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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ann Manzardo, PhD, University of Kansas
ClinicalTrials.gov Identifier:
NCT00680121
First received: May 15, 2008
Last updated: September 23, 2014
Last verified: September 2014

May 15, 2008
September 23, 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 ] [ Designated as safety issue: No ]
measured as standard drinks of alcohol per day (SD/day)
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
  • Alcoholism Severity Scale [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ 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: Control Group
    Placebo
    Intervention: Drug: Placebo
  • Experimental: Benfotiamine
    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
Not Provided
Principal Investigator: Ann Manzardo, PhD University of Kansas
University of Kansas
September 2014

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