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Health Focused Motivational Treatment for Alcohol Dependent Veterans

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT00252590
First received: November 9, 2005
Last updated: February 19, 2016
Last verified: February 2016
Results First Received: June 25, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Alcoholism
Interventions: Behavioral: Health Motivational Feedback
Behavioral: Health Education
Behavioral: Control - treatment as usual

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Health Motivational Feedback

Personalized health-related feedback

Health Motivational Feedback: Personalized feedback on health status provided in four once monthly 45 minute sessions. Information for feedback was attained with assessments and blood serum testing.

Health Education

Non-personalized didactic health-related education

Health Education: Generalized health education related to alcohol use provided in four once monthly 45-minute sessions. Topics for sessions include sleep, pain, cardiovascular health, and gastrointestinal health.

Control - Treatment as Usual

No added treatment control

Control - treatment as usual: Control group with no additional intervention


Participant Flow:   Overall Study
    Health Motivational Feedback   Health Education   Control - Treatment as Usual
STARTED   35   30   34 
COMPLETED   33   28   31 
NOT COMPLETED   2   2   3 



  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.
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Reporting Groups
  Description
Health Motivational Feedback

Personalized health-related feedback

Health Motivational Feedback: Personalized feedback on health status

Health Education

Non-personalized didactic health-related education

Health Education: Generalized health education related to alcohol use

Control - Treatment as Usual

No added treatment control

Control - treatment as usual: Control group with no additional intervention

Total Total of all reporting groups

Baseline Measures
   Health Motivational Feedback   Health Education   Control - Treatment as Usual   Total 
Overall Participants Analyzed 
[Units: Participants]
 35   30   34   99 
Age 
[Units: Years]
Mean (Standard Deviation)
 48.1  (11.0)   49.4  (8.2)   49.1  (11.7)   48.8  (10.4) 
Gender 
[Units: Participants]
       
Female   4   3   2   9 
Male   31   27   32   90 
Region of Enrollment 
[Units: Participants]
       
United States   35   30   34   99 
Percentage Days Abstinent all substances 
[Units: Percentage]
Mean (Standard Deviation)
 48.6  (31.5)   59.6  (32.0)   47.4  (29.2)   51.5  (31.0) 
Percentage Days Abstinent alcohol 
[Units: Percentage]
Mean (Standard Deviation)
 49.1  (31.0)   60.1  (31.9)   48.2  (28.8)   52.1  (30.7) 


  Outcome Measures
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1.  Primary:   Percentage of Days Abstinent From Alcohol   [ Time Frame: 4 months ]

2.  Secondary:   Percentage of Days Abstinent From All Substances   [ Time Frame: 4 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
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  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: Dr. Susan Tate
Organization: VA San Diego Healthcare/University of California, San Diego
phone: 619-426-9402
e-mail: srtate@ucsd.edu



Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00252590     History of Changes
Other Study ID Numbers: NEUA-003-05S
Study First Received: November 9, 2005
Results First Received: June 25, 2015
Last Updated: February 19, 2016
Health Authority: United States: Federal Government