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: April 24, 2015
Last verified: April 2015
Results First Received: October 1, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Alcohol Dependence
Interventions: Behavioral: Alcohol Care Management
Behavioral: Usual Care

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Arm 1

Care management for alcohol dependence

Alcohol Care Management: Care management for alcohol dependence with a focus on pharmacotherapy

Arm 2

Usual care

Alcohol Care Management: Care management for alcohol dependence with a focus on pharmacotherapy


Participant Flow:   Overall Study
    Arm 1     Arm 2  
STARTED     85     78  
COMPLETED     85     78  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Arm 1

Care management for alcohol dependence

Alcohol Care Management: Care management for alcohol dependence with a focus on pharmacotherapy

Arm 2

Usual care

Alcohol Care Management: Care management for alcohol dependence with a focus on pharmacotherapy

Total Total of all reporting groups

Baseline Measures
    Arm 1     Arm 2     Total  
Number of Participants  
[units: participants]
  85     78     163  
Age  
[units: years]
Mean (Standard Deviation)
  54.9  (11.4)     57.1  (10.1)     56  (10.8)  
Gender  
[units: participants]
     
Female     0     5     5  
Male     85     73     158  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     50     44     94  
White     35     34     69  
More than one race     0     0     0  
Unknown or Not Reported     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     85     78     163  
% Days of Heavy Drinking [1]
[units: % days of heavy drinking]
Mean (Standard Deviation)
  54.5  (53.8)     54.7  (33.6)     54.6  (44.1)  
The number of Subjects Engaged in Treatment at Baseline [2]
[units: Participants engaged in treatment]
  0     0     0  
[1] The measures the percent of days in the 60 days prior to randomization in which a participant drank more than 4 standard drinks (3 or more for women) in a given day.
[2] This was a measure of the proportion of patients engaged in addiction treatment at the time of randomization. It was a requirement that no of the subjects were engaged at baseline.



  Outcome Measures
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1.  Primary:   Treatment Engagement   [ Time Frame: 6 months ]

2.  Secondary:   Percent Days of Heavy Alcohol Use   [ Time Frame: 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The data presented in the results does not provide a true measure of the longitudinal effects done with GEE modeling.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: David Oslin
Organization: Philadelphia VA Medical Center
phone: 215 823 5894
e-mail: dave.oslin@va.gov


Publications of Results:

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00419315     History of Changes
Other Study ID Numbers: IIR 06-058
Study First Received: January 4, 2007
Results First Received: October 1, 2014
Last Updated: April 24, 2015
Health Authority: United States: Federal Government