<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/NCT03758274</url>
  </required_header>
  <id_info>
    <org_study_id>RSRB00072850</org_study_id>
    <nct_id>NCT03758274</nct_id>
  </id_info>
  <brief_title>Talk Therapy by Phone to Promote Treatment for Alcohol Problems</brief_title>
  <official_title>Cognitive Behavioral Treatment by Phone to Promote Use of Alcohol Related Care and Reduce Drinking</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Rochester</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>Medical University of South Carolina</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Syracuse University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Rochester</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>
      A small percentage of individuals with alcohol use disorder (AUD) obtain alcohol-related care&#xD;
      despite research showing that treatment is effective. This randomized controlled trial tests&#xD;
      the efficacy of a brief, phone based cognitive behavioral intervention to increase treatment&#xD;
      engagement, improve alcohol related outcomes, and show that treatment engagement is a&#xD;
      mechanism for the improved outcomes in individuals with AUD.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2019</start_date>
  <completion_date type="Actual">July 21, 2022</completion_date>
  <primary_completion_date type="Actual">July 21, 2022</primary_completion_date>
  <phase>Phase 2</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>Average drinks per drinking day</measure>
    <time_frame>30 days</time_frame>
    <description>Average number of standard drinks on days of alcohol consumption</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percent days abstinent</measure>
    <time_frame>30 days</time_frame>
    <description>Percentage of days abstinent from alcohol</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number Initiating Alcohol Use Disorder Treatment</measure>
    <time_frame>30 days</time_frame>
    <description>Attendance at Alcohol Use Disorder Treatment</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">400</enrollment>
  <condition>Alcohol Use Disorder</condition>
  <condition>Alcohol Abuse</condition>
  <arm_group>
    <arm_group_label>CBT Phone Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Being Read A Pamphlet on Alcohol Treatment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>CBT by Phone to Promote Treatment</intervention_name>
    <description>Structured phone intervention to identify concerns about getting alcohol use disorder treatment and to work through those concerns using cognitive behavioral principles.</description>
    <arm_group_label>CBT Phone Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Reading the Subject a Pamphlet on Obtaining Alcohol Use Disorder Treatment</intervention_name>
    <description>The pamphlet was created by the National Institute on Alcohol Abuse and Alcoholism to describe evidence based treatments available for alcohol use disorder and how to obtain such treatment.</description>
    <arm_group_label>Being Read A Pamphlet on Alcohol Treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age 18-plus;&#xD;
&#xD;
          -  score ≥ 16 on AUDIT;&#xD;
&#xD;
          -  within the past 30 days, exceeding the limits for low-risk drinking adopted by NIAAA:&#xD;
             &gt;3 standard drinks on any occasion or &gt;7 drinks per week (women); &gt;4 drinks on any&#xD;
             occasion or &gt;14 drinks per week (men).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  unable to communicate with the researcher in English;&#xD;
&#xD;
          -  unable to comprehend the nature of the study;&#xD;
&#xD;
          -  history of alcohol-related care;&#xD;
&#xD;
          -  alcohol withdrawal necessitating medical evaluation;&#xD;
&#xD;
          -  residency outside of The Greater Rochester Area.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Rochester</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14642</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>November 27, 2018</study_first_submitted>
  <study_first_submitted_qc>November 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 29, 2018</study_first_posted>
  <last_update_submitted>October 4, 2022</last_update_submitted>
  <last_update_submitted_qc>October 4, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 5, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Rochester</investigator_affiliation>
    <investigator_full_name>Kenneth Conner</investigator_full_name>
    <investigator_title>Professor, Emergency Medicine</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alcoholism</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>July 13, 2023</submitted>
    <returned>August 3, 2023</returned>
    <submitted>August 28, 2023</submitted>
  </pending_results>
  <!-- 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/NCT03758274
org study id: RSRB00072850
nct id: NCT03758274
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A small percentage of individuals with alcohol use disorder (AUD) obtain alcohol-related care
      despite research showing that treatment is effective. This randomized controlled trial tests
      the efficacy of a brief, phone based cognitive behavioral intervention to increase treatment
      engagement, improve alcohol related outcomes, and show that treatment engagement is a
      mechanism for the improved outcomes in individuals with AUD.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Average drinks per drinking day
time frame: 30 days
description: Average number of standard drinks on days of alcohol consumption
measure: Percent days abstinent
time frame: 30 days
description: Percentage of days abstinent from alcohol
measure: Number Initiating Alcohol Use Disorder Treatment
time frame: 30 days
description: Attendance at Alcohol Use Disorder Treatment
arm group label: CBT Phone Intervention
arm group type: Experimental
arm group label: Being Read A Pamphlet on Alcohol Treatment
arm group type: Active Comparator
intervention type: Behavioral
intervention name: CBT by Phone to Promote Treatment
description: Structured phone intervention to identify concerns about getting alcohol use disorder treatment and to work through those concerns using cognitive behavioral principles.
arm group label: CBT Phone Intervention
intervention type: Other
intervention name: Reading the Subject a Pamphlet on Obtaining Alcohol Use Disorder Treatment
description: The pamphlet was created by the National Institute on Alcohol Abuse and Alcoholism to describe evidence based treatments available for alcohol use disorder and how to obtain such treatment.
arm group label: Being Read A Pamphlet on Alcohol Treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Rochester
investigator full name: Kenneth Conner
investigator title: Professor, Emergency Medicine
mesh term: Alcoholism
sharing ipd: No
submitted: July 13, 2023
returned: August 3, 2023
submitted: August 28, 2023