Alcoholism Clinical Trial
Official title:
Linkage of Alcohol Abusers to Primary Care
Verified date | October 2012 |
Source | Boston Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 569 |
Est. completion date | April 2012 |
Est. primary completion date | January 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Boston Medical Center / Boston University | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Boston Medical Center | National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Alcohol and drug use | 3, 6, and 12 months after baseline | No | |
Primary | Alcohol and drug-related problems | 3, 6, and 12 months after baseline | No | |
Primary | Nights Hospitalized | 3, 6, and 12 months after baseline and up to 2 years after the last subject is enrolled | No | |
Primary | Emergency department visits | 3, 6, and 12 months after baseline and up to 2 years after the last subject is enrolled | No | |
Secondary | Health-related quality of life | 3, 6, and 12 months after baseline | No | |
Secondary | Readiness to change | 3, 6, and 12 months after baseline | No | |
Secondary | Medical comorbidity | 3, 6, and 12 months after baseline | No | |
Secondary | Psychiatric comorbidity | 3, 6, and 12 months after baseline | No | |
Secondary | HIV risk behaviors | 3, 6, and 12 months after baseline | No | |
Secondary | Treatment utilization and costs | 3, 6, and 12 months after baseline, and up to 2 years after the last subject is enrolled | No |
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