Clinical trial NCT03574181: Calibration Study of a Blood Alcohol Level Smart Watch
Official title: Calibration Study of a Wearable Noninvasive Blood Alcohol Monitor
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Alcohol Drinking
Keywords: Wrist watch blood alcohol level
Blood alcohol
Objective alcohol measure
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: KWJ Engineering
name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2018-06-29
Enrollment: 9
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Moderate (non-problem) drinking healthy volunteers

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Correlation Between Breathalyzer and Wristwatch Sensor BAL Measurements
timeFrame: 6 hours during alcohol self administration trial
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston University Psychiatry Research Center, Clinical Studies Unit
state: Massachusetts
Study officials:
affiliation: Boston Medical Center
name: Eric Devine, PhD
role: PRINCIPAL_INVESTIGATOR
References: