Alcohol AbusePhase 3NCT00280488
Enhanced Motivational Interviewing With Alcohol Positive Trauma Patients
A Phase 3 study testing Motivational Interview and Assessment in people with Alcohol Abuse and Alcohol Dependence, run by Brown University at 2 sites in United States.
Trial summary
The primary goal of this study is to test the efficacy of a brief intervention that includes the patient and a significant other, relative to an intervention including the patient only, for reducing alcohol use and alcohol-related problems among trauma patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Abuse, Alcohol Dependence
- What is being tested?
- Motivational Interview and Assessment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2005to Apr 2011
- Phase
- Phase 3
- 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
- admitted to trauma unit
- greater than 18 years old
- had a blood alcohol concentration (BAC) greater than .01% according to a biochemical test OR self-reported drinking alcohol in the 6 hours prior to the event that caused their hospital visit OR scored 8 or higher on the Alcohol Use Disorders Identification Test (AUDIT)
- identify at least one eligible significant other
Who cannot join
- not English-speaking
- had a self-inflicted injury
- in police custody
- did not pass a mental status exam
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Rhode Island Hospital
Providence, Rhode Island, 02903
Brown University
Providence, Rhode Island, 02912
About this study
Official title: Enhanced MI With Alcohol Positive Trauma Patients
The primary goal of this study is to test the efficacy of a brief intervention that includes the patient and a significant other, relative to an intervention including the patient only, for reducing alcohol use and alcohol-related problems among trauma patients.
Read the detailed description
Alcohol-positive trauma patients are more likely to be readmitted to a trauma center or subsequently die from an injury than are alcohol-negative patients. Empirically supported treatments to reduce alcohol use and alcohol-related problems (e.g., injuries, drinking and driving) in this high-risk population are needed, but few exist. This randomized controlled clinical trial assesses the efficacy of a brief intervention that includes the patient and a significant other, relative to an intervention including the patient only, for reducing alcohol use and alcohol-related problems among trauma patients.
Motivational Interviewing (MI), a brief, directive, non-confrontational intervention, has demonstrated some promise in this setting. Further, inclusion of a significant other (SO) in prolonged, intensive alcohol treatment appears to improve treatment retention and efficacy. Although inclusion of an SO in MI has been suggested, there are few data to support this endorsement.
Accordingly, this study will address whether motivational interviewing including both the trauma patient and an SO can more effectively decrease and maintain reductions in alcohol use and alcohol-related problems 6 and 12 months following discharge from the trauma unit than MI with the individual patient or an assessment-only condition.
The 2 MI groups will each receive 2 intervention sessions timed to occur in the hospital, and 1 booster session, occurring 1 month following discharge.
In the assessment-only condition, patients will receive only assessment of their drinking at baseline. This proposal will allow us to address the next phase of our program of research designed to develop easily disseminable treatments for these high-risk populations in medical settings. This study will also address potential mediators (motivation to change alcohol use, self-efficacy, alcohol treatment attendance, and social support for abstinence) and moderators of MI effects. The cost-effectiveness of the intervention will also be addressed.
Thus, this study will address both a significant public health problem and provide important information about MI mechanisms that may be relevant to the broader addiction treatment community.
- Conditions
- Alcohol Abuse, Alcohol Dependence
- Being tested
- Motivational Interview, Assessment
- Keywords
- Motivational Interviewing, Alcohol Abuse, Alcohol Dependence, Emergency Care Setting
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational InterviewBehavioural
Two intervention sessions timed to occur in the hospital, and 1 booster session, occurring 1 month following discharge.
AssessmentBehavioural
In the assessment-only condition, patients will receive only assessment of their drinking at baseline.
Motivational InterviewBehavioural
Two intervention sessions timed to occur in the hospital, and 1 booster session, occurring 1 month following discharge.
| Study group | Role | What they receive |
|---|---|---|
| 1) MI with SO | Active comparator | Motivational Interviewing (MI), a brief, directive, non-confrontational intervention, with inclusion of a significant other (SO) in prolonged, intensive alcohol treatment. Receives: Behavioral: Motivational Interview |
| 2) MI with patient only | Active comparator | Motivational Interviewing (MI), a brief, directive, non-confrontational intervention, with the individual patient Receives: Behavioral: Motivational Interview |
| 3) Assessment only | Active comparator | In the assessment-only condition, patients will receive only assessment of their drinking at baseline. Receives: Behavioral: Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol Consumption
Measured: 12 months
Alcohol-related problems (e.g., drinking and driving)
Measured: 12 months
Secondary outcomes (1)
Cost-effectiveness of intervention
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 posted23 Jan 2006 (estimated)
- Study startMay 2005
- Primary completionApr 2011 (estimated)
- Study completionApr 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol AbuseStudies of the same condition, open and under way.
- More trials run by Brown UniversityThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Investigators
- Peter Monti, PhD, Principal investigator, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00280488
- Sponsor's protocol ID
- NIAAAMON-009892-11A1
- Other IDs
- 3R01AA009892-15S1, NIH grant AA009892-11A1
- Status last verified
- Jun 2010
- First submitted
- 19 Jan 2006
- Last updated
- 25 Jun 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced MI With Alcohol Positive Trauma Patients
- ClinicalTrials.gov ID
- NCT00280488
- Acronym / sponsor ID
- NIAAAMON-009892-11A1
- Conditions
- Alcohol Abuse, Alcohol Dependence
- Keywords
- Motivational Interviewing, Alcohol Abuse, Alcohol Dependence, Emergency Care Setting
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- May 2005
- Primary completion
- Apr 2011 (estimated)
- Study completion
- Apr 2011 (estimated)
- First posted
- 23 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 primary goal of this study is to test the efficacy of a brief intervention that includes the patient and a significant other, relative to an intervention including the patient only, for reducing alcohol use and alcohol-related problems among trauma patients.
Detailed description
Alcohol-positive trauma patients are more likely to be readmitted to a trauma center or subsequently die from an injury than are alcohol-negative patients. Empirically supported treatments to reduce alcohol use and alcohol-related problems (e.g., injuries, drinking and driving) in this high-risk population are needed, but few exist. This randomized controlled clinical trial assesses the efficacy of a brief intervention that includes the patient and a significant other, relative to an intervention including the patient only, for reducing alcohol use and alcohol-related problems among trauma patients.
Motivational Interviewing (MI), a brief, directive, non-confrontational intervention, has demonstrated some promise in this setting. Further, inclusion of a significant other (SO) in prolonged, intensive alcohol treatment appears to improve treatment retention and efficacy. Although inclusion of an SO in MI has been suggested, there are few data to support this endorsement.
Accordingly, this study will address whether motivational interviewing including both the trauma patient and an SO can more effectively decrease and maintain reductions in alcohol use and alcohol-related problems 6 and 12 months following discharge from the trauma unit than MI with the individual patient or an assessment-only condition.
The 2 MI groups will each receive 2 intervention sessions timed to occur in the hospital, and 1 booster session, occurring 1 month following discharge.
In the assessment-only condition, patients will receive only assessment of their drinking at baseline. This proposal will allow us to address the next phase of our program of research designed to develop easily disseminable treatments for these high-risk populations in medical settings. This study will also address potential mediators (motivation to change alcohol use, self-efficacy, alcohol treatment attendance, and social support for abstinence) and moderators of MI effects. The cost-effectiveness of the intervention will also be addressed.
Thus, this study will address both a significant public health problem and provide important information about MI mechanisms that may be relevant to the broader addiction treatment community.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1) MI with SO | Active comparator | Behavioral: Motivational InterviewMotivational Interviewing (MI), a brief, directive, non-confrontational intervention, with inclusion of a significant other (SO) in prolonged, intensive alcohol treatment. |
| 2) MI with patient only | Active comparator | Behavioral: Motivational InterviewMotivational Interviewing (MI), a brief, directive, non-confrontational intervention, with the individual patient |
| 3) Assessment only | Active comparator | Behavioral: AssessmentIn the assessment-only condition, patients will receive only assessment of their drinking at baseline. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- admitted to trauma unit
- greater than 18 years old
- had a blood alcohol concentration (BAC) greater than .01% according to a biochemical test OR self-reported drinking alcohol in the 6 hours prior to the event that caused their hospital visit OR scored 8 or higher on the Alcohol Use Disorders Identification Test (AUDIT)
- identify at least one eligible significant other
Key exclusion criteria (4 listed)
- not English-speaking
- had a self-inflicted injury
- in police custody
- did not pass a mental status exam
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 |
|---|---|---|
| Motivational InterviewTwo intervention sessions timed to occur in the hospital, and 1 booster session, occurring 1 month following discharge. | Behavioural | 2) MI with patient only |
| AssessmentIn the assessment-only condition, patients will receive only assessment of their drinking at baseline. | Behavioural | 3) Assessment only |
| Motivational InterviewTwo intervention sessions timed to occur in the hospital, and 1 booster session, occurring 1 month following discharge. | Behavioural | 1) MI with SO |
Primary outcome
Alcohol Consumption
Time frame: 12 months
Alcohol-related problems (e.g., drinking and driving)
Time frame: 12 months
1 secondary outcome
Cost-effectiveness of intervention
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2010.
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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.
Peter Monti, PhD principal investigator
Brown University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Motivational Interview and Assessment in people with Alcohol Abuse and Alcohol Dependence, run by Brown University at 2 sites 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: status not confirmed, as of the sponsor's last update on 25 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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 Consumption (time frame: 12 months). The study lists 2 primary outcomes in all. 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 25 Jun 2010.