Enhanced Motivational Interviewing With Alcohol Positive Trauma Patients

Status Active, not recruiting

Clinical 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.

Clinical Trial 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00280488
Study type	Interventional
Source	Brown University
Contact
Status	Active, not recruiting
Phase	Phase 3
Start date	May 2005
Completion date	April 2011

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT02901041` - Interdisciplinary Study of A Novel Anticonvulsant in Alcoholism	Phase 3
Completed	`NCT03340051` - Remote Alcohol Monitoring and Episodic Thinking	N/A
Completed	`NCT02705898` - Lifestyle Physical Activity Intervention for Depressed Alcohol Dependent Women	N/A
Completed	`NCT02486900` - Neurofeedback & Alcohol Dependence	N/A
Completed	`NCT02179749` - Mifepristone Treatment of Alcohol Use Disorder	Phase 2
Completed	`NCT02197598` - Treatment of Patients Suffering of Alcohol Dependence and Impaired Liver Function With Selincro® As-needed Use	Phase 4
Recruiting	`NCT02385643` - The Efficacy of A Smartphone-based Support System to Reinforce Alcohol Abstinence in Treatment-seeking Patients	N/A
Completed	`NCT01828866` - Eye Movement Desensitization and Reprocessing (EMDR) in Alcohol Dependent Patients	N/A
Terminated	`NCT01408641` - Topiramate for Alcohol Use in Posttraumatic Stress Disorder	N/A
Active, not recruiting	`NCT01182766` - New Treatment for Alcohol and Nicotine Dependence	Phase 2/Phase 3
Completed	`NCT01342549` - Treatment Strategy for Alcohol Use Disorders in Veterans With TBI	Phase 3
Completed	`NCT02193204` - Chronic Alcohol, Stress Inflammatory Response and Relapse Risk	N/A
Completed	`NCT01176591` - HBPL Study of the Impact of the NK1 Antagonist Aprepitant	Phase 2
Completed	`NCT01165541` - A Study of Quetiapine and Mirtazapine for the Treatment of Alcohol Dependency	Phase 2
Completed	`NCT00585780` - Prazosin to Reduce Stress-Induced Alcohol/Drug Craving and Relapse	Phase 1/Phase 2
Completed	`NCT01056484` - Mindfulness Meditation for Health	Phase 2
Completed	`NCT00607620` - Disseminating Organizational SBI Services at Trauma Centers	N/A
Completed	`NCT00884884` - Aripiprazole and Topiramate on Free-Choice Alcohol Use	Phase 2/Phase 3
Completed	`NCT00463346` - Treatment With Acamprosate in Patients With Schizophrenia and Comorbid Alcoholism	Phase 3
Completed	`NCT00226694` - Alcohol and Gender Effects on Stress Circuit Function	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.