<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/NCT02986776</url>
  </required_header>
  <id_info>
    <org_study_id>AA013625</org_study_id>
    <nct_id>NCT02986776</nct_id>
  </id_info>
  <brief_title>Treatment Settings for Those With an Alcohol Problem</brief_title>
  <official_title>Treatment Settings for Alcoholics: A Field Extension</official_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>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A prior study in a tightly controlled clinical research environment found individuals with an&#xD;
      alcohol use disorder (AUD) benefited more from inpatient (IP) than outpatient (OP) care, if&#xD;
      they presented with high alcohol involvement and/or low cognitive functioning. This study&#xD;
      sought to: (a) validate and extend these findings within the uncontrolled environment of a&#xD;
      community-based treatment center, and (b) test whether inpatients had fewer days of&#xD;
      involuntary abstinence (e.g., incarcerations) relative to outpatients. Based on their need&#xD;
      for inpatient treatment, using prior cut-points for alcohol involvement and cognitive&#xD;
      functioning, participants were randomly assigned within inpatient need group (No Need for IP;&#xD;
      Needs IP) to either 21-days of inpatient substance misuse treatment or 21-days of outpatient&#xD;
      treatment, all followed by 6 months of continuing outpatient care. Follow-up were conducted&#xD;
      an 90-day intervals across 18 months.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2002</start_date>
  <completion_date type="Actual">April 2008</completion_date>
  <primary_completion_date type="Actual">April 2008</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>Monthly Percentage of Voluntary Abstinent Days (from Timeline Followback Interview)</measure>
    <time_frame>Change up to 18 months</time_frame>
    <description>Percentage of Days Abstinent of those in which drinking was not restricted</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Monthly Point Prevalence of Abstinent Days (from Timeline Followback Interview)</measure>
    <time_frame>Change up to 18 months</time_frame>
    <description>Monthly percentage of participants abstinent throughout a month</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Monthly Drinks per Drinking Day (from Timeline Followback Interview)</measure>
    <time_frame>Change up to 18 months</time_frame>
    <description>For those drinking in a month, average drinks per drinking day</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Monthly percentage of Involuntary abstinent days (from Timeline Followback Interview)</measure>
    <time_frame>Up to 18 months</time_frame>
    <description>Monthly percentage of days in which the participant was incarcerated, hospitalized, or in residential treatment</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">176</enrollment>
  <condition>Alcohol Abuse</condition>
  <condition>Alcohol-dependence</condition>
  <arm_group>
    <arm_group_label>Inpatient Care + Needs Inpatient</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Individuals with high alcohol involvement or low cognitive functioning receiving inpatient treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Inpatient Care + No Need for Inpatient</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Individuals with low alcohol involvement or mid-high cognitive functioning receiving inpatient treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Outpatient Care + Needs Inpatient</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Individuals with high alcohol involvement or low cognitive functioning receiving outpatient treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Outpatient Care + No Need for Inpatient</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Individuals with low alcohol involvement and or mid-high cognitive functioning receiving outpatient treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Inpatient Care</intervention_name>
    <description>21 days of inpatient substance misuse treatment</description>
    <arm_group_label>Inpatient Care + Needs Inpatient</arm_group_label>
    <arm_group_label>Inpatient Care + No Need for Inpatient</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Outpatient Care</intervention_name>
    <description>21 days of outpatient substance misuse treatment</description>
    <arm_group_label>Outpatient Care + Needs Inpatient</arm_group_label>
    <arm_group_label>Outpatient Care + No Need for Inpatient</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Eligible for treatment through the Chemical Dependency treatment programs of a large,&#xD;
             community-based healthcare network&#xD;
&#xD;
          -  Drank alcoholic beverages within the last 90 days&#xD;
&#xD;
          -  Have a current address (not homeless)&#xD;
&#xD;
          -  Free of legal stipulations that would affect treatment decisions&#xD;
&#xD;
          -  Have a past 3 months Alcohol Use Disorder&#xD;
&#xD;
          -  Primary alcohol, or alcohol and drug problem&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Homeless&#xD;
&#xD;
          -  Drug problem only&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>December 6, 2016</study_first_submitted>
  <study_first_submitted_qc>December 6, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 8, 2016</study_first_posted>
  <last_update_submitted>October 8, 2020</last_update_submitted>
  <last_update_submitted_qc>October 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 12, 2020</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>Robert Rychtarik</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alcoholism</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/NCT02986776
org study id: AA013625
nct id: NCT02986776
lead sponsor: 
has dmc: No
A prior study in a tightly controlled clinical research environment found individuals with an
      alcohol use disorder (AUD) benefited more from inpatient (IP) than outpatient (OP) care, if
      they presented with high alcohol involvement and/or low cognitive functioning. This study
      sought to: (a) validate and extend these findings within the uncontrolled environment of a
      community-based treatment center, and (b) test whether inpatients had fewer days of
      involuntary abstinence (e.g., incarcerations) relative to outpatients. Based on their need
      for inpatient treatment, using prior cut-points for alcohol involvement and cognitive
      functioning, participants were randomly assigned within inpatient need group (No Need for IP;
      Needs IP) to either 21-days of inpatient substance misuse treatment or 21-days of outpatient
      treatment, all followed by 6 months of continuing outpatient care. Follow-up were conducted
      an 90-day intervals across 18 months.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Monthly Percentage of Voluntary Abstinent Days (from Timeline Followback Interview)
time frame: Change up to 18 months
description: Percentage of Days Abstinent of those in which drinking was not restricted
measure: Monthly Point Prevalence of Abstinent Days (from Timeline Followback Interview)
time frame: Change up to 18 months
description: Monthly percentage of participants abstinent throughout a month
measure: Monthly Drinks per Drinking Day (from Timeline Followback Interview)
time frame: Change up to 18 months
description: For those drinking in a month, average drinks per drinking day
measure: Monthly percentage of Involuntary abstinent days (from Timeline Followback Interview)
time frame: Up to 18 months
description: Monthly percentage of days in which the participant was incarcerated, hospitalized, or in residential treatment
arm group label: Inpatient Care + Needs Inpatient
arm group type: Active Comparator
description: Individuals with high alcohol involvement or low cognitive functioning receiving inpatient treatment
arm group label: Inpatient Care + No Need for Inpatient
arm group type: Active Comparator
description: Individuals with low alcohol involvement or mid-high cognitive functioning receiving inpatient treatment
arm group label: Outpatient Care + Needs Inpatient
arm group type: Active Comparator
description: Individuals with high alcohol involvement or low cognitive functioning receiving outpatient treatment
arm group label: Outpatient Care + No Need for Inpatient
arm group type: Active Comparator
description: Individuals with low alcohol involvement and or mid-high cognitive functioning receiving outpatient treatment
intervention type: Behavioral
intervention name: Inpatient Care
description: 21 days of inpatient substance misuse treatment
arm group label: Inpatient Care + Needs Inpatient
arm group label: Inpatient Care + No Need for Inpatient
intervention type: Behavioral
intervention name: Outpatient Care
description: 21 days of outpatient substance misuse treatment
arm group label: Outpatient Care + Needs Inpatient
arm group label: Outpatient Care + No Need for Inpatient
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: State University of New York at Buffalo
investigator full name: Robert Rychtarik
investigator title: Principal Investigator
mesh term: Alcoholism