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Alcohol MonitoringNCT05641389

Improving Remote Breathalyzer Procedures Used by Clinicians and Researchers to Remotely Monitor Alcohol Use

An observational study of Alcohol Monitoring and Alcohol Use Disorder, run by University of North Texas, Denton, TX at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
Alcohol Monitoring, Alcohol Use Disorder
What is being tested?
Monitoring
How many people
60 participants
Where
1 siteUnited States
Study dates
1 Aug 2022to 31 Jul 2024
Phase
Observational
Are there results?
None posted in the registry

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 years and older
  • All sexes
  • Adult, Older adult

Study population: The study population is consisted of members of the DFW metroplex.

Who may be able to join

  • •≥ 21 years of age
  • •Either convicted of a DWI offense in the past 2 years but not court-mandated to undergo continuous alcohol monitoring or reporting driving while intoxicated in the past year or report ≥ 10 heavy drinking episodes during the past month (heavy drinking episodes count as more than 3 drinks in a day for females and 4 or more alcoholic drinks in a day in a male).

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Jamie R Pogue contact

9403698308

Jamie.pogue@unt.edu

United States1 site, 1 recruiting
  • University of North Texas

    Denton, Texas, 76203

    Jamie R Pogue, BA, 940-369-8308, Jamie.Pogue@unt.edu

    Recruiting

Other trials in United States

About this study

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.

Read the detailed 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.

Being tested
Monitoring
Medical subject headings
Alcoholism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MonitoringOther

    Participants will be monitored for alcohol use.

Study groups in NCT05641389
Study groupRoleWhat they receive
Monitoring GroupParticipants will be monitored via a transdermal monitor for four weeks. They will give four breath samples a day for these weeks as well as 5 Blood spot samples.
Receives: Other: Monitoring

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Transdermal Alcohol Content

    Measurement produced while wearing Transdermal Alcohol Monitor

    Measured: They will be placed on the device starting at the first visit and wear it for four weeks till the last visit.

  2. Measurement of Phosphatidylethanol

    Measuring Phosphatidylethanol via blood spot cards. THis is a measurement of alcohol use.

    Measured: Once every week for four weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Dec 2022
  2. Study start1 Aug 2022
  3. Primary completion31 Jul 2024 (estimated)
  4. Study completion31 Jul 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05641389
Sponsor's protocol ID
22-173
Status last verified
May 2024
First submitted
15 Nov 2022
Last updated
10 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Alcohol Monitoring and Alcohol Use Disorder, run by University of North Texas, Denton, TX 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 2 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 10 May 2024. 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.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jamie R Pogue (9403698308, Jamie.pogue@unt.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Transdermal Alcohol Content (time frame: They will be placed on the device starting at the first visit and wear it for four weeks till the last visit.). The study lists 2 primary outcomes in all. 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 10 May 2024.

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