Addiction Health Evaluation And Disease Management (AHEAD) Study

NCT ID: NCT00278447

Last Updated: 2014-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

569 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2012-04-30

Brief Summary

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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

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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.

Conditions

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Alcohol Dependence Alcoholism Drug Dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1) CDM

Chronic Disease Management

Group Type ACTIVE_COMPARATOR

Chronic Disease Management for substance abuse

Intervention Type BEHAVIORAL

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

2) Standard care

Standard care

Group Type ACTIVE_COMPARATOR

Standard care

Intervention Type BEHAVIORAL

Referral to primary medical care for persons with substance dependence.

Interventions

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Chronic Disease Management for substance abuse

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

Intervention Type BEHAVIORAL

Standard care

Referral to primary medical care for persons with substance dependence.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role collaborator

Boston Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Richard Saitz, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Boston University

Locations

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Boston Medical Center / Boston University

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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Park TW, Samet JH, Cheng DM, Winter MR, Kim TW, Fitzgerald A, Saitz R. The prescription of addiction medications after implementation of chronic care management for substance dependence in primary care. J Subst Abuse Treat. 2015 May;52:17-23. doi: 10.1016/j.jsat.2014.11.008. Epub 2014 Dec 2.

Reference Type DERIVED
PMID: 25524751 (View on PubMed)

Park TW, Cheng DM, Samet JH, Winter MR, Saitz R. Chronic care management for substance dependence in primary care among patients with co-occurring disorders. Psychiatr Serv. 2015 Jan 1;66(1):72-9. doi: 10.1176/appi.ps.201300414. Epub 2014 Nov 17.

Reference Type DERIVED
PMID: 25219686 (View on PubMed)

Saitz R, Cheng DM, Winter M, Kim TW, Meli SM, Allensworth-Davies D, Lloyd-Travaglini CA, Samet JH. Chronic care management for dependence on alcohol and other drugs: the AHEAD randomized trial. JAMA. 2013 Sep 18;310(11):1156-67. doi: 10.1001/jama.2013.277609.

Reference Type DERIVED
PMID: 24045740 (View on PubMed)

D'Amore MM, Cheng DM, Allensworth-Davies D, Samet JH, Saitz R. Disparities in safe sex counseling & behavior among individuals with substance dependence: a cross-sectional study. Reprod Health. 2012 Dec 31;9:35. doi: 10.1186/1742-4755-9-35.

Reference Type DERIVED
PMID: 23276300 (View on PubMed)

Other Identifiers

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P60AA013759

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NIAAA Grant 2R01 AA010870-06A2

Identifier Type: -

Identifier Source: secondary_id

NIDA Grant 2R01 DA010019-07A1

Identifier Type: -

Identifier Source: secondary_id

SAI-010870-06A2

Identifier Type: -

Identifier Source: org_study_id

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