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 range
21 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Correlation Between Breathalyzer and Wristwatch Sensor BAL Measurements
Timeframe: 6 hours during alcohol self administration trial
. 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.
. 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.