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Alcohol Care Management
This study is currently recruiting participants.
Verified by Department of Veterans Affairs, October 2009
First Received: January 4, 2007   Last Updated: October 19, 2009   History of Changes
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

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Treatment Engagement [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Alcohol Use [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

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

Detailed Description:

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
Criteria

Inclusion Criteria:

  • be men and women = 18 years of age;
  • meet criteria for alcohol dependence;
  • drink more than an average of 2 drinks per day prior to study entry (over the last 60 days);
  • have adequate hearing to participate in assessment

Exclusion Criteria:

  • show no evidence of current abuse or dependence of illicit substances other than marijuana;
  • no current hallucinations;
  • no current symptoms of PTSD;
  • or current symptoms of mania;
  • be relatively cognitively intact
  • not actively participate in specialized addition or behavioral health treatment within the prior 12 months
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00419315

Contacts
Contact: Megan Aiello, BS (215) 823-5800 ext 3404 Megan.Aiello@va.gov

Locations
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            
Sponsors and Collaborators
Investigators
Principal Investigator: David W. Oslin, MD University of Pennsylvania
  More Information

No publications provided

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

Keywords provided by Department of Veterans Affairs:
alcoholism
primary care
treatment

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on November 20, 2009