Drunk DrivingNCT03638596
Leveraging Transdermal Alcohol Monitoring to Reduce Drinking Among DWI Defendants
A study testing Contingency Management in people with Drunk Driving, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial summary
The current study will evaluate the efficacy of contingency management (i.e., reinforcement for avoiding heavy drinking) among adults arrested for drunk driving and who are at risk for ongoing heavy drinking. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Drunk Driving
- What is being tested?
- Contingency Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 158 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2017to 15 Mar 2021
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- arrested for drunk driving offense
Who cannot join
- significant alcohol withdrawal symptoms
- medical condition that would contraindicate participation (e.g., pregnancy, scheduled surgery)
- inability to comprehend the informed consent process or study instructions
- presence of a DSM-5 psychiatric disorder with symptoms of psychosis and/or delirium
- incarceration
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Health Science Center San Antonio
San Antonio, Texas, 78229
About this study
The current study will evaluate the efficacy of contingency management (i.e., reinforcement for avoiding heavy drinking) among adults arrested for drunk driving and who are at risk for ongoing heavy drinking.
Read the detailed description
Individuals who have a drunk driving arrest and are at risk for ongoing heavy drinking will be recruited to test the efficacy of contingency management for reducing alcohol use and identifying mechanisms of change. We will recruit those arrested for drunk driving offenses, ≥ 21 years of age, who at risk for ongoing heavy alcohol use and randomize them to one of two groups: control or a contingency management. Participants experience 8 weekly assessments of current alcohol use and other variables associated with changes in alcohol use. Post-intervention, participants will return to the laboratory once per month at 3, 6, 9, and 12 months post-study entry for follow-up procedures to determine the mechanisms of drinking behavior change.
- Conditions
- Drunk Driving
- Being tested
- Contingency Management, Control
- Keywords
- Alcohol Impaired Driving, Driving While Intoxicated, Driving Under the Influence, Driving While Impaired
- Medical subject headings
- Driving Under the Influence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contingency ManagementBehavioural
Incentive provided for changing alcohol drinking patterns based on ankle monitor
ControlBehavioural
Incentive provided is not contingent on alcohol drinking patterns based on ankle monitor
| Study group | Role | What they receive |
|---|---|---|
| Contingency Management | Experimental | Incentive delivery contingent upon maintaining transdermal alcohol concentration below cut-off Receives: Behavioral: Contingency Management |
| Control | Placebo comparator | Incentive delivery not contingent on transdermal alcohol concentration Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent heavy drinking days
Percent of days with estimated breath alcohol concentration .08% or higher or self-reported drinks > 5 for men and > 4 for women
Measured: 8-weeks
Secondary outcomes (4)
Percent drinking days
Percent of days with any positive transdermal alcohol concentration >.02 or any self-reported drinks
Measured: 8-weeks
Follow-up percent heavy drinking days
Self-reported drinks > 5 for men and > 4 for women
Measured: 12-months
Follow-up percent drinking days
Any self-reported drinks
Measured: 12-months
Measurement of alcohol biomarker
Change in phosphatidylethanol (PEth) using an assay on a blood sample
Measured: Baseline to 8-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2018
- Study start1 May 2017
- Primary completion15 Mar 2020
- Study completion15 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Drunk DrivingStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- random assignment to treatment and control arms
- Masking
- None (open label)
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Nathalie Hill-Kapturczak, PhD, Principal investigator, The University of Texas Health Science Center San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03638596
- Sponsor's protocol ID
- HSC20160425H
- Other IDs
- 5R01AA014988
- Status last verified
- May 2024
- First submitted
- 16 Aug 2018
- Last updated
- 7 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hill-Kapturczak N, Lamb RJ, Roache JD, Moon TJ, Liang Y, Dougherty DM. One month follow-up outcomes of a transdermal alcohol concentration-based contingency management intervention to reduce heavy drinking among driving while intoxicated arrestees. Alcohol Clin Exp Res (Hoboken). 2025 May;49(5):1166-1176. doi: 10.1111/acer.70047. Epub 2025 Mar 31.
PubMed 40165510
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leveraging Transdermal Alcohol Monitoring to Reduce Drinking Among DWI Defendants
- ClinicalTrials.gov ID
- NCT03638596
- Acronym / sponsor ID
- HSC20160425H
- Conditions
- Drunk Driving
- Keywords
- Alcohol Impaired Driving, Driving While Intoxicated, Driving Under the Influence, Driving While Impaired
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 1 May 2017 (actual)
- Primary completion
- 15 Mar 2020 (actual)
- Study completion
- 15 Mar 2021 (actual)
- First posted
- 20 Aug 2018 (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.
The current study will evaluate the efficacy of contingency management (i.e., reinforcement for avoiding heavy drinking) among adults arrested for drunk driving and who are at risk for ongoing heavy drinking.
Detailed description
Individuals who have a drunk driving arrest and are at risk for ongoing heavy drinking will be recruited to test the efficacy of contingency management for reducing alcohol use and identifying mechanisms of change. We will recruit those arrested for drunk driving offenses, ≥ 21 years of age, who at risk for ongoing heavy alcohol use and randomize them to one of two groups: control or a contingency management. Participants experience 8 weekly assessments of current alcohol use and other variables associated with changes in alcohol use. Post-intervention, participants will return to the laboratory once per month at 3, 6, 9, and 12 months post-study entry for follow-up procedures to determine the mechanisms of drinking behavior change.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- random assignment to treatment and control arms
| Arm | Type | Receives |
|---|---|---|
| Contingency Management | Experimental | Behavioral: Contingency ManagementIncentive delivery contingent upon maintaining transdermal alcohol concentration below cut-off |
| Control | Placebo comparator | Behavioral: ControlIncentive delivery not contingent on transdermal alcohol concentration |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- arrested for drunk driving offense
Key exclusion criteria (5 listed)
- significant alcohol withdrawal symptoms
- medical condition that would contraindicate participation (e.g., pregnancy, scheduled surgery)
- inability to comprehend the informed consent process or study instructions
- presence of a DSM-5 psychiatric disorder with symptoms of psychosis and/or delirium
- incarceration
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 |
|---|---|---|
| Contingency ManagementIncentive provided for changing alcohol drinking patterns based on ankle monitor | Behavioural | Contingency Management |
| ControlIncentive provided is not contingent on alcohol drinking patterns based on ankle monitor | Behavioural | Control |
Primary outcome
Percent heavy drinking days
Time frame: 8-weeks
Percent of days with estimated breath alcohol concentration .08% or higher or self-reported drinks > 5 for men and > 4 for women
4 secondary outcomes
Percent drinking days
Time frame: 8-weeks
Follow-up percent heavy drinking days
Time frame: 12-months
Follow-up percent drinking days
Time frame: 12-months
Measurement of alcohol biomarker
Time frame: Baseline to 8-weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2024.
- Derived from this study: PubMed 40165510Hill-Kapturczak N, Lamb RJ, Roache JD, Moon TJ, Liang Y, Dougherty DM. One month follow-up outcomes of a transdermal alcohol concentration-based contingency management intervention to reduce heavy drinking among driving while intoxicated arrestees. Alcohol Clin Exp Res (Hoboken). 2025 May;49(5):1166-1176. doi: 10.1111/acer.70047. Epub 2025 Mar 31.
- Individual participant dataSharing planned: No
Related trials for Drunk Driving
Recruiting
Evaluation of Global Smart Drinking Goals Initiative
Binge Drinking, Underage Drinking, Drinking and Driving, Alcohol-Related Harms
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.
Nathalie Hill-Kapturczak, PhD principal investigator
The University of Texas Health Science Center San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contingency Management in people with Drunk Driving, run by The University of Texas Health Science Center at San Antonio 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 1 inclusion and 5 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: finished, as of the sponsor's last update on 7 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent heavy drinking days (time frame: 8-weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03638596, which also lists 1 linked publication.
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 7 May 2024.