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Status unknownNCT00280488Updated Jun 25, 2010

Enhanced Motivational Interviewing With Alcohol Positive Trauma Patients

A Phase 3 interventional study of Motivational Interview and Assessment in Alcohol Abuse and Alcohol Dependence, sponsored by Brown University. Status unknown at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-06-25.

Sponsored by Brown University · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2010), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Alcohol Abuse
  • Alcohol Dependence

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Keywords

  • Motivational Interviewing
  • Alcohol Abuse
  • Alcohol Dependence
  • Emergency Care Setting
03

In context

Alcoholism

1,634 studies on the registry are indexed under Alcoholism; 329 are open to participants now.

This study's planned enrollment of 300 is above the median of 88 across 1,395 interventional studies indexed under Alcoholism.

Browse Alcoholism studies →

Lead sponsor

Brown University is the lead sponsor of 288 studies on the registry; 38 are open to participants now.

Of its 26 completed or terminated interventional studies of FDA-regulated products, 19 (73%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • not English-speaking
  • had a self-inflicted injury
  • in police custody
  • did not pass a mental status exam
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
300 participants (estimated)

Study arms

  • Active comparator
    1) MI with SO

    Motivational Interviewing (MI), a brief, directive, non-confrontational intervention, with inclusion of a significant other (SO) in prolonged, intensive alcohol treatment.

    Behavioral: Motivational Interview

  • Active comparator
    2) MI with patient only

    Motivational Interviewing (MI), a brief, directive, non-confrontational intervention, with the individual patient

    Behavioral: Motivational Interview

  • Active comparator
    3) Assessment only

    In the assessment-only condition, patients will receive only assessment of their drinking at baseline.

    Behavioral: Assessment

Interventions

  • BehavioralMotivational Interview

    Two intervention sessions timed to occur in the hospital, and 1 booster session, occurring 1 month following discharge.

  • BehavioralAssessment

    In the assessment-only condition, patients will receive only assessment of their drinking at baseline.

  • BehavioralMotivational Interview

    Two intervention sessions timed to occur in the hospital, and 1 booster session, occurring 1 month following discharge.

06

What researchers measure

Primary outcomes

  1. Alcohol Consumption

    Time frame: 12 months

  2. Alcohol-related problems (e.g., drinking and driving)

    Time frame: 12 months

Secondary outcomes

  1. Cost-effectiveness of intervention

    Time frame: 12 months

07

Study locations

2 sites
  • Rhode Island Hospital
    Providence, Rhode Island 02903, United States
  • Brown University
    Providence, Rhode Island 02912, United States
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of May 2005, a primary completion of Apr 2011 and a completion of Apr 2011. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 19, 2006
First posted
Jan 23, 2006
Start
May 2005
Primary completionEst.
Apr 2011
CompletionEst.
Apr 2011
Last update
Jun 25, 2010
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 25, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00280488
Lead sponsor
Brown University
First posted
Jan 23, 2006
Start date
May 2005
Primary completion
Apr 2011 (estimated)
Completion
Apr 2011 (estimated)
Last update
Jun 25, 2010

Study contacts

Peter Monti, PhD
principal investigator · Brown University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2010. You cannot join it, but the record below documents what was studied.

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