Calibration Study of a Blood Alcohol Level Smart Watch (NCT03574181) | Clinical Trial Compass
TerminatedNot Applicable
Calibration Study of a Blood Alcohol Level Smart Watch
Stopped: Extensive changes to the watch design would be needed to produce a robust device.
United States9 participantsStarted 2019-07-08
Plain-language 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.
Who can participate
Age range21 Years – 55 Years
SexALL
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Inclusion criteria
✓. 21-55 years of age.
✓. Can provide proof of age with state or federal picture Identification.
✓. Consumes an average of ≥7 standard drinks per week (women) or ≥14 drinks per week (men) over the 28 days prior to consent.
✓. Has consumed at least 4 standard drinks on a single day on at least two days in the past 28 days prior to consent.
✓. Has a blood alcohol level = 0.000 at time of consent.
✓. Is able to understand and provide written informed consent.
✓. Body weight ≥ 120 lbs and ≤ 250 pounds
✓. Subjects can speak and understand English
Exclusion criteria
✕. Currently seeking treatment for alcohol problems or purposefully abstaining from alcohol in an attempt to cut back or quit drinking.
✕. Clinical Institute Withdrawal Assessment at ≥10.
What they're measuring
1
Correlation Between Breathalyzer and Wristwatch Sensor BAL Measurements
Timeframe: 6 hours during alcohol self administration trial
✕. 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
✕. If female, pregnant or nursing.
✕. If female, does not agree to use an accepted form of birth control
✕. Has medical or mental condition for which further alcohol exposure at the planned dose range would be contraindicated.
✕. Taking medication for which drinking would be contraindicated.