Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05641389 |
| Other study ID # |
22-173 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
August 1, 2022 |
| Est. completion date |
July 31, 2024 |
Study information
| Verified date |
May 2024 |
| Source |
University of North Texas, Denton, TX |
| Contact |
Jamie R Pogue |
| Phone |
9403698308 |
| Email |
Jamie.pogue[@]unt.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Remote breath alcohol monitors have been increasingly adopted for use in clinical, research
and forensic settings to monitor alcohol use because they offer several key advantages over
other available monitoring methods. However, it remains unknown if remote breathalyzers
reliably detect alcohol use because there is up to a 10-hour window of time when breath
samples are not obtained (to allow for sleeping). Additionally, the investigators will
examine whether a supplemental measurement of a blood alcohol use biomarker
(phosphatidylethanol) can confirm abstinence and/or detect individuals engaging in
late-evening drinking to avoid the negative consequences associated with detected alcohol
use.
Description:
Devices that can continuously and/or remotely monitor alcohol use have created new
opportunities for both research and intervention, initially with transdermal alcohol monitors
(TAMs) that continuously and remotely detect alcohol excreted through the skin. TAMs were
first designed and used in the criminal justice system, but their disadvantages have limited
widespread adoption (e.g., availability, cost, size, interference with physical activities,
and stigma) (Allessi et al., 2017; Caluzzi et al., 2019). Thus, other alcohol monitoring
technologies (and procedures) to detect and characterize alcohol consumption are being
developed and used. One example is remote breathalyzers (e.g., SCRAM Remote Breath®), a
potential alternative to TAMs. They are small, can be used daily and more privately, use
Automated Facial Intelligence™ (AFI™) technology to verify identity, and have safeguards to
prevent circumvention (SCRAM, 2020). Heavy drinking may go undetected when using prescribed
remote breathalyzer monitoring protocols. Remote breathalyzers are being used more frequently
in legal and clinical research settings (e.g., Alessi & Petry, 2013; Koffarnus et al., 2018;
Moody et al., 2018; Nehlin et al., 2018; Recovery Healthcare Corporation, personal
communication, June 22, 2021; Skipper et al., 2014). The underlying assumption is that
breathalyzers objectively detect alcohol consumption. In fact, among social drinkers (n =
12), remote breath alcohol concentration (BrAC) monitoring protocols had a 98.8% rate of
correspondence with self-reported drinking (Skipper et al., 2014), where there were no
drinking-associated contingencies/consequences. Manufacturer monitoring protocols have not
been validated among individuals who do have contingencies/ consequences associated with
detected drinking. Remote breath sampling protocols may provide ample opportunity for
individuals to drink heavily, especially among populations where detected drinking is
associated with penalties. Importantly, when contingencies are present, individuals may adopt
or adjust their drinking patterns to "beat" the system. For instance, procedures used in the
judicial system (which correspond with manufacturer recommendations), individuals are
prompted to submit 4 breath samples/day, beginning at a start time chosen by the person being
monitored and then every 5 hours thereafter (e.g., 7am, 12pm, 5pm, 10pm). Each person's
schedule for sampling is the same every day and breath samples must be submitted within an
hour after prompting. Therefore, these schedules have "on- and off-cycle" times, with the
on-cycle schedule covering only ~15 hours of each day. The off-cycle schedule, from the
submission of the last sample on one day to the first sample the next day, allows time for
sleep, but during this time (up to 10 hours, including an allowance for the sampling window)
drinking could occur. People could drink right after their last breath sample (e.g., 10pm)
and still submit a negative BrAC (<.02 g/dL) the next day (required by 8am). BrAC ≥.02 g/dL
are considered positive for alcohol use (NHTSA, 2018). Based on our prior alcohol
self-administration study, at varying levels of intoxication, both men and women could be
below .02 g/dL within ~6 hours (Figure 1; Hill-Kapturczak et al., 2015), showing considerable
latitude for engaging in drinking and not violating monitoring criteria. Thus, it is unknown
if remote BrAC monitors can yield reliable and valid measures of drinking events in those
who: (a) may find it difficult to control drinking, and (b) are motivated to avoid detection
of drinking due to consequences.
