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Addiction Health Evaluation And Disease Management (AHEAD) Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00278447
First Posted: January 18, 2006
Last Update Posted: October 2, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Boston Medical Center
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Linkage of Alcohol Abusers to Primary Care

Resource links provided by NLM:


Further study details as provided by Boston Medical Center:

Primary Outcome Measures:
  • Alcohol and drug use [ Time Frame: 3, 6, and 12 months after baseline ]
  • Alcohol and drug-related problems [ Time Frame: 3, 6, and 12 months after baseline ]
  • Nights Hospitalized [ Time Frame: 3, 6, and 12 months after baseline and up to 2 years after the last subject is enrolled ]
  • Emergency department visits [ Time Frame: 3, 6, and 12 months after baseline and up to 2 years after the last subject is enrolled ]

Secondary Outcome Measures:
  • Health-related quality of life [ Time Frame: 3, 6, and 12 months after baseline ]
  • Readiness to change [ Time Frame: 3, 6, and 12 months after baseline ]
  • Medical comorbidity [ Time Frame: 3, 6, and 12 months after baseline ]
  • Psychiatric comorbidity [ Time Frame: 3, 6, and 12 months after baseline ]
  • HIV risk behaviors [ Time Frame: 3, 6, and 12 months after baseline ]
  • Treatment utilization and costs [ Time Frame: 3, 6, and 12 months after baseline, and up to 2 years after the last subject is enrolled ]

Enrollment: 569
Study Start Date: April 2006
Study Completion Date: April 2012
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1) CDM
Chronic Disease Management
Behavioral: Chronic Disease Management for substance abuse
Referral to primary medical care & longitudinal, multidisciplinary care for persons with substance dependence.
Active Comparator: 2) Standard care
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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00278447


Locations
United States, Massachusetts
Boston Medical Center / Boston University
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston Medical Center
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
Principal Investigator: Richard Saitz, MD, MPH Boston University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Boston Medical Center
ClinicalTrials.gov Identifier: NCT00278447     History of Changes
Other Study ID Numbers: SAI-010870-06A2
P60AA013759 ( U.S. NIH Grant/Contract )
NIAAA Grant 2R01 AA010870-06A2
NIDA Grant 2R01 DA010019-07A1
First Submitted: January 13, 2006
First Posted: January 18, 2006
Last Update Posted: October 2, 2014
Last Verified: October 2012

Keywords provided by Boston Medical Center:
Alcohol
Alcohol use
Alcohol dependence
Drug
Drug use
Drug dependence
Utilization
Hospitalization
Primary care
Chronic disease management
Care management
Comorbidity

Additional relevant MeSH terms:
Alcoholism
Substance-Related Disorders
Alcohol-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs