<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/NCT03246490</url>
  </required_header>
  <id_info>
    <org_study_id>AA025193</org_study_id>
    <nct_id>NCT03246490</nct_id>
  </id_info>
  <brief_title>A Machine Learning Approach for Inferring Alcohol Intoxication Levels From Gait Data</brief_title>
  <acronym>Alcogait</acronym>
  <official_title>A Machine Learning Approach for Inferring Alcohol Intoxication Levels From Gait Data</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Butler Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Butler Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This study aims to develop a phone app to assess gait differences at different levels of&#xD;
      alcohol intoxication.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      250 adult volunteers who will each participate in a single laboratory-based visit. At the&#xD;
      orientation, each participant will provide informed consent, be weighed, and undergo a&#xD;
      medical history to confirm eligibility. A urine drug quick-screen will be given. Female&#xD;
      participants will take a urine pregnancy test. Baseline questionnaires will be administered.&#xD;
      After giving participants the phone on which the AlcoGait 2.0 app is installed, baseline&#xD;
      assessment of gait will be performed with the participant walking a distance of 50 yards ten&#xD;
      times.&#xD;
&#xD;
      Drinking will then commence. The total amount will be consumed over 30 minutes. Participants&#xD;
      will have their BrAC assessed multiple times during and after drinking has commenced and&#xD;
      finished. At BrAC levels of .02, .04, .06 and .08 g%, will perform the gait task. After the&#xD;
      last gait task, participant data will be transmitted to a secure server. Participants will&#xD;
      receive a meal, and will be escorted to a sitting area with a DVR and videos, and allowed to&#xD;
      use their own electronic devices. Their BrAC will be periodically tested until it reaches .02&#xD;
      g% or below, then a taxi will be called to take them home.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 12, 2017</start_date>
  <completion_date type="Actual">July 31, 2019</completion_date>
  <primary_completion_date type="Actual">July 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>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Phone App</measure>
    <time_frame>data from each participant will be collected during a one-visit study session</time_frame>
    <description>a phone app to compare gait changes with blood alcohol levels will be developed based on participant's gait during alcohol use</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">141</enrollment>
  <condition>Alcohol Drinking</condition>
  <arm_group>
    <arm_group_label>All Participants</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>All participants complete the same study procedures, which involve drinking alcohol to a .08 blood alcohol level and walking short distances while their blood alcohol level is increasing to .08 and decreasing down to .00.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>All Participants</intervention_name>
    <description>all participants will participate in the same protocol involving drinking alcohol to a .08 g% blood alcohol level</description>
    <arm_group_label>All Participants</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ages 21-65&#xD;
&#xD;
          -  drinking at least 5 drinks per occasion for men (4 for women) during a single drinking&#xD;
             episode at least once in the last month to ensure, for safety reasons, that people are&#xD;
             accustomed to consuming alcohol in amounts comparable to what we will administer&#xD;
&#xD;
          -  willingness to drink beer (since only beer will be provided in the session to&#xD;
             standardize drinks more easily).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  past 6 months or current treatment for alcohol or drug abuse by self-report (for&#xD;
             ethical reasons)&#xD;
&#xD;
          -  Score &gt; 5 on (the short version of the Michigan Alcohol Screening Test [SMAST]48)&#xD;
             given during the screening interview&#xD;
&#xD;
          -  positive family history of alcohol use disorder&#xD;
&#xD;
          -  weight ≥ 230 lbs (to prevent excessive volume of beverage)&#xD;
&#xD;
          -  current use of medications that are contraindicated for alcohol&#xD;
&#xD;
          -  a health condition that contraindicates alcohol (e.g. peptic ulcer disease)&#xD;
&#xD;
          -  a health condition that affects ability to walk&#xD;
&#xD;
          -  if female, pregnant or nursing&#xD;
&#xD;
          -  use of recreational drugs (e.g., marijuana, opioids, stimulants, benzodiazepines)&#xD;
             within the last week (self-report plus urine screening cup)&#xD;
&#xD;
          -  persons who report alcohol-induced flushing, an untoward reaction that is often&#xD;
             accompanied by headache, nausea and other symptoms&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Butler Hospital</name>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02906</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>July 26, 2017</study_first_submitted>
  <study_first_submitted_qc>August 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2017</study_first_posted>
  <last_update_submitted>April 5, 2020</last_update_submitted>
  <last_update_submitted_qc>April 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Butler Hospital</investigator_affiliation>
    <investigator_full_name>Michael Stein, MD</investigator_full_name>
    <investigator_title>PI</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alcoholic Intoxication</mesh_term>
    <mesh_term>Alcohol Drinking</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03246490
org study id: AA025193
nct id: NCT03246490
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study aims to develop a phone app to assess gait differences at different levels of
      alcohol intoxication.
250 adult volunteers who will each participate in a single laboratory-based visit. At the
      orientation, each participant will provide informed consent, be weighed, and undergo a
      medical history to confirm eligibility. A urine drug quick-screen will be given. Female
      participants will take a urine pregnancy test. Baseline questionnaires will be administered.
      After giving participants the phone on which the AlcoGait 2.0 app is installed, baseline
      assessment of gait will be performed with the participant walking a distance of 50 yards ten
      times.

      Drinking will then commence. The total amount will be consumed over 30 minutes. Participants
      will have their BrAC assessed multiple times during and after drinking has commenced and
      finished. At BrAC levels of .02, .04, .06 and .08 g%, will perform the gait task. After the
      last gait task, participant data will be transmitted to a secure server. Participants will
      receive a meal, and will be escorted to a sitting area with a DVR and videos, and allowed to
      use their own electronic devices. Their BrAC will be periodically tested until it reaches .02
      g% or below, then a taxi will be called to take them home.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Phone App
time frame: data from each participant will be collected during a one-visit study session
description: a phone app to compare gait changes with blood alcohol levels will be developed based on participant's gait during alcohol use
arm group label: All Participants
arm group type: Other
description: All participants complete the same study procedures, which involve drinking alcohol to a .08 blood alcohol level and walking short distances while their blood alcohol level is increasing to .08 and decreasing down to .00.
intervention type: Other
intervention name: All Participants
description: all participants will participate in the same protocol involving drinking alcohol to a .08 g% blood alcohol level
arm group label: All Participants
criteria: 
gender: All
minimum age: 21 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Butler Hospital
investigator full name: Michael Stein, MD
investigator title: PI
mesh term: Alcoholic Intoxication
mesh term: Alcohol Drinking
sharing ipd: No