RECRUITING

Development of LabPatch-alcohol as a Noninvasive Skin Patch to Detect Blood Alcohol Concentrations

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Conditions

Alcohol Intoxication

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Development of LabPatch-alcohol: A Wearable Biosensor for Detecting Alcohol in Interstitial Fluid

Quick Facts

Study Start:2018-01-01
Study Completion:2024-04-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03242161

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 50 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Subject is capable of understanding and complying with the protocol
  2. * Good physical and mental health (normal physical exam, ECG, blood and urine chemistries, including absences of history or laboratory evidence of diabetes)
  3. * Body Mass Index between 18-30, inclusive
  4. * Age 21-50 years (age will be verified by driver's license or other valid form of identification)
  5. * Have used alcohol, on average, between 5-15 drinks per week over the past 6 months.
  6. * Have a stable living situation with current postal address
  1. * Meets criteria for current alcohol or substance use disorders (Past alcohol or substance use disorders greater than 3 years ago is acceptable)
  2. * Concurrent diagnosis of Axis I disorder
  3. * bMaintained on an antipsychotic or antidepressant medication; taking prescription medications except certain short-term anti-fungal agents and some tropical creams for dermal conditions
  4. * Heavy alcohol drinkers (greater than 15 drinks per week)
  5. * Tobacco use greater than 5 cigarettes per day
  6. * History of major head trauma resulting in cognitive impairment or history of seizure disorder
  7. * Heavy caffeine use (greater than 500 mg on a regular daily basis)
  8. * Subject has active hepatitis and/or aspartate aminotransferase (AST), alanine aminotransferase (ALT) \> 3x the upper limit of normal
  9. * For female volunteers, a positive pregnancy test

Contacts and Locations

Study Contact

Scott Lukas, PhD
CONTACT
617-855-2767
slukas@mclean.harvard.edu
Wendy Tartarini, MA
CONTACT
617-855-2174
wtartarini@mclean.harvard.edu

Principal Investigator

Scott E Lukas, PhD
PRINCIPAL_INVESTIGATOR
Mclean Hospital

Study Locations (Sites)

McLean Hospital
Belmont, Massachusetts, 02478
United States

Collaborators and Investigators

Sponsor: Mclean Hospital

  • Scott E Lukas, PhD, PRINCIPAL_INVESTIGATOR, Mclean Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-01-01
Study Completion Date2024-04-30

Study Record Updates

Study Start Date2018-01-01
Study Completion Date2024-04-30

Terms related to this study

Additional Relevant MeSH Terms

  • Alcohol Intoxication