ASAP Study - Hospital-Based Brief Intervention for Alcohol Problems - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

September 9, 2005

Last Updated Date

December 6, 2007

Start Date ^†

February 2001

Current Primary Outcome Measures ^†

Linkage to alcohol assistance
Change in drinks per day

Original Primary Outcome Measures ^†

Linkage to alcohol assistance
Change in drinks per day

Change History

Complete list of historical versions of study NCT00183105 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Change in the number of times a subject exceeded per occasion limits
Abstinence (dichotomous)
Change in drinks per day
Drinking risky amounts (dichotomous)
Binge drinking (dichotomous)
Hospitalization
Emergency Department visits
Health related quality of life
Readiness to change alcohol use

Original Secondary Outcome Measures ^†

Change in the number of times a subject exceeded per occasion limits
Abstinence (dichotomous)
Change in drinks per day
Drinking risky amounts (dichotomous)
Binge drinking (dichotomous)
Hospitalization
Emergency Department visits
Health related quality of life
Readiness to change alcohol use

Descriptive Information

Brief Title ^†

ASAP Study - Hospital-Based Brief Intervention for Alcohol Problems

Official Title ^†

Hospital-Based Brief Intervention for Alcohol Problems

Brief 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.

Detailed 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.

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Condition ^†

Alcohol Dependence
Alcohol Consumption

Intervention ^†

Behavioral: Brief Intervention (adaptation of motivational interviewing)

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

350

Completion Date

April 2006

Primary Completion Date

Eligibility Criteria ^†

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)

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00183105

Responsible Party

Secondary IDs ^††

NIH AA12617

Study Sponsor ^†

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborators ^††

University of Pittsburgh
Boston University

Investigators ^†

Principal Investigator:

Richard Saitz, M.D., M.P.H.

Boston Medical Center

Information Provided By

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Verification Date

December 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.