Calibration Study of a Blood Alcohol Level Smart Watch

Calibration Study of a Wearable Noninvasive Blood Alcohol Monitor

This trial is designed to test the accuracy of a wristwatch blood alcohol level monitor relative to alcohol breath testing. An established human laboratory self-administration procedure will be followed. Each subject will complete 2 clinic visits over a period of up to 21 days of participation. Study participation is comprised of a baseline assessment to determine eligibility and an alcohol self-administration trial to test the accuracy of the wrist watch blood alcohol level. Subjects will be recruited in two phases of 9 subjects each. The first phase will be conducted to validate a prototype of the wrist watch. The second phase will be conducted to validate a pre-production consumer model of the blood alcohol wrist watch.

Study Overview

• Status: Terminated
• Conditions: Alcohol Drinking
• Intervention / Treatment: Other: Smartwatch to measure Blood Alcohol Level (BAL)

Detailed Description

In this proposed study, the objective is to further demonstrate the reliability of this printed electrochemical gas sensor in the form of a wearable device. This demonstration of reliability among human subjects is an essential part of product development. The monitor will be in a wristband or watch form, similar to a smart watch. This device will be modern, attractive and comfortable. It will also have smart watch features including measuring key physiological parameters (e.g., pulse) and eventually will have connectivity to apps on smart phones and other devices. The aim of the work is to provide a new, noninvasive transdermal alcohol monitor into the market. The transdermal alcohol monitoring market has few wearable products available and innovation has been lacking in this field. This new product will take advantage of current trends in wearable technology. As the public becomes more comfortable with wearable sensors, the blood alcohol monitor will become popular with people interested in health and fitness who want to track their alcohol intake. The product will provide a new, highly reliable and sensitive method for tracking blood alcohol level. This may be particularly beneficial to individuals who seek to reduce the risk of alcohol use by limiting peak blood alcohol level. If successful, this technology could be adopted in many areas including clinical and medical treatment, employee wellness programs, alcohol clinical trials, and as part of brief interventions that target at-risk drinkers.

The specific objective of this study is to determine whether the printed electrochemical gas sensor designed to measure blood alcohol level will be sensitive and reliable when compared to a standard measure of blood alcohol level taken by a breathalyzer. If this sensor proves sensitive to changes in blood alcohol level and can reliably measure blood alcohol level relative to a "gold standard" method, there are significant opportunities to use this technology in consumer health applications and clinical research.

• Study Type: Observational
• Enrollment (Actual): 9

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston University Psychiatry Research Center, Clinical Studies Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 53 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Moderate (non-problem) drinking healthy volunteers

Description

Inclusion Criteria:

1. 21-55 years of age.
2. Can provide proof of age with state or federal picture Identification.
3. Consumes an average of ≥7 standard drinks per week (women) or ≥14 drinks per week (men) over the 28 days prior to consent.
4. Has consumed at least 4 standard drinks on a single day on at least two days in the past 28 days prior to consent.
5. Has a blood alcohol level = 0.000 at time of consent.
6. Is able to understand and provide written informed consent.
7. Body weight ≥ 120 lbs and ≤ 250 pounds
8. Subjects can speak and understand English

Exclusion Criteria:

1. Currently seeking treatment for alcohol problems or purposefully abstaining from alcohol in an attempt to cut back or quit drinking.
2. Clinical Institute Withdrawal Assessment at ≥10.
3. Meets DSM-5 diagnosis of current major depression, bipolar disorder, schizophrenia, bulimia/anorexia, dementia, or a substance use disorder other than alcohol, nicotine, marijuana, or caffeine
4. If female, pregnant or nursing.
5. If female, does not agree to use an accepted form of birth control
6. Has medical or mental condition for which further alcohol exposure at the planned dose range would be contraindicated.
7. Taking medication for which drinking would be contraindicated.
8. Clinically significant abnormal ECG.
9. AST or ALT ≥ 3x the upper limit of normal.
10. Current risk of suicidality.
11. Has taken medications that are used to treat AUD in the past 90 days.
12. Has received alcohol counseling or other non-pharmacologic intervention to treat alcohol use disorder in the past 90 days.
13. Has urine toxicology results positive for cocaine, opioids, amphetamines, buprenorphine, methadone, or methamphetamines.
14. Smokes greater than 5 cigarettes per day.
15. Unable to comfortably abstain from nicotine for a period of 8 hours.
16. Wearing cologne, perfume, aftershave or any other scented oil or alcohol-based beauty product on the day of the Alcohol Lab Visit.
17. Has dietary restrictions that would preclude participating.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation Between Breathalyzer and Wristwatch Sensor BAL Measurements	Wristwatch sensor BAL is continuously measured for entirety of 6-hour alcohol self administration trial. BAL from breathalyzer (BrAC) is measured at 15-minute intervals throughout 6-hour alcohol self administration trial. The correlation between wristwatch transdermal BAL (TAC) and breathalyzer BAL (BrAC) for all subjects will be calculated.	6 hours during alcohol self administration trial

Collaborators and Investigators

• Sponsor: Boston Medical Center
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA); KWJ Engineering
• Investigators: Principal Investigator: Eric Devine, PhD, Boston Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): July 8, 2019
• Primary Completion (Actual): February 17, 2020
• Study Completion (Actual): February 17, 2020

Study Registration Dates

• First Submitted: June 20, 2018
• First Submitted That Met QC Criteria: June 20, 2018
• First Posted (Actual): June 29, 2018

Study Record Updates

• Last Update Posted (Actual): February 18, 2021
• Last Update Submitted That Met QC Criteria: February 2, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Wrist watch blood alcohol level; Blood alcohol; Objective alcohol measure
• Additional Relevant MeSH Terms: Drinking Behavior; Alcohol Drinking
• Other Study ID Numbers: H-36914; R44AA024651-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

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