Alcohol DrinkingNCT00278785
Brief Intervention for Alcohol Use Among Injured Patients
A study testing Brief Motivational Interview in people with Alcohol Drinking and Wounds and Injuries, run by University of California, Davis at 1 site in United States.
Trial summary
The underlying hypothesis that providing brief interventions to individuals who engage in potentially harmful patterns of alcohol use will alter their drinking behavior and therefore avoid negative consequences. Specifically, this study aims to determine if brief interventions will: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Drinking, Wounds and Injuries
- 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
- 830 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to 24 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- >=18 yrs old
- English or Spanish Speaking
- Mentally and physically able to provide consent and participate in the intervention
- Admission to the trauma ward or ICU
Who cannot join
- <18 yrs old
- Non-English or Non-Spanish Speaking
- Severe Psychiatric illness
- incarcerated
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Davis, Medical Center
Sacramento, California, 95817
About this study
Official title: Brief Intervention for Alcohol Use Among Injured Patients: A Prospective, Randomized Trial
The underlying hypothesis that providing brief interventions to individuals who engage in potentially harmful patterns of alcohol use will alter their drinking behavior and therefore avoid negative consequences. Specifically, this study aims to determine if brief interventions will:
- Reduce the number of re-admissions and deaths due to injuries associated with alcohol consumption
- Reduce the number of driving under the influence (DUI) arrests
- Reduce harmful drinking behavior
Read the detailed description
Alcohol use is the most common underlying cause of injuries in the United States. There is a growing body of literature suggesting that brief interventions (BI), in the form of a short (10-60 minute) counseling session, may decrease alcohol consumption and its harmful consequences. In contrast to the abundant literature on the effectiveness of BI in the outpatient setting, only 3 randomized controlled trials have been performed an adults specifically in the setting of acute trauma, and have had inconclusive results. All three studies used highly trained persons to perform the BI, and all were greater than 30 minutes in duration, a situation that may not necessarily reflect the practicalities of routine medical care. This raises the question of whether the benefits seen in these studies reflect the expertise of a small number of individuals or whether the effects correlate with the amount of time spent with the patient. Highly trained personnel and time are valuable commodities in a busy trauma center and may not be feasible given the competing clinical demands. We propose to investigate whether BI are effective in a setting that is more likely to reflect "real world" of clinical medicine rather than an idealized setting, utilizing trauma nurse practitioners to perform brief (5-10 minute) interviews.
We will identify all patients admitted with trauma who test positive on a blood alcohol test. These patients will be consented and randomized to either a brief intervention group, or a standard medical care group. All patients will receive an AUDIT questionnaire to identify patterns of drinking behavior and an alcohol information pamphlet. After discharge, patients will be telephoned at 1,6, and 12 months. The first 2 contacts will be to see how the patient is doing and to verify the contact information. The AUDIT questionnaire will be re-administered during the 12 month interview.
- Conditions
- Alcohol Drinking, Wounds and Injuries
- Being tested
- Brief Motivational Interview
- Keywords
- interviews, brief intervention, drinking, alcohol, injuries, wounds, intervention studies
- Medical subject headings
- Alcohol Drinking, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Motivational InterviewBehavioural
Also called Brief intervention, Motivational interview
10-20 minute brief motivational interview
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | Control group to receive informational pamphlet on alcohol use and list of self referral agencies |
| 2 | Experimental | Intervention group receives pamphlet on alcohol and self referral information in addition to brief motivational interview Receives: Behavioral: Brief Motivational Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital re-admissions
number of hospital re-admissions
Measured: 2 years
Secondary outcomes (3)
12 month AUDIT Results
Score on self administered questionnaire
Measured: 12 months
Moving violations/DUI
number of moving violations/DUI
Measured: 2 years
Self referral for counselling/treatment
number of self referrals for counseling/treatment
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2006 (estimated)
- Study startMar 2006
- Primary completion24 Jan 2027 (estimated)
- Study completion24 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Alcohol DrinkingStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 830 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- 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
- NCT00278785
- Sponsor's protocol ID
- 237217
- Other IDs
- Office of Traffic Safety, Grant Number AL0584
- Status last verified
- Feb 2026
- First submitted
- 13 Jan 2006
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Gentilello LM, Donovan DM, Dunn CW, Rivara FP. Alcohol interventions in trauma centers. Current practice and future directions. JAMA. 1995 Oct 4;274(13):1043-8.
PubMed 7563455Soderstrom CA, Smith GS, Dischinger PC, McDuff DR, Hebel JR, Gorelick DA, Kerns TJ, Ho SM, Read KM. Psychoactive substance use disorders among seriously injured trauma center patients. JAMA. 1997 Jun 11;277(22):1769-74.
PubMed 9178789Rivara FP, Koepsell TD, Jurkovich GJ, Gurney JG, Soderberg R. The effects of alcohol abuse on readmission for trauma. JAMA. 1993 Oct 27;270(16):1962-4.
PubMed 8105114Gentilello LM, Rivara FP, Donovan DM, Jurkovich GJ, Daranciang E, Dunn CW, Villaveces A, Copass M, Ries RR. Alcohol interventions in a trauma center as a means of reducing the risk of injury recurrence. Ann Surg. 1999 Oct;230(4):473-80; discussion 480-3. doi: 10.1097/00000658-199910000-00003.
PubMed 10522717Ockene JK, Adams A, Hurley TG, Wheeler EV, Hebert JR. Brief physician- and nurse practitioner-delivered counseling for high-risk drinkers: does it work? Arch Intern Med. 1999 Oct 11;159(18):2198-205. doi: 10.1001/archinte.159.18.2198.
PubMed 10527297Smith AJ, Hodgson RJ, Bridgeman K, Shepherd JP. A randomized controlled trial of a brief intervention after alcohol-related facial injury. Addiction. 2003 Jan;98(1):43-52. doi: 10.1046/j.1360-0443.2003.00251.x.
PubMed 12492754Spirito A, Monti PM, Barnett NP, Colby SM, Sindelar H, Rohsenow DJ, Lewander W, Myers M. A randomized clinical trial of a brief motivational intervention for alcohol-positive adolescents treated in an emergency department. J Pediatr. 2004 Sep;145(3):396-402. doi: 10.1016/j.jpeds.2004.04.057.
PubMed 15343198Monti PM, Colby SM, Barnett NP, Spirito A, Rohsenow DJ, Myers M, Woolard R, Lewander W. Brief intervention for harm reduction with alcohol-positive older adolescents in a hospital emergency department. J Consult Clin Psychol. 1999 Dec;67(6):989-94. doi: 10.1037//0022-006x.67.6.989.
PubMed 10596521Longabaugh R, Woolard RE, Nirenberg TD, Minugh AP, Becker B, Clifford PR, Carty K, Licsw, Sparadeo F, Gogineni A. Evaluating the effects of a brief motivational intervention for injured drinkers in the emergency department. J Stud Alcohol. 2001 Nov;62(6):806-16. doi: 10.15288/jsa.2001.62.806.
PubMed 11838918
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Intervention for Alcohol Use Among Injured Patients: A Prospective, Randomized Trial
- ClinicalTrials.gov ID
- NCT00278785
- Acronym / sponsor ID
- 237217
- Conditions
- Alcohol Drinking, Wounds and Injuries
- Keywords
- interviews, brief intervention, drinking, alcohol, injuries, wounds, intervention studies
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 830 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- California Office of Traffic Safety
- Study start
- Mar 2006
- Primary completion
- 24 Jan 2027 (estimated)
- Study completion
- 24 Jan 2027 (estimated)
- First posted
- 18 Jan 2006 (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 underlying hypothesis that providing brief interventions to individuals who engage in potentially harmful patterns of alcohol use will alter their drinking behavior and therefore avoid negative consequences. Specifically, this study aims to determine if brief interventions will:
- Reduce the number of re-admissions and deaths due to injuries associated with alcohol consumption
- Reduce the number of driving under the influence (DUI) arrests
- Reduce harmful drinking behavior
Detailed description
Alcohol use is the most common underlying cause of injuries in the United States. There is a growing body of literature suggesting that brief interventions (BI), in the form of a short (10-60 minute) counseling session, may decrease alcohol consumption and its harmful consequences. In contrast to the abundant literature on the effectiveness of BI in the outpatient setting, only 3 randomized controlled trials have been performed an adults specifically in the setting of acute trauma, and have had inconclusive results. All three studies used highly trained persons to perform the BI, and all were greater than 30 minutes in duration, a situation that may not necessarily reflect the practicalities of routine medical care. This raises the question of whether the benefits seen in these studies reflect the expertise of a small number of individuals or whether the effects correlate with the amount of time spent with the patient. Highly trained personnel and time are valuable commodities in a busy trauma center and may not be feasible given the competing clinical demands. We propose to investigate whether BI are effective in a setting that is more likely to reflect "real world" of clinical medicine rather than an idealized setting, utilizing trauma nurse practitioners to perform brief (5-10 minute) interviews.
We will identify all patients admitted with trauma who test positive on a blood alcohol test. These patients will be consented and randomized to either a brief intervention group, or a standard medical care group. All patients will receive an AUDIT questionnaire to identify patterns of drinking behavior and an alcohol information pamphlet. After discharge, patients will be telephoned at 1,6, and 12 months. The first 2 contacts will be to see how the patient is doing and to verify the contact information. The AUDIT questionnaire will be re-administered during the 12 month interview.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | –Control group to receive informational pamphlet on alcohol use and list of self referral agencies |
| 2 | Experimental | Behavioral: Brief Motivational InterviewIntervention group receives pamphlet on alcohol and self referral information in addition to brief motivational interview |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- >=18 yrs old
- English or Spanish Speaking
- Mentally and physically able to provide consent and participate in the intervention
- Admission to the trauma ward or ICU
Key exclusion criteria (4 listed)
- <18 yrs old
- Non-English or Non-Spanish Speaking
- Severe Psychiatric illness
- incarcerated
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 InterviewAlso: Brief intervention, Motivational interview10-20 minute brief motivational interview | Behavioural | 2 |
Primary outcome
Hospital re-admissions
Time frame: 2 years
number of hospital re-admissions
3 secondary outcomes
12 month AUDIT Results
Time frame: 12 months
Moving violations/DUI
Time frame: 2 years
Self referral for counselling/treatment
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Background: PubMed 7563455Gentilello LM, Donovan DM, Dunn CW, Rivara FP. Alcohol interventions in trauma centers. Current practice and future directions. JAMA. 1995 Oct 4;274(13):1043-8.
- Background: PubMed 9178789Soderstrom CA, Smith GS, Dischinger PC, McDuff DR, Hebel JR, Gorelick DA, Kerns TJ, Ho SM, Read KM. Psychoactive substance use disorders among seriously injured trauma center patients. JAMA. 1997 Jun 11;277(22):1769-74.
- Background: PubMed 8105114Rivara FP, Koepsell TD, Jurkovich GJ, Gurney JG, Soderberg R. The effects of alcohol abuse on readmission for trauma. JAMA. 1993 Oct 27;270(16):1962-4.
- Background: PubMed 10522717Gentilello LM, Rivara FP, Donovan DM, Jurkovich GJ, Daranciang E, Dunn CW, Villaveces A, Copass M, Ries RR. Alcohol interventions in a trauma center as a means of reducing the risk of injury recurrence. Ann Surg. 1999 Oct;230(4):473-80; discussion 480-3. doi: 10.1097/00000658-199910000-00003.
- Background: PubMed 10527297Ockene JK, Adams A, Hurley TG, Wheeler EV, Hebert JR. Brief physician- and nurse practitioner-delivered counseling for high-risk drinkers: does it work? Arch Intern Med. 1999 Oct 11;159(18):2198-205. doi: 10.1001/archinte.159.18.2198.
- Background: PubMed 12492754Smith AJ, Hodgson RJ, Bridgeman K, Shepherd JP. A randomized controlled trial of a brief intervention after alcohol-related facial injury. Addiction. 2003 Jan;98(1):43-52. doi: 10.1046/j.1360-0443.2003.00251.x.
- Background: PubMed 15343198Spirito A, Monti PM, Barnett NP, Colby SM, Sindelar H, Rohsenow DJ, Lewander W, Myers M. A randomized clinical trial of a brief motivational intervention for alcohol-positive adolescents treated in an emergency department. J Pediatr. 2004 Sep;145(3):396-402. doi: 10.1016/j.jpeds.2004.04.057.
- Background: PubMed 10596521Monti PM, Colby SM, Barnett NP, Spirito A, Rohsenow DJ, Myers M, Woolard R, Lewander W. Brief intervention for harm reduction with alcohol-positive older adolescents in a hospital emergency department. J Consult Clin Psychol. 1999 Dec;67(6):989-94. doi: 10.1037//0022-006x.67.6.989.
- Background: PubMed 11838918Longabaugh R, Woolard RE, Nirenberg TD, Minugh AP, Becker B, Clifford PR, Carty K, Licsw, Sparadeo F, Gogineni A. Evaluating the effects of a brief motivational intervention for injured drinkers in the emergency department. J Stud Alcohol. 2001 Nov;62(6):806-16. doi: 10.15288/jsa.2001.62.806.
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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 Alcohol Drinking and Wounds and Injuries, 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 4 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: under way, not looking for participants, as of the sponsor's last update on 10 Feb 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Hospital re-admissions (time frame: 2 years). 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 NCT00278785, which also lists 9 linked publications.
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 10 Feb 2026.