High Dose Vitamin B1 to Reduce Abusive Alcohol Use (B1AS)
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|ClinicalTrials.gov Identifier: NCT00680121|
Recruitment Status : Completed
First Posted : May 19, 2008
Results First Posted : September 25, 2014
Last Update Posted : September 25, 2014
|Condition or disease||Intervention/treatment||Phase|
|Alcoholism||Drug: Benfotiamine Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||The Effectiveness of Benfotiamine in Reducing Abusive Drinking Among Family History Positive and Negative Alcoholics|
|Study Start Date :||July 2008|
|Actual Primary Completion Date :||August 2011|
|Actual Study Completion Date :||April 2013|
Placebo Comparator: Control Group
Benfotiamine 600 mg
Benfotiamine 600 mg
- Change in Average Daily Alcohol Consumption [ Time Frame: Change from Baseline to 6 Months ]measured as standard drinks of alcohol per day (SD/day)
- Alcoholism Severity Scale [ Time Frame: 6 Months ]The alcoholism severity scale measures the severity of a person's dependence to alcohol. The scale ranges from a score of 0 (least severe) to 33 (most severe). The higher the score the worse the dependence.
- Barrett Impulsivity Scale: Total Impulsiveness [ Time Frame: 6 Months ]Scale measures impulsiveness. It includes 30 items that are scored to yield six first-order factors (attention, motor, self-control, cognitive complexity, perseverance, and cognitive instability impulsiveness) and three second-order factors (attentional, motor, and non-planning impulsiveness). Items are scored on a 4 point scale with 1 point equaling rarely/never up to 4 points equaling almost always/always. Total impulsivity score ranges from 30 (least impulsive) to 120 (most impulsive). The higher the score the higher the level of impulsiveness.
- Symptom Checklist-90 (SCL-90): Global Severity Index [ Time Frame: 6 Months ]The SCL-90 is a brief multidimensional self-report inventory that screens for nine symptoms of psychopathology and provides three global distress indicators. It provides an overview of symptom severity and intensity. The outcome measures psychiatric symptoms using a 30-item scale reported as t-scores relative to a normative population.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00680121
|United States, Kansas|
|University of Kansas Medical Center|
|Kansas City, Kansas, United States, 66160|
|Principal Investigator:||Ann Manzardo, PhD||University of Kansas Medical Center|