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

NCT05641389 | Recruiting

• 1 other identifier: 22-173
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Transdermal Alcohol Content

  Measurement produced while wearing Transdermal Alcohol Monitor

  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.

  Once every week for four weeks.

Study Arms (1)

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.

Other: Monitoring

Interventions

Monitoring OTHER

Participants will be monitored for alcohol use.

Monitoring Group

Eligibility Criteria

• Age: 21 Years+
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• ≥ 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).

Sponsors & Collaborators

• University of North Texas, Denton, TX: lead
• The University of Texas Health Science Center at San Antonio: collaborator

Study Sites (1)

University of North Texas

Denton, Texas, 76203, United States

RECRUITING

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Central Study Contacts

Jamie R Pogue

CONTACT

9403698308; Jamie.pogue@unt.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department Chair

Study Record Dates

• First Submitted: November 15, 2022
• First Posted: December 7, 2022
• Study Start: August 1, 2022
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: May 10, 2024

Record last verified: 2024-05

Locations

US (1)