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Addiction Health Evaluation And Disease Management (AHEAD) Study

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Boston Medical Center
ClinicalTrials.gov Identifier:
NCT00278447
First received: January 13, 2006
Last updated: October 1, 2014
Last verified: October 2012

January 13, 2006
October 1, 2014
April 2006
January 2010   (final data collection date for primary outcome measure)
  • 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 ]
  • Alcohol and drug use
  • Alcohol and drug-related problems
  • Emergency department visits
  • Hospitalizations
Complete list of historical versions of study NCT00278447 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Health-related quality of life
  • Readiness to change
  • Medical comorbidity
  • Psychiatric comorbidity
  • HIV risk behaviors
  • Treatment utilization and costs
Not Provided
Not Provided
 
Addiction Health Evaluation And Disease Management (AHEAD) Study
Linkage of Alcohol Abusers to Primary Care

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.

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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Alcohol Dependence
  • Alcoholism
  • Drug Dependence
  • Behavioral: Chronic Disease Management for substance abuse
    Referral to primary medical care & longitudinal, multidisciplinary care for persons with substance dependence.
  • Behavioral: Standard care
    Referral to primary medical care for persons with substance dependence.
  • Active Comparator: 1) CDM
    Chronic Disease Management
    Intervention: Behavioral: Chronic Disease Management for substance abuse
  • Active Comparator: 2) Standard care
    Standard care
    Intervention: Behavioral: Standard care

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
569
April 2012
January 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00278447
SAI-010870-06A2, P60AA013759, NIAAA Grant 2R01 AA010870-06A2, NIDA Grant 2R01 DA010019-07A1
No
Boston Medical Center
Boston Medical Center
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Principal Investigator: Richard Saitz, MD, MPH Boston University
Boston Medical Center
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP