High Dose Vitamin B1 to Reduce Abusive Alcohol Use (B1AS)
B1AS tests the hypothesis that increased vitamin B1 (thiamine) intake can repair brain systems damaged by alcohol and help people with alcohol problems control their alcohol use. A strong, man-made form of thiamine (Benfotiamine) is used to increase blood thiamine to much higher levels than can be achieved using normal vitamin supplements. Drinking patterns are examined over 6 months of continued supplement use. Men and women with a recent history of alcohol problems are eligible to participate.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||The Effectiveness of Benfotiamine in Reducing Abusive Drinking Among Family History Positive and Negative Alcoholics|
- Change in Average Daily Alcohol Consumption [ Time Frame: Change from Baseline to 6 Months ] [ Designated as safety issue: No ]measured as standard drinks of alcohol per day (SD/day)
- Alcoholism Severity Scale [ Time Frame: 6 Months ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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.
|Study Start Date:||July 2008|
|Study Completion Date:||April 2013|
|Primary Completion Date:||August 2011 (Final data collection date for primary outcome measure)|
Placebo Comparator: Control Group
Other Name: Placebo
Benfotiamine 600 mg
Benfotiamine 600 mg
Other Name: Benfotiamine
B1AS is a randomized, double-blind placebo-controlled clinical trial of the effectiveness of Benfotiamine at reducing abusive drinking patterns in individuals with recent alcohol problems. Subjects consume 4 tablets of Benfotiamine (600 mg) or placebo daily for 6 months. Monthly follow-ups track alcohol use and alcohol-related problems over the 6 months. Blood tests are also conducted to determine the frequency of an inherited abnormality in thiamine processing that may be related to the risk of developing alcoholism.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00680121
|United States, Kansas|
|University of Kansas Medical Center|
|Kansas City, Kansas, United States, 66160|
|Principal Investigator:||Ann Manzardo, PhD||University of Kansas|