NCT03246490

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
141

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 26, 2017

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 11, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

December 12, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2019

Completed
Last Updated

April 7, 2020

Status Verified

April 1, 2020

Enrollment Period

1.6 years

First QC Date

July 26, 2017

Last Update Submit

April 5, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

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.

Other: All Participants

Interventions

all participants will participate in the same protocol involving drinking alcohol to a .08 g% blood alcohol level

All Participants

Eligibility Criteria

Age21 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Butler Hospital

Providence, Rhode Island, 02906, United States

Location

MeSH Terms

Conditions

Alcohol Drinking

Condition Hierarchy (Ancestors)

Drinking BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

July 26, 2017

First Posted

August 11, 2017

Study Start

December 12, 2017

Primary Completion

July 31, 2019

Study Completion

July 31, 2019

Last Updated

April 7, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations