A Pilot Study on use of the Smart Start wrist alcohol monitor to estimate physiological alcohol concentration trajectories.

A
Ann Kosobud

Primary Investigator

Overview

The purpose of the study is to characterize the output of the BARE transdermal alcohol sensor against a known alcohol exposure trajectory in several healthy subjects.  To achieve this objective, subjects will be given a controlled alcohol infusion that raises their breath alcohol level to 60 mg/dL and holds it there for 3 hours.  Alcohol concentration levels will be measured in serial samples of breath and venous blood, and compared to transdermal alcohol concentration measurements obtained from the BARE device, and to CAIS physiologically-based pharmacokinetic modelling of breath, blood and tissue compartments.

Description

 

Eligibility

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Healthy volunteers,1908749958
  • Age: Between 21 Years - 55 Years
  • Gender: All

Inclusion:
Overtly healthy men and women aged 21 – 55
At least 5 (for women) and 7 (for men) drinks/week on average and at least 2 drinks on a drinking day a minimum of three times over the last 5 weeks
Able to understand/complete questionnaires and procedures in English
Have venous access sufficient to allow blood sampling and the IV alcohol challenge procedure
Able to participate on predetermined alcohol infusion days.
 
Exclusion:
Pregnant or breast-feeding women
Desire to be treated for any substance use disorder or court ordered to not drink alcohol
Medical disorders or other conditions such as alcohol withdrawal seizures or delirium tremens that may influence study outcome or subject safety
Positive urine drug screen for amphetamines/ methamphetamines, barbiturates, benzodiazapines, cocaine, opiates, or phencyclidine if determined by the PI to adversely affect subject safety or data integrity
Medications (past 30 days) that could influence subject data/subject safety (e.g. antidepressants, antipsychotics, benzodiazepines, etc.) as determined by Dr. Plawecki
DSM-5 Disorders (non AUD) or current/history of neurological disease of cerebral origin, or head injury with > 20 min loss of consciousness, if determined by the principal investigators to affect subject safety or data integrity.
Positive BrAC reading at beginning of any study session
Actively suicidal (for example, any suicide attempts within the past year or any current suicidal intent, including a plan) or are at serious suicidal risk, by clinical judgment of the investigator
Any condition for which the principal investigators determine it is unsafe or not prudent to enroll a subject.

Additional Information:

Updated on 20 Nov 2022. Study ID: 1908749958

Interested in the study?

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