Alcohol DrinkingNCT03574181
Calibration Study of a Blood Alcohol Level Smart Watch
An observational study of Alcohol Drinking, run by Boston Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Drinking
- What is being tested?
- Smartwatch to measure Blood Alcohol Level (BAL)
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jul 2019to 17 Feb 2020
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Moderate (non-problem) drinking healthy volunteers
Who may be able to join
- 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
Who cannot join
- 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.
Show all 17Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston University Psychiatry Research Center, Clinical Studies Unit
Boston, Massachusetts, 02118
About this study
Official title: Calibration Study of a Wearable Noninvasive Blood Alcohol Monitor
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.
Read the detailed description
In this proposed study, the objective is to further demonstrate the reliability of this printed electrochemical gas sensor in the form of a wearable device. This demonstration of reliability among human subjects is an essential part of product development. The monitor will be in a wristband or watch form, similar to a smart watch. This device will be modern, attractive and comfortable. It will also have smart watch features including measuring key physiological parameters (e.g., pulse) and eventually will have connectivity to apps on smart phones and other devices. The aim of the work is to provide a new, noninvasive transdermal alcohol monitor into the market. The transdermal alcohol monitoring market has few wearable products available and innovation has been lacking in this field. This new product will take advantage of current trends in wearable technology. As the public becomes more comfortable with wearable sensors, the blood alcohol monitor will become popular with people interested in health and fitness who want to track their alcohol intake. The product will provide a new, highly reliable and sensitive method for tracking blood alcohol level. This may be particularly beneficial to individuals who seek to reduce the risk of alcohol use by limiting peak blood alcohol level. If successful, this technology could be adopted in many areas including clinical and medical treatment, employee wellness programs, alcohol clinical trials, and as part of brief interventions that target at-risk drinkers.
The specific objective of this study is to determine whether the printed electrochemical gas sensor designed to measure blood alcohol level will be sensitive and reliable when compared to a standard measure of blood alcohol level taken by a breathalyzer. If this sensor proves sensitive to changes in blood alcohol level and can reliably measure blood alcohol level relative to a "gold standard" method, there are significant opportunities to use this technology in consumer health applications and clinical research.
- Conditions
- Alcohol Drinking
- Being tested
- Smartwatch to measure Blood Alcohol Level (BAL)
- Keywords
- Wrist watch blood alcohol level, Blood alcohol, Objective alcohol measure
- Medical subject headings
- Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 hours during alcohol self administration trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2018
- Study start8 Jul 2019
- Primary completion17 Feb 2020
- Study completion17 Feb 2020
Why it stopped: Extensive changes to the watch design would be needed to produce a robust device.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alcohol DrinkingStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- KWJ Engineering, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Eric Devine, Boston Medical Center
- Investigators
- Eric Devine, PhD, Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03574181
- Sponsor's protocol ID
- H-36914
- Other IDs
- R44AA024651-02
- Status last verified
- Feb 2021
- First submitted
- 20 Jun 2018
- Last updated
- 18 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Calibration Study of a Wearable Noninvasive Blood Alcohol Monitor
- ClinicalTrials.gov ID
- NCT03574181
- Acronym / sponsor ID
- H-36914
- Conditions
- Alcohol Drinking
- Keywords
- Wrist watch blood alcohol level, Blood alcohol, Objective alcohol measure
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Extensive changes to the watch design would be needed to produce a robust device.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- KWJ Engineering, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 8 Jul 2019 (actual)
- Primary completion
- 17 Feb 2020 (actual)
- Study completion
- 17 Feb 2020 (actual)
- First posted
- 29 Jun 2018 (actual)
- Results
- Posted 18 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In this proposed study, the objective is to further demonstrate the reliability of this printed electrochemical gas sensor in the form of a wearable device. This demonstration of reliability among human subjects is an essential part of product development. The monitor will be in a wristband or watch form, similar to a smart watch. This device will be modern, attractive and comfortable. It will also have smart watch features including measuring key physiological parameters (e.g., pulse) and eventually will have connectivity to apps on smart phones and other devices. The aim of the work is to provide a new, noninvasive transdermal alcohol monitor into the market. The transdermal alcohol monitoring market has few wearable products available and innovation has been lacking in this field. This new product will take advantage of current trends in wearable technology. As the public becomes more comfortable with wearable sensors, the blood alcohol monitor will become popular with people interested in health and fitness who want to track their alcohol intake. The product will provide a new, highly reliable and sensitive method for tracking blood alcohol level. This may be particularly beneficial to individuals who seek to reduce the risk of alcohol use by limiting peak blood alcohol level. If successful, this technology could be adopted in many areas including clinical and medical treatment, employee wellness programs, alcohol clinical trials, and as part of brief interventions that target at-risk drinkers.
The specific objective of this study is to determine whether the printed electrochemical gas sensor designed to measure blood alcohol level will be sensitive and reliable when compared to a standard measure of blood alcohol level taken by a breathalyzer. If this sensor proves sensitive to changes in blood alcohol level and can reliably measure blood alcohol level relative to a "gold standard" method, there are significant opportunities to use this technology in consumer health applications and clinical research.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Moderate (non-problem) drinking healthy volunteers
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smartwatch to measure Blood Alcohol Level (BAL)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. | Other | – |
Primary outcome
Correlation Between Breathalyzer and Wristwatch Sensor BAL Measurements
Time frame: 6 hours during alcohol self administration trial
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
Related trials for Alcohol Drinking
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingPhase 1
Environment and Alcohol: A Pilot Study
Alcohol Use Disorder
Not yet recruiting
A MRT to Optimize a JITAI for Alcohol Craving and Suicide Ideation
Alcohol Use Disorder (AUD), Suicide Ideation
RecruitingPhase 2
Study on Thiamine Supplementation to REduce braiN Injury Associated With Chronic Alcohol Use in Outpatients With Alcohol Use Disorder
Alcohol Use Disorder
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Devine, PhD principal investigator
Boston Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alcohol Drinking, run by Boston Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation Between Breathalyzer and Wristwatch Sensor BAL Measurements (time frame: 6 hours during alcohol self administration trial). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2021.