Calibration Study of a Blood Alcohol Level Smart Watch

NCT03574181 | Terminated Results

• 2 other identifiers: H-36914R44AA024651-02
• Study Type: observational
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Drinking

Keywords

Wrist watch blood alcohol level; Blood alcohol; Objective alcohol measure

Outcome Measures

Primary Outcomes (1)

• Correlation Between Breathalyzer and Wristwatch Sensor BAL Measurements

  Wristwatch sensor BAL is continuously measured for entirety of 6-hour alcohol self administration trial. BAL from breathalyzer (BrAC) is measured at 15-minute intervals throughout 6-hour alcohol self administration trial. The correlation between wristwatch transdermal BAL (TAC) and breathalyzer BAL (BrAC) for all subjects will be calculated.

  6 hours during alcohol self administration trial

Interventions

Smartwatch to measure Blood Alcohol Level (BAL) OTHER

Subjects will wear a wristwatch with a sensor that measures blood alcohol level during a 1-hour period of consuming alcohol followed by a 5 hour observation period.

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Moderate (non-problem) drinking healthy volunteers

You may qualify if:

• 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.

Sponsors & Collaborators

• Boston Medical Center: lead
• KWJ Engineering: collaborator
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Boston University Psychiatry Research Center, Clinical Studies Unit

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Alcohol Drinking

Interventions

Ethanol; Floors and Floorcoverings

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals; Facility Design and Construction; Architecture; Technology, Industry, and Agriculture

Limitations and Caveats

The large variability in response characteristics between individuals and the complexity of model development in the face of the large BrAC - TAC lag times presented challenges to further development and completion of phase 2 of this study.

Results Point of Contact

• Title: Dr. Eric Devine
• Organization: Boston Medial Center

eric.devine@bmc.org

617-638-7888

Study Officials

• Eric Devine, PhD

  Boston Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Dept of Psychiatry

Study Record Dates

• First Submitted: June 20, 2018
• First Posted: June 29, 2018
• Study Start: July 8, 2019
• Primary Completion: February 17, 2020
• Study Completion: February 17, 2020
• Last Updated: February 18, 2021
• Results First Posted: February 18, 2021

Record last verified: 2021-02

Locations

US (1)