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Health Focused Motivational Treatment for Alcohol Dependent Veterans
This study has been completed.
Sponsor:
VA Office of Research and Development
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
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| Tracking Information | ||||
|---|---|---|---|---|
| First Received Date ICMJE | November 9, 2005 | |||
| Last Updated Date | February 19, 2016 | |||
| Start Date ICMJE | November 2005 | |||
| Primary Completion Date | May 2009 (Final data collection date for primary outcome measure) | |||
| Current Primary Outcome Measures ICMJE |
Percentage of Days Abstinent From Alcohol [ Time Frame: 4 months ] | |||
| Original Primary Outcome Measures ICMJE |
Alcohol use over initial four months of treatment , assessed monthly | |||
| Change History | Complete list of historical versions of study NCT00252590 on ClinicalTrials.gov Archive Site | |||
| Current Secondary Outcome Measures ICMJE |
Percentage of Days Abstinent From All Substances [ Time Frame: 4 months ] Percentage of days abstinent from both alcohol and drugs |
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| Original Secondary Outcome Measures ICMJE |
Drug use and health status over intial four months of treatment, assessed monthly | |||
| Current Other Outcome Measures ICMJE | Not Provided | |||
| Original Other Outcome Measures ICMJE | Not Provided | |||
| Descriptive Information | ||||
| Brief Title ICMJE | Health Focused Motivational Treatment for Alcohol Dependent Veterans | |||
| Official Title ICMJE | Health Focused Motivational Treatment for Alcohol Dependent Veterans | |||
| Brief 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. | |||
| Detailed 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. | |||
| Study Type ICMJE | Interventional | |||
| Study Phase | Not Provided | |||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Alcoholism | |||
| Intervention ICMJE |
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| Study Arms |
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| Publications * | Not Provided | |||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Enrollment ICMJE | 99 | |||
| Completion Date | May 2009 | |||
| Primary Completion Date | May 2009 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | 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:
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| Sex/Gender |
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| Ages | 21 Years and older (Adult, Senior) | |||
| Accepts Healthy Volunteers | Yes | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | United States | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00252590 | |||
| Other Study ID Numbers ICMJE | NEUA-003-05S | |||
| Has Data Monitoring Committee | Yes | |||
| U.S. FDA-regulated Product | Not Provided | |||
| Plan to Share Data | Not Provided | |||
| IPD Description | Not Provided | |||
| Responsible Party | VA Office of Research and Development | |||
| Study Sponsor ICMJE | VA Office of Research and Development | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
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| PRS Account | VA Office of Research and Development | |||
| Verification Date | February 2016 | |||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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