Alcoholic IntoxicationBADSNCT00575679
Behavior and Driving Safety Study
A study testing Brief motivational interview in people with Alcoholic Intoxication, run by University of California, Davis at 1 site in United States.
Trial summary
The purpose of this study is to determine whether brief motivational interviews reduce the likelihood of driving under the influence of alcohol (DUI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcoholic Intoxication
- What is being tested?
- Brief motivational interview
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 864 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to 20 Feb 2014
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Second or greater arrest for driving under the influence of alcohol
- Arrest involved operation of a motor vehicle
- At least 18 years of age
- English-speaking
Who cannot join
- Arrest involved injury to another person
- Previous participation in this study
Trial locations and contacts
1 site in 1 country.
United States1 site
Sacramento County Main Jail
Sacramento, California, 95814
About this study
The purpose of this study is to determine whether brief motivational interviews reduce the likelihood of driving under the influence of alcohol (DUI).
Read the detailed description
Despite extensive legislative, law enforcement, and public awareness efforts, driving under the influence of alcohol (DUI) remains a major cause of mortality and loss of years of productive life. A brief motivational interview (BI) is a non-confrontational, patient-centered discussion during which the individual's motivation and confidence to change health-related behaviors are explored. Previous studies of BIs in health care settings suggest that BIs administered after hospitalization for alcohol-related injury reduce the likelihood of repeat injury hospitalization and arrest for DUI.
- Conditions
- Alcoholic Intoxication
- Being tested
- Brief motivational interview
- Keywords
- Automobile driving, Driving under the influence, Interview, psychological, Brief intervention, Brief motivational interview
- Medical subject headings
- Alcoholic Intoxication, Driving Under the Influence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief motivational interviewBehavioural
The brief motivational interview is a non-confrontational, patient-centered discussion between a counselor (e.g., social worker, nurse, physician, or psychologist) and an at-risk individual during which the individual's motivation and confidence to change health-related behaviors are explored.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Brief motivational interview Receives: Behavioral: Brief motivational interview |
| 2 | No intervention | No discussion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to repeat arrest for driving under the influence of alcohol
Measured: Up until one year after the conclusion of enrollment
Secondary outcomes (2)
Alcohol Use Disorders Identification Test score
Measured: 6 and 12 months
Time to alcohol-related injury hospitalization
Measured: Up until one year after the conclusion of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2007 (estimated)
- Study startJan 2008
- Primary completion20 Feb 2014
- Study completion20 Feb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcoholic IntoxicationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 864 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- Sacramento Police Department, California Office of Traffic Safety, University of Michigan, Robert Wood Johnson Foundation, Teachable Moment Foundation
- Responsible party
- Sponsor
- Investigators
- Garth H Utter, MD MSc, Principal investigator, University of California, DavisLeon J Owens, MD, Study director, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00575679
- Sponsor's protocol ID
- 243197
- Other IDs
- UCDIRB-200614967, OTS-AL0757
- Acronym
- BADS
- Status last verified
- Jan 2019
- First submitted
- 14 Dec 2007
- Last updated
- 4 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavior and Driving Safety Study
- ClinicalTrials.gov ID
- NCT00575679
- Acronym / sponsor ID
- BADS / 243197
- Conditions
- Alcoholic Intoxication
- Keywords
- Automobile driving, Driving under the influence, Interview, psychological, Brief intervention, Brief motivational interview
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 864 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- Sacramento Police Department, California Office of Traffic Safety, University of Michigan, Robert Wood Johnson Foundation, Teachable Moment Foundation
- Study start
- Jan 2008 (actual)
- Primary completion
- 20 Feb 2014 (actual)
- Study completion
- 20 Feb 2014 (actual)
- First posted
- 18 Dec 2007 (estimated)
- 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 purpose of this study is to determine whether brief motivational interviews reduce the likelihood of driving under the influence of alcohol (DUI).
Detailed description
Despite extensive legislative, law enforcement, and public awareness efforts, driving under the influence of alcohol (DUI) remains a major cause of mortality and loss of years of productive life. A brief motivational interview (BI) is a non-confrontational, patient-centered discussion during which the individual's motivation and confidence to change health-related behaviors are explored. Previous studies of BIs in health care settings suggest that BIs administered after hospitalization for alcohol-related injury reduce the likelihood of repeat injury hospitalization and arrest for DUI.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Brief motivational interviewBrief motivational interview |
| 2 | No intervention | –No discussion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Second or greater arrest for driving under the influence of alcohol
- Arrest involved operation of a motor vehicle
- At least 18 years of age
- English-speaking
Key exclusion criteria (2 listed)
- Arrest involved injury to another person
- Previous participation in this study
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 |
|---|---|---|
| Brief motivational interviewThe brief motivational interview is a non-confrontational, patient-centered discussion between a counselor (e.g., social worker, nurse, physician, or psychologist) and an at-risk individual during which the individual's motivation and confidence to change health-related behaviors are explored. | Behavioural | 1 |
Primary outcome
Time to repeat arrest for driving under the influence of alcohol
Time frame: Up until one year after the conclusion of enrollment
2 secondary outcomes
Alcohol Use Disorders Identification Test score
Time frame: 6 and 12 months
Time to alcohol-related injury hospitalization
Time frame: Up until one year after the conclusion of enrollment
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 4 Jan 2019.
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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.
Garth H Utter, MD MSc principal investigator
University of California, Davis
Leon J Owens, MD study director
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief motivational interview in people with Alcoholic Intoxication, run by University of California, Davis 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 4 inclusion and 2 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 4 Jan 2019. 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?
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?
Time to repeat arrest for driving under the influence of alcohol (time frame: Up until one year after the conclusion of enrollment). 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 4 Jan 2019.