Alcohol DrinkingAlcogaitNCT03246490
A Machine Learning Approach for Inferring Alcohol Intoxication Levels From Gait Data
A study testing All Participants in people with Alcohol Drinking, run by Butler Hospital at 1 site in United States.
Trial summary
This study aims to develop a phone app to assess gait differences at different levels of alcohol intoxication. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Alcohol Drinking
- What is being tested?
- All Participants
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Dec 2017to 31 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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)
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to develop a phone app to assess gait differences at different levels of alcohol intoxication.
Read the 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.
- Conditions
- Alcohol Drinking
- Being tested
- All Participants
- Medical subject headings
- Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
All ParticipantsOther
all participants will participate in the same protocol involving drinking alcohol to a .08 g% blood alcohol level
| Study group | Role | What they receive |
|---|---|---|
| All Participants | Other | 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. Receives: Other: All Participants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phone App
a phone app to compare gait changes with blood alcohol levels will be developed based on participant's gait during alcohol use
Measured: data from each participant will be collected during a one-visit study session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2017
- Study start12 Dec 2017
- Primary completion31 Jul 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol DrinkingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Butler Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Stein, MD, Butler Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03246490
- Sponsor's protocol ID
- AA025193
- Acronym
- Alcogait
- Status last verified
- Apr 2020
- First submitted
- 26 Jul 2017
- Last updated
- 7 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Machine Learning Approach for Inferring Alcohol Intoxication Levels From Gait Data
- ClinicalTrials.gov ID
- NCT03246490
- Acronym / sponsor ID
- Alcogait / AA025193
- Conditions
- Alcohol Drinking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Butler HospitalUniversity, hospital or other
- Study start
- 12 Dec 2017 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 11 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Participants | Other | Other: All ParticipantsAll 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. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| All Participantsall participants will participate in the same protocol involving drinking alcohol to a .08 g% blood alcohol level | Other | All Participants |
Primary outcome
Phone App
Time frame: data from each participant will be collected during a one-visit study session
a phone app to compare gait changes with blood alcohol levels will be developed based on participant's gait during alcohol use
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing All Participants in people with Alcohol Drinking, run by Butler Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phone App (time frame: data from each participant will be collected during a one-visit study session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2020.