Calibration Study of a Blood Alcohol Level Smart Watch

Stopped early

Conditions studied: Alcohol Drinking

In brief

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.

Key facts

Study ID

NCT03574181

Run by

Boston Medical Center

People needed

9

Starts

2019-07-08

Expected to finish

2020-02-17

Last updated by the study team

2021-02-18

Who can join

Age: 21 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.
• Clinically significant abnormal ECG.
• AST or ALT ≥ 3x the upper limit of normal.
• Current risk of suicidality.
• Has taken medications that are used to treat AUD in the past 90 days.
• Has received alcohol counseling or other non-pharmacologic intervention to treat alcohol use disorder in the past 90 days.
• Has urine toxicology results positive for cocaine, opioids, amphetamines, buprenorphine, methadone, or methamphetamines.
• Smokes greater than 5 cigarettes per day.
• Unable to comfortably abstain from nicotine for a period of 8 hours.
• Wearing cologne, perfume, aftershave or any other scented oil or alcohol-based beauty product on the day of the Alcohol Lab Visit.
• Has dietary restrictions that would preclude participating.

Where it is running

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

Full record on ClinicalTrials.gov

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