High Dose Vitamin B1 to Reduce Abusive Alcohol Use (B1AS)

Kansas Board of Regents

Status and phase: Completed; Phase 4

Conditions: Alcoholism

Treatments: Drug: Benfotiamine; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00680121

11236 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Problem drinking in the last 30 days

Exclusion criteria

• Prolonged abstinence
• Serious medical problems

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 2 patient groups, including a placebo group

Control Group

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo

Benfotiamine

Experimental group

Description:

Benfotiamine 600 mg

Treatment:

Drug: Benfotiamine