High Dose Vitamin B1 to Reduce Abusive Alcohol Use

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Effectiveness of Benfotiamine in Reducing Abusive Drinking Among Family History Positive and Negative Alcoholics

Conditions
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Alcoholism

Intervention / Treatment
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* Drug: Benfotiamine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Problem drinking in the last 30 days Exclusion Criteria: Prolonged abstinence Serious medical problems

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control Group<br>Placebo | Drug: Placebo<br>* Placebo<br>|
| Experimental: Benfotiamine<br>Benfotiamine 600 mg | Drug: Benfotiamine<br>* Benfotiamine 600 mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Average Daily Alcohol Consumption | measured as standard drinks of alcohol per day (SD/day) | Change from Baseline to 6 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alcoholism Severity Scale | 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. | 6 Months | 
| Barrett Impulsivity Scale: Total Impulsiveness | 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. | 6 Months | 
| Symptom Checklist-90 (SCL-90): Global Severity Index | 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. | 6 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alcoholism, Benfotiamine, Thiamine