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Wearable Biosensor Accuracy for Alcohol Intoxication
N/A
Recruiting
Led By Catharine Fairbairn, PhD
Research Sponsored by University of Illinois at Urbana-Champaign
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up across the 14 day period of the study
Awards & highlights
No Placebo-Only Group
Summary
This trial will track participants' alcohol use over 14 days with sensors and breathalyzers, and involve 3 lab sessions to assess alcohol dose/rate of consumption.
Who is the study for?
This trial is for individuals who are at least 21 years old and drink alcohol at least twice a week. It's not suitable for those with medical or psychological conditions that make drinking unsafe, people currently treating an alcohol use disorder, pregnant women, or anyone taking medications that interact badly with alcohol.
What is being tested?
The study tests the accuracy of new wearable biosensors in measuring blood alcohol content (BAC). Participants will wear these sensors over two weeks while providing breathalyzer data during real-world drinking and controlled lab sessions where their drinking amounts vary.
What are the potential side effects?
Since the intervention involves consuming alcohol, potential side effects include typical reactions to intoxication such as impaired coordination, dizziness, nausea, vomiting, hangovers, and in severe cases acute alcohol poisoning.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ across the 14 day period of the study
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~across the 14 day period of the study
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Transdermal estimates of alcohol consumption
Transdermal estimates of blood alcohol concentration
Transdermal estimates of drinking risk level
Side effects data
From 2017 Phase 2 trial • 17 Patients • NCT0177902459%
Increased Appetite
41%
Somnolence
35%
Euphoric mood
29%
Fatigue
12%
Hyperhidrosis
12%
Memory impairment
12%
Dizziness
12%
Nausea
6%
Feeling hot
6%
Flushing
6%
Headache
6%
Decreased appetite
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ghrelin
Placebo
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Slow ConditionExperimental Treatment1 Intervention
Participants randomized to consume study beverages at a comparatively slow rate.
Group II: Fast ConditionExperimental Treatment1 Intervention
Participants randomized to consume study beverages at a comparatively rapid rate.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Alcohol
2008
Completed Phase 3
~1990
Find a Location
Who is running the clinical trial?
National Institutes of Health (NIH)NIH
2,810 Previous Clinical Trials
8,159,392 Total Patients Enrolled
University of Illinois at Urbana-ChampaignLead Sponsor
197 Previous Clinical Trials
38,035 Total Patients Enrolled
Catharine Fairbairn, PhDPrincipal InvestigatorUniversity of Illinois Urbana-Champaign
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am on medication that should not be mixed with alcohol.I am currently pregnant or trying to get pregnant.I am 21 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Fast Condition
- Group 2: Slow Condition
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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