BACtrack Skyn Human Clinical Study Survey

Testers Needed for Clinical Trial of Wearable Alcohol Concentration (BAC) Device

**IF YOU HAVE ALREADY PARTICIPATED IN, OR APPLIED TO, A BREATHALYZER STUDY YOU ARE NOT ELIGIBLE. PLEASE DO NOT REAPPLY**

We are seeking 8 adults (21+ only) for a clinical research study to come to our facility in San Francisco, CA, and drink participant-specific doses of alcoholic drinks (beer, wine, and liquor selections available) sufficient to reach ~0.080 % blood alcohol concentration (“BAC”), while wearing a small investigational wrist monitor device intended to evaluate the user’s estimated BAC ranges.

Purpose: The purpose of this clinical study is to investigate the statistical agreement and ease-of-use of an investigational wrist monitor device in measuring a wearer’s estimated BAC, as compared to a traditional FDA-cleared breathalyzer device. The wrist monitor device is intended to estimate BAC by monitoring alcohol that is excreted from the wearer’s skin.

The investigative device is not intended, nor indicated for use, to treat any disease, including, but not limited to, those related to alcohol use disorder (AUD).  This is not a medical study with any treatments; it is simply to check for device efficacy and ease of use. Compensation as noted below. There is no consequence nor potential negative outcome if you do not participate in this study. By participating in this study, you consent to sharing your personal data with us as it relates to the recruitment, screening, or actual study procedures. Before the study begins, you will be provided with an Informed Consent document which will outline what data may be collected and for what purposes. You will be able to ask questions before you sign the document.

Details:

• This study will take place over the course of one day at our San Francisco office facility and is strictly voluntary.
• Participants will be asked to come to our office facility to drink a specifically calculated amount of alcohol to reach ~0.080 % BAC.
• Participants will also wear a wrist monitor and use an app to observe some data.
• Participants will remain in the office and be tested with an FDA-cleared breathalyzer device as their alcohol level comes down.
• Participants must be willing to stay in our office until 530pm or their % BAC is 0.000%, whichever is LATER.
• Participants will need to wear the device for the full duration of the study.
• Participants are required to fill out a subject survey prior to the date of the study.
• The study location will provide alcohol (various types) and comfortable office space with Wi-Fi. 

Date:

• Every Wednesday until the end of May

Location:

• San Francisco Financial District near the Embarcadero

Time:

• 9 am to ~ 5:30 pm (or when sober)

Compensation:

• $200 Visa gift card upon successful completion of breath testing and wearing the devices all day.

Requirements:

• MUST BE BETWEEN 21 and 55 YEARS OF AGE.
• Must be fully vaccinated against COVID-19.
• Must commit to wearing the device at our location the whole day.
• Must not leave the building until sober - we have Wi-Fi and a nice office space; you can bring your personal phone or device to use.
• Must commit to not drinking before the study.
• Must show proof of age (license/passport).
• Must refrain from driving to our office.

If interested, please make sure you are free the whole day of the study. The exact time participants can leave is variable.

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