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Addiction Health Evaluation And Disease Management (AHEAD) Study

Linkage of Alcohol Abusers to Primary Care

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00278447
Enrollment
569
Registered
2006-01-18
Start date
2006-04-30
Completion date
2012-04-30
Last updated
2014-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Dependence, Alcoholism, Drug Dependence

Keywords

Alcohol, Alcohol use, Alcohol dependence, Drug, Drug use, Drug dependence, Utilization, Hospitalization, Primary care, Chronic disease management, Care management, Comorbidity

Brief summary

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.

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.

Interventions

BEHAVIORALChronic Disease Management for substance abuse

Referral to primary medical care & longitudinal, multidisciplinary care for persons with substance dependence.

BEHAVIORALStandard care

Referral to primary medical care for persons with substance dependence.

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)
CollaboratorNIH
Boston Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Alcohol and drug use3, 6, and 12 months after baseline
Alcohol and drug-related problems3, 6, and 12 months after baseline
Nights Hospitalized3, 6, and 12 months after baseline and up to 2 years after the last subject is enrolled
Emergency department visits3, 6, and 12 months after baseline and up to 2 years after the last subject is enrolled

Secondary

MeasureTime frame
HIV risk behaviors3, 6, and 12 months after baseline
Health-related quality of life3, 6, and 12 months after baseline
Treatment utilization and costs3, 6, and 12 months after baseline, and up to 2 years after the last subject is enrolled
Readiness to change3, 6, and 12 months after baseline
Medical comorbidity3, 6, and 12 months after baseline
Psychiatric comorbidity3, 6, and 12 months after baseline

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 24, 2026