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Calibration Study of a Blood Alcohol Level Smart Watch

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ClinicalTrials.gov Identifier: NCT03574181
Recruitment Status : Terminated (Extensive changes to the watch design would be needed to produce a robust device.)
First Posted : June 29, 2018
Last Update Posted : April 28, 2020
Sponsor:
Collaborators:
KWJ Engineering
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Eric Devine, Boston Medical Center

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.

Condition or disease Intervention/treatment
Alcohol Drinking Other: Smart watch to measure Blood Alcohol Level

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.

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Study Type : Observational
Actual Enrollment : 11 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Calibration Study of a Wearable Noninvasive Blood Alcohol Monitor
Actual Study Start Date : July 8, 2019
Actual Primary Completion Date : February 17, 2020
Actual Study Completion Date : February 17, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol


Intervention Details:
  • Other: Smart watch to measure Blood Alcohol Level
    Subjects will wear a wrist watch that measures blood alcohol level during a 1 hour period of consuming alcohol followed by a 5 hour observation period.


Primary Outcome Measures :
  1. Breathalyzer blood alcohol level [ Time Frame: 6 hours ]
    Concentration of blood alcohol measured by a breathalyzer

  2. Smart watch blood alcohol level [ Time Frame: 6 hours ]
    Concentration of blood alcohol measured by a smart watch



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Moderate (non-problem) drinking healthy volunteers
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03574181


Locations
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United States, Massachusetts
Boston University Psychiatry Research Center, Clinical Studies Unit
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston Medical Center
KWJ Engineering
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
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Principal Investigator: Eric Devine, PhD Boston Medical Center
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Responsible Party: Eric Devine, Assistant Professor, Dept of Psychiatry, Boston Medical Center
ClinicalTrials.gov Identifier: NCT03574181    
Other Study ID Numbers: H-36914
R44AA024651-02 ( U.S. NIH Grant/Contract )
First Posted: June 29, 2018    Key Record Dates
Last Update Posted: April 28, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eric Devine, Boston Medical Center:
Wrist watch blood alcohol level
Blood alcohol
Objective alcohol measure
Additional relevant MeSH terms:
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Alcohol Drinking
Drinking Behavior