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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00680121
First Posted: May 19, 2008
Last Update Posted: September 25, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ann Manzardo, PhD, University of Kansas
May 15, 2008
May 19, 2008
April 28, 2014
September 25, 2014
September 25, 2014
July 2008
August 2011   (Final data collection date for primary outcome measure)
Change in Average Daily Alcohol Consumption [ Time Frame: Change from Baseline to 6 Months ]
measured as standard drinks of alcohol per day (SD/day)
Days of drinking [ Time Frame: 6 Months ]
Complete list of historical versions of study NCT00680121 on ClinicalTrials.gov Archive Site
  • Alcoholism Severity Scale [ Time Frame: 6 Months ]
    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.
  • Barrett Impulsivity Scale: Total Impulsiveness [ Time Frame: 6 Months ]
    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.
  • Symptom Checklist-90 (SCL-90): Global Severity Index [ Time Frame: 6 Months ]
    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.
Drinking severity scale, Beck depression scale, Barrett Impulsivity Scale, Breathalyzer Positive Tests [ Time Frame: 6 Months ]
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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Alcoholism
  • Drug: Benfotiamine
    Benfotiamine 600 mg
  • Drug: Placebo
    Placebo
  • Placebo Comparator: Control Group
    Placebo
    Intervention: Drug: Placebo
  • Experimental: Benfotiamine
    Benfotiamine 600 mg
    Intervention: Drug: Benfotiamine
Manzardo AM, Pendleton T, Poje A, Penick EC, Butler MG. Change in psychiatric symptomatology after benfotiamine treatment in males is related to lifetime alcoholism severity. Drug Alcohol Depend. 2015 Jul 1;152:257-63. doi: 10.1016/j.drugalcdep.2015.03.032. Epub 2015 Apr 8.

*   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
Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00680121
11236
No
Not Provided
Not Provided
Ann Manzardo, PhD, University of Kansas
University of Kansas
Not Provided
Principal Investigator: Ann Manzardo, PhD University of Kansas Medical Center
University of Kansas Medical Center
September 2014

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