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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00252590
Other study ID # NEUA-003-05S
Secondary ID
Status Completed
Phase N/A
First received November 9, 2005
Last updated December 9, 2014
Start date November 2005
Est. completion date May 2009

Study information

Verified date December 2014
Source VA Office of Research and Development
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether a health focused motivational intervention will reduce alcohol use for dependent veterans who are receiving outpatient alcohol and drug treatment.


Description:

The early months of addiction treatment are a high risk time for relapse. The purpose of this study is to examine whether a health-related intervention delivered in an individual session with a therapist once per month in the initial 4 months of addiction treatment will reduce alcohol use among veterans already enrolled in weekly outpatient treatment group at the VA San Diego Healthcare System. In order to answer this question, study participants will be randomly assigned to one of three study conditions: 1) The Health Motivational condition that receives individual personalized health feedback and motivational activities, 2) the Health Education condition that receives individual education about health problems associated with the heavy alcohol use, and 3) the treatment as usual group that will receive no additional treatment. All participants will be assessed on a monthly basis for 4 months to evaluate alcohol use, drug use, and health status.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date May 2009
Est. primary completion date May 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 21 Years and older
Eligibility Inclusion Criteria:

- Veterans receiving outpatient treatment at the VA San Diego Healthcare System Alcohol and Drug Treatment Program for a diagnosis of Alcohol Dependence

Exclusion Criteria:

- Diagnosis of Bipolar Disorder or Psychotic Disorder.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Health Focused Motivational
Personalized feedback on health status
Health Education
Generalized health education related to alcohol use
Health Assessment only
Control group with no additional intervention

Locations

Country Name City State
United States VA San Diego Healthcare System, San Diego San Diego California

Sponsors (1)

Lead Sponsor Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Alcohol use over initial four months of treatment , assessed monthly 4 months No
Secondary Drug use and health status over initial four months of treatment, assessed monthly 4 months No
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