Alcohol IntoxicationEarly Phase 1NCT03242161
Development of LabPatch-alcohol as a Noninvasive Skin Patch to Detect Blood Alcohol Concentrations
A Early Phase 1 study testing LabPatch-alcohol in people with Alcohol Intoxication, run by Mclean Hospital at 1 site in United States.
Trial summary
This study is designed to test LabPatch-alcohol, a wearable, non-invasive biosensor Band-Aid like patch that is designed to detect real-time changes in interstitial alcohol concentrations in human subjects. Read more about this study
- Who is it for?
- Ages 21 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Intoxication
- What is being tested?
- LabPatch-alcohol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2018to 11 Dec 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject is capable of understanding and complying with the protocol
- Good physical and mental health (normal physical exam, ECG, blood and urine chemistries, including absences of history or laboratory evidence of diabetes)
- Body Mass Index between 18-30, inclusive
- Age 21-50 years (age will be verified by driver's license or other valid form of identification)
- Have used alcohol, on average, between 5-15 drinks per week over the past 6 months.
- Have a stable living situation with current postal address
Who cannot join
- Meets criteria for current alcohol or substance use disorders (Past alcohol or substance use disorders greater than 3 years ago is acceptable)
- Concurrent diagnosis of Axis I disorder
- bMaintained on an antipsychotic or antidepressant medication; taking prescription medications except certain short-term anti-fungal agents and some tropical creams for dermal conditions
- Heavy alcohol drinkers (greater than 15 drinks per week)
- Tobacco use greater than 5 cigarettes per day
- History of major head trauma resulting in cognitive impairment or history of seizure disorder
Show all 9Show fewer
- Heavy caffeine use (greater than 500 mg on a regular daily basis)
- Subject has active hepatitis and/or aspartate aminotransferase (AST), alanine aminotransferase (ALT) > 3x the upper limit of normal
- For female volunteers, a positive pregnancy test
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of LabPatch-alcohol: A Wearable Biosensor for Detecting Alcohol in Interstitial Fluid
This study is designed to test LabPatch-alcohol, a wearable, non-invasive biosensor Band-Aid like patch that is designed to detect real-time changes in interstitial alcohol concentrations in human subjects. The changes in interstitial alcohol concentrations will be compared to blood alcohol concentrations to determine the patch's validity against the gold standard.
Read the detailed description
Nanotechnology has the potential to become a powerful tool in addiction medicine. The potential utility for passive, non-invasive wearable alcohol monitors is great and could play a major role in public safety as well as in both research, clinical, and treatment settings. Clinitech, LLC has developed LabPatch, an electronic bandage that continuously and imperceptibly samples interstitial fluid from the skin surface and measures relevant biomarkers in the fluid. The patch uses novel nanowire technology to sample the interstitial fluid from just underneath the skin and then uses an electrochemical reaction to measure either glucose or alcohol concentration. The participants' interstitial alcohol concentration (IAC) will be measured via LabPatch-alcohol at the same time points as blood samples so that a direct comparison can be made. Thus, the LabPatch-alcohol will be tested as the participant's BAC rises and falls through the legally intoxicated concentration (0.08%), and the goal is to match measures obtained via the prototype LabPatch-alcohol with whole blood alcohol concentrations. The LabPatch operational circuit lies on the underside of the bandage. The circuit surface is placed in contact with the skin by the application of the elastic adhesive bandage with a contact tension that provides modest pressure, as in the case of a conventional wound bandage. The temperature of the skin is measured electrically and the consistency of temperature is used to verify good contact and to monitor continued contact. The entire process takes 3-5 seconds to collect the sample, a pause for 1 sec and then 3 additional seconds to conduct the analysis.
- Conditions
- Alcohol Intoxication
- Being tested
- LabPatch-alcohol
- Medical subject headings
- Alcoholic Intoxication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LabPatch-alcoholDiagnostic test
a wearable, non-invasive biosensor Band-Aid like patch that is designed to detect real-time changes in interstitial alcohol concentrations in human subjects after they have consumed alcohol
| Study group | Role | What they receive |
|---|---|---|
| LabPatch-alcohol | Experimental | All subjects will be administered alcohol and then monitored by a non-invasive alcohol sensor Receives: Diagnostic Test: LabPatch-alcohol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interstitial and Blood Alcohol Concentrations
Interstitial (from the skin surface) alcohol concentrations will be obtained via the LabPatch band-aid while at the same time blood samples will be collected in an attempt to correlate the two. The LabPatch-alcohol is a completely noninvasive device and the goal is to determine is precision against the gold standard--blood alcohol concentrations.
Measured: Both samples will be collected at baseline and at 2.5 to 5 minute intervals for up to 2.5 hrs after a 0.9 g/kg dose of alcohol.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2017
- Study start1 Jan 2018
- Primary completion11 Dec 2026 (estimated)
- Study completion11 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol IntoxicationStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants assigned to have a lab patch-alcohol applied to skin and then receive a single dose of alcohol and then the patch measures how much alcohol appears in interstitial fluid. This is compared to the blood alcohol concentrations.
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mclean Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Scott Lukas, Mclean Hospital
- Investigators
- Scott E Lukas, PhD, Principal investigator, Mclean Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03242161
- Sponsor's protocol ID
- 2017P001502
- Status last verified
- Jul 2026
- First submitted
- 1 Aug 2017
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of LabPatch-alcohol: A Wearable Biosensor for Detecting Alcohol in Interstitial Fluid
- ClinicalTrials.gov ID
- NCT03242161
- Acronym / sponsor ID
- 2017P001502
- Conditions
- Alcohol Intoxication
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Mclean HospitalUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 11 Dec 2026 (estimated)
- Study completion
- 11 Dec 2026 (estimated)
- First posted
- 8 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to test LabPatch-alcohol, a wearable, non-invasive biosensor Band-Aid like patch that is designed to detect real-time changes in interstitial alcohol concentrations in human subjects. The changes in interstitial alcohol concentrations will be compared to blood alcohol concentrations to determine the patch's validity against the gold standard.
Detailed description
Nanotechnology has the potential to become a powerful tool in addiction medicine. The potential utility for passive, non-invasive wearable alcohol monitors is great and could play a major role in public safety as well as in both research, clinical, and treatment settings. Clinitech, LLC has developed LabPatch, an electronic bandage that continuously and imperceptibly samples interstitial fluid from the skin surface and measures relevant biomarkers in the fluid. The patch uses novel nanowire technology to sample the interstitial fluid from just underneath the skin and then uses an electrochemical reaction to measure either glucose or alcohol concentration. The participants' interstitial alcohol concentration (IAC) will be measured via LabPatch-alcohol at the same time points as blood samples so that a direct comparison can be made. Thus, the LabPatch-alcohol will be tested as the participant's BAC rises and falls through the legally intoxicated concentration (0.08%), and the goal is to match measures obtained via the prototype LabPatch-alcohol with whole blood alcohol concentrations. The LabPatch operational circuit lies on the underside of the bandage. The circuit surface is placed in contact with the skin by the application of the elastic adhesive bandage with a contact tension that provides modest pressure, as in the case of a conventional wound bandage. The temperature of the skin is measured electrically and the consistency of temperature is used to verify good contact and to monitor continued contact. The entire process takes 3-5 seconds to collect the sample, a pause for 1 sec and then 3 additional seconds to conduct the analysis.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants assigned to have a lab patch-alcohol applied to skin and then receive a single dose of alcohol and then the patch measures how much alcohol appears in interstitial fluid. This is compared to the blood alcohol concentrations.
| Arm | Type | Receives |
|---|---|---|
| LabPatch-alcohol | Experimental | Diagnostic Test: LabPatch-alcoholAll subjects will be administered alcohol and then monitored by a non-invasive alcohol sensor |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Subject is capable of understanding and complying with the protocol
- Good physical and mental health (normal physical exam, ECG, blood and urine chemistries, including absences of history or laboratory evidence of diabetes)
- Body Mass Index between 18-30, inclusive
- Age 21-50 years (age will be verified by driver's license or other valid form of identification)
- Have used alcohol, on average, between 5-15 drinks per week over the past 6 months.
Key exclusion criteria (9 listed)
- Meets criteria for current alcohol or substance use disorders (Past alcohol or substance use disorders greater than 3 years ago is acceptable)
- Concurrent diagnosis of Axis I disorder
- bMaintained on an antipsychotic or antidepressant medication; taking prescription medications except certain short-term anti-fungal agents and some tropical creams for dermal conditions
- Heavy alcohol drinkers (greater than 15 drinks per week)
- Tobacco use greater than 5 cigarettes per day
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 |
|---|---|---|
| LabPatch-alcohola wearable, non-invasive biosensor Band-Aid like patch that is designed to detect real-time changes in interstitial alcohol concentrations in human subjects after they have consumed alcohol | Diagnostic test | LabPatch-alcohol |
Primary outcome
Interstitial and Blood Alcohol Concentrations
Time frame: Both samples will be collected at baseline and at 2.5 to 5 minute intervals for up to 2.5 hrs after a 0.9 g/kg dose of alcohol.
Interstitial (from the skin surface) alcohol concentrations will be obtained via the LabPatch band-aid while at the same time blood samples will be collected in an attempt to correlate the two. The LabPatch-alcohol is a completely noninvasive device and the goal is to determine is precision against the gold standard--blood alcohol concentrations.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Scott E Lukas, PhD principal investigator
Mclean Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing LabPatch-alcohol in people with Alcohol Intoxication, run by Mclean Hospital 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 6 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 14 Jul 2026. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Interstitial and Blood Alcohol Concentrations (time frame: Both samples will be collected at baseline and at 2.5 to 5 minute intervals for up to 2.5 hrs after a 0.9 g/kg dose of alcohol.). 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 14 Jul 2026.