NCT03242161

Brief 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. The changes in interstitial alcohol concentrations will be compared to blood alcohol concentrations to determine the patch's validity against the gold standard.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
8

participants targeted

Target at below P25 for early_phase_1

Timeline
Completed

Started Jan 2018

Longer than P75 for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 1, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 8, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2024

Completed
Last Updated

January 5, 2024

Status Verified

January 1, 2024

Enrollment Period

6.3 years

First QC Date

August 1, 2017

Last Update Submit

January 3, 2024

Conditions

Alcohol Intoxication

Outcome Measures

Primary Outcomes (1)

  • 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.

    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.

Study Arms (1)

LabPatch-alcohol

EXPERIMENTAL

All subjects will be administered alcohol and then monitored by a non-invasive alcohol sensor

Diagnostic Test: LabPatch-alcohol

Interventions

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

LabPatch-alcohol

Eligibility Criteria

Age21 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McLean Hospital

Belmont, Massachusetts, 02478, United States

RECRUITING

MeSH Terms

Conditions

Alcoholic Intoxication

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Scott E Lukas, PhD

    Mclean Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Scott Lukas, PhD

CONTACT

617-855-2767slukas@mclean.harvard.edu

Wendy Tartarini, MA

CONTACT

617-855-2174wtartarini@mclean.harvard.edu

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, McLean Imaging Center

Study Record Dates

First Submitted

August 1, 2017

First Posted

August 8, 2017

Study Start

January 1, 2018

Primary Completion

April 30, 2024

Study Completion

April 30, 2024

Last Updated

January 5, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)