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

This study has been completed.
Hanlon Trust
Information provided by (Responsible Party):
Ann Manzardo, PhD, University of Kansas
ClinicalTrials.gov Identifier:
First received: May 15, 2008
Last updated: April 18, 2013
Last verified: April 2013

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.

Condition Intervention Phase
Drug: Benfotiamine
Drug: Placebo
Phase 4

Study Type: Interventional
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

Resource links provided by NLM:

Further study details as provided by University of Kansas:

Primary Outcome Measures:
  • Days of drinking [ Time Frame: 1 and 6 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Drinking severity scale, Barrett Impulsivity Scale, Breathalyzer Positive Tests, SCL-90 [ Time Frame: 6 Months ] [ Designated as safety issue: No ]

Enrollment: 120
Study Start Date: July 2008
Study Completion Date: April 2013
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
Drug: Placebo
Other Name: Placebo
Experimental: 2
Benfotiamine 600 mg
Drug: Benfotiamine
Benfotiamine 600 mg
Other Name: Benfotiamine

Detailed 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.


Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

- Problem drinking in the last 30 days

Exclusion Criteria:

  • Prolonged abstinence
  • Serious medical problems
  Contacts and Locations
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
Sponsors and Collaborators
University of Kansas
Hanlon Trust
Principal Investigator: Ann Manzardo, PhD University of Kansas
  More Information

No publications provided

Responsible Party: Ann Manzardo, PhD, Assistant Professor, University of Kansas
ClinicalTrials.gov Identifier: NCT00680121     History of Changes
Other Study ID Numbers: 11236
Study First Received: May 15, 2008
Last Updated: April 18, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Kansas:

Additional relevant MeSH terms:
Alcohol-Related Disorders
Substance-Related Disorders
Mental Disorders
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Chelating Agents
Molecular Mechanisms of Pharmacological Action
Vitamin B Complex
Growth Substances

ClinicalTrials.gov processed this record on April 15, 2014