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
  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:
  • 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)


Secondary Outcome Measures:
  • 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.


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: Control Group
Placebo
Drug: Placebo
Placebo
Other Name: Placebo
Experimental: Benfotiamine
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
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
Results First Received: April 28, 2014
Last Updated: September 23, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Kansas:
Alcoholism
Benfotiamine
Thiamine

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

ClinicalTrials.gov processed this record on October 30, 2014