<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/NCT03013478</url>
  </required_header>
  <id_info>
    <org_study_id>1607018152</org_study_id>
    <secondary_id>R01DA030369</secondary_id>
    <nct_id>NCT03013478</nct_id>
  </id_info>
  <brief_title>Computer Based Training in CBT in Primary Care</brief_title>
  <official_title>Computer Based Training in CBT in Primary Care</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yale University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Drug Abuse (NIDA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Yale University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To conduct an 8-week randomized trial evaluating the feasibility and efficacy of adding&#xD;
      CBT4CBT to treatment as usual in a community based primary care program in a population of 60&#xD;
      individuals who meet current DSM criteria for substance use disorder other than nicotine.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators will conduct an initial evaluation of the computer program as an&#xD;
      enhancement of treatment as usual in a community-based primary care clinic. Sixty individuals&#xD;
      with a current DSM-IV alcohol or substance use disorder will be randomly assigned to either&#xD;
      (1) treatment as usual, or (2) treatment as usual plus exposure to the 'CBT for CBT' program&#xD;
      over a period of 8 weeks. Primary outcomes will be retention in treatment and reduction in&#xD;
      drug use over 8 weeks. Secondary outcomes include treatment utilization&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2016</start_date>
  <completion_date type="Actual">August 31, 2018</completion_date>
  <primary_completion_date type="Actual">August 31, 2018</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>retention in treatment</measure>
    <time_frame>0 - 8 weeks</time_frame>
    <description>subjects returning for treatment at primary care unit and completing CBT4CBT program for those assigned</description>
  </primary_outcome>
  <primary_outcome>
    <measure>reduction in drug use</measure>
    <time_frame>0 - 8 weeks</time_frame>
    <description>Using urine and breathalyzer screening for negative drug and alcohol testing</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">58</enrollment>
  <condition>Substance Abuse</condition>
  <arm_group>
    <arm_group_label>Standard treatment as usual (TAU)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Treatment normally offered at this primary care clinic</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TAU plus CBT4CBT program</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Treatment normally offered at this clinic PLUS 8 weeks of CBT4CBT computerized therapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Standard Treatment As Usual (TAU)</intervention_name>
    <description>Treatment normally offered at this primary care clinic</description>
    <arm_group_label>TAU plus CBT4CBT program</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>CBT4CBT program</intervention_name>
    <arm_group_label>TAU plus CBT4CBT program</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Are 18 years of age or older.&#xD;
&#xD;
          -  Are applying for outpatient substance abuse treatment&#xD;
&#xD;
          -  Meet current DSM-IV criteria for cocaine, marijuana, opioid, alcohol or other&#xD;
             stimulant use disorder&#xD;
&#xD;
          -  Are sufficiently stable for 8 weeks of outpatient treatment&#xD;
&#xD;
          -  Can commit to 8 weeks of treatment and are willing to be randomized to treatment&#xD;
&#xD;
          -  Are willing to provide locator information.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have an untreated bipolar or schizophrenic disorder&#xD;
&#xD;
          -  Have a current legal case pending such that incarceration during the 8 week protocol&#xD;
             is likely&#xD;
&#xD;
          -  Are in need of detoxification from alcohol, opioids or benzodiazepines&#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>Kathleen M Carroll, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yale University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Yale New Haven Hospital St Raphael's Campus</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06604</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>January 4, 2017</study_first_submitted>
  <study_first_submitted_qc>January 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 6, 2017</study_first_posted>
  <last_update_submitted>September 11, 2018</last_update_submitted>
  <last_update_submitted_qc>September 11, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 12, 2018</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>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</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/NCT03013478
org study id: 1607018152
secondary id: R01DA030369
nct id: NCT03013478
lead sponsor: 
collaborator: 
has dmc: Yes
To conduct an 8-week randomized trial evaluating the feasibility and efficacy of adding
      CBT4CBT to treatment as usual in a community based primary care program in a population of 60
      individuals who meet current DSM criteria for substance use disorder other than nicotine.
The investigators will conduct an initial evaluation of the computer program as an
      enhancement of treatment as usual in a community-based primary care clinic. Sixty individuals
      with a current DSM-IV alcohol or substance use disorder will be randomly assigned to either
      (1) treatment as usual, or (2) treatment as usual plus exposure to the 'CBT for CBT' program
      over a period of 8 weeks. Primary outcomes will be retention in treatment and reduction in
      drug use over 8 weeks. Secondary outcomes include treatment utilization
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: retention in treatment
time frame: 0 - 8 weeks
description: subjects returning for treatment at primary care unit and completing CBT4CBT program for those assigned
measure: reduction in drug use
time frame: 0 - 8 weeks
description: Using urine and breathalyzer screening for negative drug and alcohol testing
arm group label: Standard treatment as usual (TAU)
arm group type: No Intervention
description: Treatment normally offered at this primary care clinic
arm group label: TAU plus CBT4CBT program
arm group type: Active Comparator
description: Treatment normally offered at this clinic PLUS 8 weeks of CBT4CBT computerized therapy.
intervention type: Behavioral
intervention name: Standard Treatment As Usual (TAU)
description: Treatment normally offered at this primary care clinic
arm group label: TAU plus CBT4CBT program
intervention type: Behavioral
intervention name: CBT4CBT program
arm group label: TAU plus CBT4CBT program
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Kathleen M Carroll, PhD
role: Principal Investigator
affiliation: Yale University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Substance-Related Disorders
sharing ipd: Yes