Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A Randomized Clinical Trial of Alcohol Care Management

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00419315
First received: January 4, 2007
Last updated: November 3, 2014
Last verified: November 2014

January 4, 2007
November 3, 2014
August 2007
March 2011   (final data collection date for primary outcome measure)
Treatment Engagement [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
This measured the percentage of subjects who attended at least 2 clinical addiction sessions in a given month. The outcome presented is the percentage during the 6th month of the trial.
Treatment Engagement
Complete list of historical versions of study NCT00419315 on ClinicalTrials.gov Archive Site
Percent Days of Heavy Alcohol Use [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
This is a measure during the 6 month of the percentage of 30 days in which a subject had at least 1 day of heavy drinking as defined by drinking more than 4 standard drinks in a day (3 or more for women).
Alcohol Use
Not Provided
Not Provided
 
A Randomized Clinical Trial of Alcohol Care Management
Primary Care Based Disease Management for Alcohol Dependence: A Randomized Clinical Trial

A randomized study of Alcohol Care Management for the treatment of alcohol dependence in primary care settings.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Alcohol Dependence
  • Behavioral: Alcohol Care Management
    Care management for alcohol dependence with a focus on pharmacotherapy
  • Behavioral: Usual Care
    Usual care included a referral to a specialty addiction treatment program.
  • Experimental: Alcohol Care Management
    Care management for alcohol dependence delivered in primary care
    Intervention: Behavioral: Alcohol Care Management
  • Active Comparator: Usual Care
    Usual care included a referral to specialty addiction treatment
    Intervention: Behavioral: Usual Care
Oslin DW, Lynch KG, Maisto SA, Lantinga LJ, McKay JR, Possemato K, Ingram E, Wierzbicki M. A randomized clinical trial of alcohol care management delivered in Department of Veterans Affairs primary care clinics versus specialty addiction treatment. J Gen Intern Med. 2014 Jan;29(1):162-8. doi: 10.1007/s11606-013-2625-8. Epub 2013 Sep 20.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
163
July 2011
March 2011   (final data collection date for primary outcome measure)

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 mania;
  • be relatively cognitively intact
  • not actively participate in specialized addition or behavioral health treatment within the prior 12 months
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00419315
IIR 06-058
Yes
Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Principal Investigator: David W. Oslin, MD Philadelphia VA Medical Center, Philadelphia, PA
Department of Veterans Affairs
November 2014

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