A Machine Learning Approach for Inferring Alcohol Intoxication Levels From Gait Data (Alcogait)

This study aims to develop a phone app to assess gait differences at different levels of alcohol intoxication.

Study Overview

• Status: Completed
• Conditions: Alcohol Drinking
• Intervention / Treatment: Other: All Participants

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.

• Study Type: Interventional
• Enrollment (Actual): 141
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02906
      • Butler Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: All Participants; 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.	Other: All Participants; all participants will participate in the same protocol involving drinking alcohol to a .08 g% blood alcohol level

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Phone App	a phone app to compare gait changes with blood alcohol levels will be developed based on participant's gait during alcohol use	data from each participant will be collected during a one-visit study session

Collaborators and Investigators

• Sponsor: Butler Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2017
• Primary Completion (Actual): July 31, 2019
• Study Completion (Actual): July 31, 2019

Study Registration Dates

• First Submitted: July 26, 2017
• First Submitted That Met QC Criteria: August 8, 2017
• First Posted (Actual): August 11, 2017

Study Record Updates

• Last Update Posted (Actual): April 7, 2020
• Last Update Submitted That Met QC Criteria: April 5, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Drinking Behavior; Alcohol-Related Disorders; Substance-Related Disorders; Alcohol Drinking; Alcoholic Intoxication
• Other Study ID Numbers: AA025193

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No