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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
History of Changes

May 15, 2008
April 18, 2013
July 2008
August 2011   (final data collection date for primary outcome measure)
Days of drinking [ Time Frame: 1 and 6 Months ] [ Designated as safety issue: No ]
Days of drinking [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00680121 on ClinicalTrials.gov Archive Site
Drinking severity scale, Barrett Impulsivity Scale, Breathalyzer Positive Tests, SCL-90 [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
Drinking severity scale, Beck depression scale, Barrett Impulsivity Scale, Breathalyzer Positive Tests [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
High Dose Vitamin B1 to Reduce Abusive Alcohol Use
The Effectiveness of Benfotiamine in Reducing Abusive Drinking Among Family History Positive and Negative Alcoholics

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.

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.
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Alcoholism
  • Drug: Benfotiamine
    Benfotiamine 600 mg
    Other Name: Benfotiamine
  • Drug: Placebo
    Placebo
    Other Name: Placebo
  • Placebo Comparator: 1
    Placebo
    Intervention: Drug: Placebo
  • Experimental: 2
    Benfotiamine 600 mg
    Intervention: Drug: Benfotiamine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
April 2013
August 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

- Problem drinking in the last 30 days

Exclusion Criteria:

  • Prolonged abstinence
  • Serious medical problems
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00680121
11236
No
Ann Manzardo, PhD, University of Kansas
University of Kansas
Hanlon Trust
Principal Investigator: Ann Manzardo, PhD University of Kansas
University of Kansas
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP