<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/NCT01689103</url>
  </required_header>
  <id_info>
    <org_study_id>1R01AA020253</org_study_id>
    <nct_id>NCT01689103</nct_id>
  </id_info>
  <brief_title>Therapeutic Alliances in Alcoholism Treatment</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>State University of New York at Buffalo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>State University of New York at Buffalo</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This project is studying the role of the therapeutic alliance between the therapist and&#xD;
      patient in the outpatient treatment of persons with alcohol use disorders.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This project is studying the role of the therapeutic alliance between the therapist and&#xD;
      patient in the outpatient treatment of persons with alcohol use disorders. Alliances are&#xD;
      assessed over the course of treatment and will be reviewed in the context of posttreatment&#xD;
      functioning.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">April 26, 2022</completion_date>
  <primary_completion_date type="Actual">April 1, 2022</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>Percent days abstinent</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Drinks per Drinking Day</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">166</enrollment>
  <condition>Alcohol Use Disorders</condition>
  <arm_group>
    <arm_group_label>Alliance Feedback to Therapist</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Alliance feedback provided to therapist</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No alliance feedback to therapist</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>No alliance feedback provided to therapist</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitive-behavioral treatment</intervention_name>
    <description>Cognitive-behavioral treatment of alcohol use disorders</description>
    <arm_group_label>Alliance Feedback to Therapist</arm_group_label>
    <arm_group_label>No alliance feedback to therapist</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitive-behavioral treatment</intervention_name>
    <description>Cognitive-behavioral treatment for alcohol use disorders</description>
    <arm_group_label>Alliance Feedback to Therapist</arm_group_label>
    <arm_group_label>No alliance feedback to therapist</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Current Alcohol Dependence diagnosis&#xD;
&#xD;
          -  Live within commuting distance of treatment program&#xD;
&#xD;
          -  Minimum 6th grade reading level&#xD;
&#xD;
          -  Provide consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of current organic mental disorder, schizophrenia, or another psychotic&#xD;
             disorder&#xD;
&#xD;
          -  Treatment for an alcohol use disorder in past 12 months&#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>Gerard J Connors, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University at Buffalo</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Stephen A Maisto, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Syracuse University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ronda L Dearing, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University at Buffalo</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Research Institute on Addictions</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>14203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>September 17, 2012</study_first_submitted>
  <study_first_submitted_qc>September 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 20, 2012</study_first_posted>
  <last_update_submitted>April 26, 2022</last_update_submitted>
  <last_update_submitted_qc>April 26, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 27, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>State University of New York at Buffalo</investigator_affiliation>
    <investigator_full_name>Gerard J. Connors</investigator_full_name>
    <investigator_title>Senior Research Scientist</investigator_title>
  </responsible_party>
  <keyword>Alcohol use disorders</keyword>
  <keyword>Treatment</keyword>
  <keyword>Outpatient</keyword>
  <keyword>Therapeutic alliance</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alcoholism</mesh_term>
    <mesh_term>Alcohol Drinking</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/NCT01689103
org study id: 1R01AA020253
nct id: NCT01689103
lead sponsor: 
has dmc: Yes
This project is studying the role of the therapeutic alliance between the therapist and
      patient in the outpatient treatment of persons with alcohol use disorders.
This project is studying the role of the therapeutic alliance between the therapist and
      patient in the outpatient treatment of persons with alcohol use disorders. Alliances are
      assessed over the course of treatment and will be reviewed in the context of posttreatment
      functioning.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Percent days abstinent
time frame: 12 months
measure: Drinks per Drinking Day
time frame: 12 months
arm group label: Alliance Feedback to Therapist
arm group type: Experimental
description: Alliance feedback provided to therapist
arm group label: No alliance feedback to therapist
arm group type: Placebo Comparator
description: No alliance feedback provided to therapist
intervention type: Behavioral
intervention name: Cognitive-behavioral treatment
description: Cognitive-behavioral treatment of alcohol use disorders
arm group label: Alliance Feedback to Therapist
arm group label: No alliance feedback to therapist
intervention type: Behavioral
intervention name: Cognitive-behavioral treatment
description: Cognitive-behavioral treatment for alcohol use disorders
arm group label: Alliance Feedback to Therapist
arm group label: No alliance feedback to therapist
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Gerard J Connors, Ph.D.
role: Principal Investigator
affiliation: University at Buffalo
last name: Stephen A Maisto, PhD
role: Principal Investigator
affiliation: Syracuse University
last name: Ronda L Dearing, PhD
role: Principal Investigator
affiliation: University at Buffalo
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: State University of New York at Buffalo
investigator full name: Gerard J. Connors
investigator title: Senior Research Scientist
mesh term: Alcoholism
mesh term: Alcohol Drinking