Improving Remote Breathalyzer Procedures Used by Clinicians and Researchers to Remotely Monitor Alcohol Use
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Contacts and Locations
Study Contact
Study Contact
- Name: Jamie R Pogue
- Phone Number: 9403698308
- Email: Jamie.pogue@unt.edu
Study Locations
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Texas
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Denton, Texas, United States, 76203
- Recruiting
- University of North Texas
-
Contact:
- Jamie R Pogue, BA
- Phone Number: 940-369-8308
- Email: Jamie.Pogue@unt.edu
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Number of groups / cohorts
Cohorts and Interventions
Group / CohortGroup / Cohort |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
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.
|
Participants will be monitored for alcohol use.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
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.
|
Measuring Phosphatidylethanol via blood spot cards.
THis is a measurement of alcohol use.
|
Once every week for four weeks.
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 22-173
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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