Recruiting

Remote Breathalyzer

Sponsor:

University of North Texas, Denton, TX

Code:

NCT05641389

Conditions

Alcohol Monitoring

Alcohol Use Disorder

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

Monitoring

Study Details

Brief 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.

Conditions

Alcohol Monitoring

Alcohol Use Disorder

Study ID

NCT05641389

Start date

Aug 1, 2022

Status verified date

May, 2024

Completion date

Jul 31, 2024

Anticipated

Primary completion date

Jul 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Inclusion Criteria:

•≥ 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).

Study Design

Enrollment

60 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Monitoring

Participants will be monitored for alcohol use.

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. ]
  • Measurement of Phosphatidylethanol [ Time Frame: Once every week for four weeks. ]

Central Contacts and Locations

Central contacts

Locations

University of North Texas

Recruiting

Denton, Texas, United States, 76203

Contacts

More Information

Sponsor

University of North Texas, Denton, TX

Last update posted

May 10, 2024

Last verified

May, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of North Texas, Denton, TX on 2024-05-10.