ASAP Study - Hospital-Based Brief Intervention for Alcohol Problems

Alcohol Dependence Clinical Trial

Official title:

Hospital-based Brief Intervention for Alcohol Problems

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00183105
• Other study ID #: NIAAASaitz12617-ASAP
• Secondary ID: P60AA013759NIH A
• Status: Completed
• Phase: Phase 3
• First received: September 9, 2005
• Last updated: May 5, 2010
• Start date: February 2001
• Est. completion date: April 2006

Study information

• Verified date: December 2007
• Source: Boston Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

The objective of this project was to test whether screening and brief intervention for unhealthy alcohol use leads to improved alcohol-related outcomes (such as alcohol consumption and linkage to alcohol assistance) and is cost-effective.

Description:

In this study the effectiveness and cost-effectiveness of brief intervention for unhealthy alcohol use in a diverse group of hospitalized medical patients was tested.

We conducted a randomized trial of medical inpatients with the whole spectrum of alcohol problems from risky use through dependence. Subjects in one group received standard care; subjects in the second group received a brief motivational intervention tailored to the severity of his or her alcohol problem. Primary outcomes are alcohol consumption and linkage to alcohol treatment. Additional outcomes include health-related quality of life, health care utilization, alcohol problems, and readiness to change. Costs, and clinical outcomes measured in quality-adjusted life years, a standard metric that allows comparison to other chronic illnesses, will be compared in a cost-effectiveness analysis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years of age or older

• Fluent in English or Spanish

• Consume risky amounts of alcohol

• Provide 2 contacts to assist with follow-up

• Have no plans to move from the local area within a year of screening

• Score >21 on Mini-Mental State Examination (no serious cognitive impairment)

Study Design

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

Related Conditions & MeSH terms

• Alcohol Consumption
• Alcohol Dependence
• Alcohol Drinking
• Alcoholism

Intervention

Behavioral:
• Brief Intervention (adaptation of motivational interviewing)

Locations

Country	Name	City	State
United States	Boston Medical Center	Boston	Massachusetts

Sponsors (4)

Lead Sponsor	Collaborator
Boston Medical Center	Boston University, National Institute on Alcohol Abuse and Alcoholism (NIAAA), University of Pittsburgh

Country where clinical trial is conducted

United States, 

References & Publications (1)

Kraemer KL, Roberts MS, Horton NJ, Palfai T, Samet JH, Freedner N, Tibbetts N, Saitz R. Health utility ratings for a spectrum of alcohol-related health states. Med Care. 2005 Jun;43(6):541-50. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Linkage to alcohol assistance
Primary	Change in drinks per day
Secondary	Change in the number of times a subject exceeded per occasion limits
Secondary	Abstinence (dichotomous)
Secondary	Change in drinks per day
Secondary	Drinking risky amounts (dichotomous)
Secondary	Binge drinking (dichotomous)
Secondary	Hospitalization
Secondary	Emergency Department visits
Secondary	Health related quality of life
Secondary	Readiness to change alcohol use