|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Department of Veterans Affairs |
|---|---|
| Information provided by: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00419315 |
Purpose
A randomized study of Alcohol Care Management for the treatment of alcohol dependence in primary care settings.
| Condition | Intervention | Phase |
|---|---|---|
|
Alcohol Dependence |
Behavioral: Alcohol Care Management |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Primary Care Based Disease Management for Alcohol Dependence |
| Estimated Enrollment: | 150 |
| Study Start Date: | August 2007 |
| Estimated Study Completion Date: | June 2011 |
| Estimated Primary Completion Date: | February 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Care management for alcohol dependence
|
Behavioral: Alcohol Care Management
Care management for alcohol dependence with a focus on pharmacotherapy
|
|
2: Sham Comparator
Usual care
|
Behavioral: Alcohol Care Management
Care management for alcohol dependence with a focus on pharmacotherapy
|
Background: Alcohol dependence is one of the leading causes of disability worldwide. Despite the availability of efficacious treatments less than 20% of individuals with alcohol dependence are actively engaged in treatment. Within the VA system systematic screening was implemented to increase the identification of patients with both abuse and dependence. However, there continues to be a marked discrepancy in the care offered or accessed among those identified with alcohol dependence. Existing treatment guidelines suggest that all persons with dependence receive care in specialty addiction treatment. Data from our center indicate that among those individuals screened in primary care who have AUDIT - C scores of >7, only 30% are formally evaluated with 50% receiving only brief advice and 20% having no evidence of assessment or referral. Of those assessed and referred to specialty care only 60% attend an initial visit and only 33% meet the EPRP performance measure of 2 visits per month for 90 days. This disparity in treatment access exists even though Veterans self report a desire to cut down and readiness to change drinking behaviors. (VA ACQUIP) and a willingness to consider pharmacotherapy.
Aims: Available evidence suggests that primary care may be a key component in the identification of alcohol dependent patients, delivery of initial interventions, and to the success of addiction treatment. Indeed, the vast majority of screening and new case identification occurs within primary care. The primary aims of this proposal are to test the effectiveness of a primary care based Alcohol Care Management (ACM) program and to evaluate the barriers and facilitators to accessing and engaging individuals into treatment. The ACM program uses a Behavioral Health Specialist to deliver care focused on the use of pharmacotherapy in combination with psychosocial support (Medication Management). This model may overcome barriers to care such as frequent intensive visit schedules often required in specialty settings, stigma associated with specialty care or group therapy approaches, access to specialty care in remote areas, and the current focus on a 12 step model of treatment. Secondary aims are to establish the acceptability of primary care based treatments and defining treatment modifiers such as age, barriers, co-occurring depression, and pharmacogenetic response.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Megan Aiello, BS | (215) 823-5800 ext 3404 | Megan.Aiello@va.gov |
| United States, New York | |
| VA Medical Center, Syracuse | Recruiting |
| Syracuse, New York, United States, 13210 | |
| Contact: Larry Lantinga, PhD 315-425-3487 larry.lantinga2@va.gov | |
| Contact: Steve Maisto, PhD samaisto@syr.edu | |
| Sub-Investigator: Steven Batki | |
| United States, Pennsylvania | |
| University of Pennsylvania | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: David W Oslin, MD 215-823-5870 oslin@mail.med.upenn.edu | |
| Contact: Megan Aiello, BS (215) 823-5800 ext 3404 Megan.Aiello@va.gov | |
| Principal Investigator: David W. Oslin, MD | |
| Principal Investigator: | David W. Oslin, MD | University of Pennsylvania |
More Information
| Responsible Party: | Department of Veterans Affairs ( Oslin, David - Principal Investigator ) |
| Study ID Numbers: | IIR 06-058 |
| Study First Received: | January 4, 2007 |
| Last Updated: | October 19, 2009 |
| ClinicalTrials.gov Identifier: | NCT00419315 History of Changes |
| Health Authority: | United States: Federal Government |
|
alcoholism primary care treatment |
|
Anti-Infective Agents Physiological Effects of Drugs Disorders of Environmental Origin Central Nervous System Depressants Pharmacologic Actions Anti-Infective Agents, Local Mental Disorders |
Therapeutic Uses Alcoholism Substance-Related Disorders Alcohol-Related Disorders Central Nervous System Agents Ethanol |