28, 2019</last_update_submitted>
  <last_update_submitted_qc>June 28, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 1, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cocaine</keyword>
  <keyword>Cognitive Impairment</keyword>
  <keyword>Cognitive Rehabilitation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cognitive Dysfunction</mesh_term>
  </condition_browse>
  <!-- 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/NCT01684293
org study id: 5K23DA034883-02
nct id: NCT01684293
lead sponsor: 
collaborator: 
has dmc: Yes
This study integrates a model of occupational-therapy based cognitive rehabilitation as part
      of a comprehensive treatment plan for cocaine abusers. We hypothesize that cognitive
      impairment and quality of life would improve and that cocaine use would decrease in those
      participants receiving occupational-therapy based cognitive rehabilitation.
occupational-therapy based cognitive rehabilitation as part of a comprehensive treatment plan
      for cocaine abusers
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change in cognitive impairment
time frame: baseline through 6 months
description: Global Deficit Score, range 0 (no impairment) to 5 (severe impairment)
arm group label: Cognitive Rehabilitation
arm group type: Experimental
description: Occupational therapy-based cognitive rehabilitation
arm group label: Psychoeducation/games
arm group type: Placebo Comparator
description: Psychoeducation/games
intervention type: Behavioral
intervention name: Occupational therapy-based cognitive rehabilitation
description: Occupational therapy-based cognitive rehabilitation
arm group label: Cognitive Rehabilitation
intervention type: Behavioral
intervention name: Psychoeducation/games
description: Psychoeducation/games
arm group label: Psychoeducation/games
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Raj K Kalapatapu, MD
role: Principal Investigator
affiliation: University of California, San Francisco
facility: 
country: United States
responsible party type: Sponsor
mesh term: Cognitive Dysfunction