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.
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.
United States1 site, 1 recruiting
- Recruiting
University of North Texas
Denton, Texas, 76203
Jamie R Pogue, BA, 940-369-8308, Jamie.Pogue@unt.edu
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.
- Conditions
- Alcohol Monitoring, Alcohol Use Disorder
- 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 group | Role | What they receive |
|---|---|---|
| Monitoring Group | Participants 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.
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.
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.
- First posted7 Dec 2022
- Study start1 Aug 2022
- Primary completion31 Jul 2024 (estimated)
- Study completion31 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol MonitoringStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of North Texas, Denton, TX
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Donald Dougherty, University of North Texas, Denton, TX
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
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Remote Breathalyzer Procedures Used by Clinicians and Researchers to Remotely Monitor Alcohol Use
- ClinicalTrials.gov ID
- NCT05641389
- Acronym / sponsor ID
- 22-173
- Conditions
- Alcohol Monitoring, Alcohol Use Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of North Texas, Denton, TXUniversity, hospital or other
- Collaborators
- The University of Texas Health Science Center at San Antonio
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 31 Jul 2024 (estimated)
- First posted
- 7 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Monitoring Group | – | Other: MonitoringParticipants 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study population is consisted of members of the DFW metroplex.
Key inclusion criteria (2 listed)
- •≥ 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).
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MonitoringParticipants will be monitored for alcohol use. | Other | Monitoring Group |
Primary outcome
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.
Measurement produced while wearing Transdermal Alcohol Monitor
Measurement of Phosphatidylethanol
Time frame: Once every week for four weeks.
Measuring Phosphatidylethanol via blood spot cards. THis is a measurement of alcohol use.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2024.
Related trials for Alcohol Monitoring
RecruitingObservational study
SMART-r: Substance Monitoring and Active Relapse Tracking Repository
Alcoholism, Substance-Related Disorders
Not yet recruiting
Effectiveness of Nurse-Conducted Brief Intervention (NCBI) Supplemented With Mobile for Preventing Alcohol Use Disorders
Alcohol Use Disorder (AUD)
Recruiting
Investigating the Effect of Caffeine and Alcohol on Pupil Dynamics
Caffeine, Alcohol
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
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.