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

This study has been completed.
Sponsor:
Collaborator:
Hanlon Trust
Information provided by (Responsible Party):
Ann Manzardo, PhD, University of Kansas
ClinicalTrials.gov Identifier:
NCT00680121
First received: May 15, 2008
Last updated: April 18, 2013
Last verified: April 2013
  Purpose

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
Alcoholism
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
Placebo
Drug: Placebo
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.

  Eligibility

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

Inclusion Criteria:

- Problem drinking in the last 30 days

Exclusion Criteria:

  • Prolonged abstinence
  • Serious medical problems
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00680121

Locations
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
University of Kansas
Hanlon Trust
Investigators
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:
Alcoholism
Benfotiamine
Thiamine

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

ClinicalTrials.gov processed this record on August 20, 2014