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Completed

NCT Number: NCT00278447

Addiction Health Evaluation And Disease Management (AHEAD) Study

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Boston Medical Center / Boston University

Boston, Massachusetts, 02118, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chronic Disease Management for substance abuse

Behavioral

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

Standard Care

Behavioral

Referral to primary medical care for persons with substance dependence.

Primary outcomes

  1. Alcohol and drug use

    Time frame: 3, 6, and 12 months after baseline

  2. Alcohol and drug-related problems

    Time frame: 3, 6, and 12 months after baseline

  3. Nights Hospitalized

    Time frame: 3, 6, and 12 months after baseline and up to 2 years after the last subject is enrolled

  4. Emergency department visits

    Time frame: 3, 6, and 12 months after baseline and up to 2 years after the last subject is enrolled

Secondary outcomes

  1. Health-related quality of life

    Time frame: 3, 6, and 12 months after baseline

  2. Readiness to change

    Time frame: 3, 6, and 12 months after baseline

  3. Medical comorbidity

    Time frame: 3, 6, and 12 months after baseline

  4. Psychiatric comorbidity

    Time frame: 3, 6, and 12 months after baseline

  5. HIV risk behaviors

    Time frame: 3, 6, and 12 months after baseline

  6. Treatment utilization and costs

    Time frame: 3, 6, and 12 months after baseline, and up to 2 years after the last subject is enrolled

Sponsors and collaborators

Lead sponsor

Boston Medical Center

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Official study title

Linkage of Alcohol Abusers to Primary Care

Important dates

Study start
2006
Primary completion
2010
Study completion
2012
First posted
Jan 18, 2006
Registry last updated
Oct 2, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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