Addiction Health Evaluation And Disease Management (AHEAD) Study

Boston Medical Center (BMC)

Status and phase: Completed; Phase 3

Conditions: Drug Dependence; Alcoholism; Alcohol Dependence

Treatments: Behavioral: Standard care; Behavioral: Chronic Disease Management for substance abuse

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00278447

NIAAA Grant 2R01 AA010870-06A2

P60AA013759 (U.S. NIH Grant/Contract)

NIDA Grant 2R01 DA010019-07A1

SAI-010870-06A2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 569 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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569 participants in 2 patient groups

1) CDM

Active Comparator group

Description:

Chronic Disease Management

Treatment:

Behavioral: Chronic Disease Management for substance abuse

2) Standard care

Active Comparator group

Description:

Standard care

Treatment:

Behavioral: Standard care