Back to resultsA Machine Learning Approach for Inferring Alcohol Intoxication Levels From Gait Data (Alcogait)
Primary Purpose
Alcohol Drinking
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
All Participants
Sponsored by
About this trial
This is an interventional other trial for Alcohol Drinking
Eligibility Criteria
Inclusion Criteria:
- ages 21-65
- drinking at least 5 drinks per occasion for men (4 for women) during a single drinking episode at least once in the last month to ensure, for safety reasons, that people are accustomed to consuming alcohol in amounts comparable to what we will administer
- willingness to drink beer (since only beer will be provided in the session to standardize drinks more easily).
Exclusion Criteria:
- past 6 months or current treatment for alcohol or drug abuse by self-report (for ethical reasons)
- Score > 5 on (the short version of the Michigan Alcohol Screening Test [SMAST]48) given during the screening interview
- positive family history of alcohol use disorder
- weight ≥ 230 lbs (to prevent excessive volume of beverage)
- current use of medications that are contraindicated for alcohol
- a health condition that contraindicates alcohol (e.g. peptic ulcer disease)
- a health condition that affects ability to walk
- if female, pregnant or nursing
- use of recreational drugs (e.g., marijuana, opioids, stimulants, benzodiazepines) within the last week (self-report plus urine screening cup)
- persons who report alcohol-induced flushing, an untoward reaction that is often accompanied by headache, nausea and other symptoms
Sites / Locations
- Butler Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
All Participants
Arm 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.
Outcomes
Primary Outcome Measures
Phone App
a phone app to compare gait changes with blood alcohol levels will be developed based on participant's gait during alcohol use
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03246490
Brief Title
A Machine Learning Approach for Inferring Alcohol Intoxication Levels From Gait Data
Acronym
Alcogait
Official Title
A Machine Learning Approach for Inferring Alcohol Intoxication Levels From Gait Data
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
December 12, 2017 (Actual)
Primary Completion Date
July 31, 2019 (Actual)
Study Completion Date
July 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Butler Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study aims to develop a phone app to assess gait differences at different levels of alcohol intoxication.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Drinking
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
141 (Actual)
8. Arms, Groups, and Interventions
Arm Title
All Participants
Arm Type
Other
Arm 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(s)
All Participants
Intervention Description
all participants will participate in the same protocol involving drinking alcohol to a .08 g% blood alcohol level
Primary Outcome Measure Information:
Title
Phone App
Description
a phone app to compare gait changes with blood alcohol levels will be developed based on participant's gait during alcohol use
Time Frame
data from each participant will be collected during a one-visit study session
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
ages 21-65
drinking at least 5 drinks per occasion for men (4 for women) during a single drinking episode at least once in the last month to ensure, for safety reasons, that people are accustomed to consuming alcohol in amounts comparable to what we will administer
willingness to drink beer (since only beer will be provided in the session to standardize drinks more easily).
Exclusion Criteria:
past 6 months or current treatment for alcohol or drug abuse by self-report (for ethical reasons)
Score > 5 on (the short version of the Michigan Alcohol Screening Test [SMAST]48) given during the screening interview
positive family history of alcohol use disorder
weight ≥ 230 lbs (to prevent excessive volume of beverage)
current use of medications that are contraindicated for alcohol
a health condition that contraindicates alcohol (e.g. peptic ulcer disease)
a health condition that affects ability to walk
if female, pregnant or nursing
use of recreational drugs (e.g., marijuana, opioids, stimulants, benzodiazepines) within the last week (self-report plus urine screening cup)
persons who report alcohol-induced flushing, an untoward reaction that is often accompanied by headache, nausea and other symptoms
Facility Information:
Facility Name
Butler Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Machine Learning Approach for Inferring Alcohol Intoxication Levels From Gait Data
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