Alcoholic IntoxicationNCT01270217
Behavior and Driving Safety Study II
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 problematic drinking behavior among individuals arrested for the first time for 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
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to Dec 2015
- 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
- First 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
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 problematic drinking behavior among individuals arrested for the first time for 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. This study will evaluate whether brief motivational interviews reduce problematic drinking behavior among individuals arrested for the first time for driving under the influence of alcohol (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 |
|---|---|---|
| Brief motivational interview | Experimental | Not described Receives: Behavioral: Brief motivational interview |
| No discussion | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol Use Disorders Identification Test score
Measured: 3 months
Secondary outcomes (1)
Time to repeat arrest for driving under the influence of alcohol
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 posted5 Jan 2011 (estimated)
- Study startDec 2010
- Primary completionDec 2015
- Study completionDec 2015
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 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
- 200 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
- Responsible party
- Sponsor
- Investigators
- Garth H Utter, MD MSc, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01270217
- Sponsor's protocol ID
- 201018332
- Status last verified
- Jul 2017
- First submitted
- 3 Jan 2011
- Last updated
- 11 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Utter GH, Young JB, Theard LA, Cropp DM, Mohar CJ, Eisenberg D, Schermer CR, Owens LJ. The effect on problematic drinking behavior of a brief motivational interview shortly after a first arrest for driving under the influence of alcohol: a randomized trial. J Trauma Acute Care Surg. 2014 Mar;76(3):661-70; discussion 670-1. doi: 10.1097/TA.0000000000000144.
PubMed 24553532
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavior and Driving Safety Study II
- ClinicalTrials.gov ID
- NCT01270217
- Acronym / sponsor ID
- 201018332
- Conditions
- Alcoholic Intoxication
- Keywords
- Automobile driving, Driving under the influence, Interview, psychological, Brief intervention, Brief motivational interview
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- Sacramento Police Department, California Office of Traffic Safety
- Study start
- Dec 2010 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 5 Jan 2011 (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 problematic drinking behavior among individuals arrested for the first time for 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. This study will evaluate whether brief motivational interviews reduce problematic drinking behavior among individuals arrested for the first time for driving under the influence of alcohol (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 |
|---|---|---|
| Brief motivational interview | Experimental | Behavioral: Brief motivational interview |
| No discussion | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- First 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 (1 listed)
- Arrest involved injury to another person
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 | Brief motivational interview |
Primary outcome
Alcohol Use Disorders Identification Test score
Time frame: 3 months
1 secondary outcome
Time to repeat arrest for driving under the influence of alcohol
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 11 Jul 2017.
- Derived from this study: PubMed 24553532Utter GH, Young JB, Theard LA, Cropp DM, Mohar CJ, Eisenberg D, Schermer CR, Owens LJ. The effect on problematic drinking behavior of a brief motivational interview shortly after a first arrest for driving under the influence of alcohol: a randomized trial. J Trauma Acute Care Surg. 2014 Mar;76(3):661-70; discussion 670-1. doi: 10.1097/TA.0000000000000144.
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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
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 1 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 11 Jul 2017. 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?
Alcohol Use Disorders Identification Test score (time frame: 3 months). 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 NCT01270217, 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 11 Jul 2017.