Addiction Health Evaluation And Disease Management (AHEAD) Study - Full Text View

Sponsored by:	National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by:	National Institute on Alcohol Abuse and Alcoholism (NIAAA)
ClinicalTrials.gov Identifier:	NCT00278447

Purpose

The objective of this study is to test whether a chronic disease management (CDM) program for substance abusers in primary care leads to improved alcohol and drug-related outcomes (such as reduced consumption and health problems) and health care utilization patterns.

Condition	Intervention	Phase
Alcohol Dependence Alcoholism Drug Dependence	Behavioral: Chronic Disease Management for substance abuse Behavioral: Standard care	Phase III

MedlinePlus related topics: Alcoholism Coping with Chronic Illness

Drug Information available for: Ethanol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Linkage of Alcohol Abusers to Primary Care

Further study details as provided by National Institute on Alcohol Abuse and Alcoholism (NIAAA):

Primary Outcome Measures:

Alcohol and drug use [ Time Frame: 3, 6, and 12 months after baseline ] [ Designated as safety issue: No ]
Alcohol and drug-related problems [ Time Frame: 3, 6, and 12 months after baseline ] [ Designated as safety issue: No ]
Nights Hospitalized [ Time Frame: 3, 6, and 12 months after baseline and up to 2 years after the last subject is enrolled ] [ Designated as safety issue: No ]
Emergency department visits [ Time Frame: 3, 6, and 12 months after baseline and up to 2 years after the last subject is enrolled ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Health-related quality of life [ Time Frame: 3, 6, and 12 months after baseline ] [ Designated as safety issue: No ]
Readiness to change [ Time Frame: 3, 6, and 12 months after baseline ] [ Designated as safety issue: No ]
Medical comorbidity [ Time Frame: 3, 6, and 12 months after baseline ] [ Designated as safety issue: No ]
Psychiatric comorbidity [ Time Frame: 3, 6, and 12 months after baseline ] [ Designated as safety issue: No ]
HIV risk behaviors [ Time Frame: 3, 6, and 12 months after baseline ] [ Designated as safety issue: No ]
Treatment utilization and costs [ Time Frame: 3, 6, and 12 months after baseline, and up to 2 years after the last subject is enrolled ] [ Designated as safety issue: No ]

Estimated Enrollment:	640
Study Start Date:	April 2006
Estimated Study Completion Date:	August 2009
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1) CDM: Active Comparator Chronic Disease Management	Behavioral: Chronic Disease Management for substance abuse Referral to primary medical care & longitudinal, multidisciplinary care for persons with substance dependence.
2) Standard care: Active Comparator Standard care	Behavioral: Standard care Referral to primary medical care for persons with substance dependence.

Detailed Description:

Chronic disease management (CDM) is a collaborative, longitudinal, proven effective approach to the treatment of chronic medical illnesses that addresses individual patient and health systems barriers to receipt of needed treatment. The objective of this Addiction Health Evaluation And Disease management (AHEAD) Study is to test the effectiveness of CDM for substance dependence in primary care. The study will enroll and randomize subjects to attend a substance dependence CDM program (the AHEAD Unit) integrated into a real-world primary care clinic or to referral to usual primary care. All subjects will be assessed regarding alcohol and/or drug diagnosis, consumption and problems, readiness to change, health-related quality of life, and medical and substance abuse treatment utilization. Primary outcomes are alcohol and drug use, alcohol and drug-related problems, emergency department visits, and hospitalizations. Additional outcomes are health-related quality of life, readiness to change, medical and psychiatric comorbidity, HIV risk behaviors, and treatment utilization and costs. The hypothesis is that compared with standard care, a health services intervention -- chronic disease management for alcohol and drug dependence integrated in primary care -- will decrease alcohol and drug use and related problems, and improve health care utilization patterns.

This study contains two studies (and study populations):

1. 320 alcohol dependent subjects with current risky drinking, and
2. 320 drug dependent subjects with current drug use.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

18 years of age or older
Fluent in English or Spanish
Alcohol or drug dependent
Heavy drinking in the past 30 days or recent drug use
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)

Exclusion Criteria:

Pregnant (self-report)
Breath alcohol >100 mg/dL
Inability to provide informed consent determined by trained research associates

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00278447

Locations

United States, Massachusetts
Boston Medical Center / Boston University
Boston, Massachusetts, United States, 02118

Sponsors and Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

Principal Investigator:

Richard Saitz, MD, MPH

Boston University

More Information

No publications provided

Responsible Party:	Boston Medical Center / Boston University ( Richard Saitz, MD, MPH )
Study ID Numbers:	SAI-010870-06A2, NIAAA Grant 2R01 AA010870-06A2, NIDA Grant 2R01 DA010019-07A1
Study First Received:	January 13, 2006
Last Updated:	November 14, 2008
ClinicalTrials.gov Identifier:	NCT00278447 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute on Alcohol Abuse and Alcoholism (NIAAA):

Alcohol
Alcohol use
Alcohol dependence
Drug
Drug use
Drug dependence

Utilization
Hospitalization
Primary care
Chronic disease management
Care management
Comorbidity

Study placed in the following topic categories:

Behavior, Addictive
Mental Disorders
Alcoholism
Substance-Related Disorders
Disorders of Environmental Origin

Alcohol-Related Disorders
Chronic Disease
Alcohol Drinking
Ethanol

Additional relevant MeSH terms:

Mental Disorders
Alcoholism
Substance-Related Disorders
Disorders of Environmental Origin
Alcohol-Related Disorders

ClinicalTrials.gov processed this record on May 07, 2009