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

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.
 
ClinicalTrials.gov Identifier: NCT00680121
Recruitment Status : Completed
First Posted : May 19, 2008
Results First Posted : September 25, 2014
Last Update Posted : September 25, 2014
Sponsor:
Information provided by (Responsible Party):
Ann Manzardo, PhD, University of Kansas

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Alcoholism Drug: Benfotiamine Drug: Placebo Phase 4

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effectiveness of Benfotiamine in Reducing Abusive Drinking Among Family History Positive and Negative Alcoholics
Study Start Date : July 2008
Actual Primary Completion Date : August 2011
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Control Group
Placebo
 Drug: Placebo
Placebo
Experimental: Benfotiamine
Benfotiamine 600 mg
 Drug: Benfotiamine
Benfotiamine 600 mg


Outcome Measures
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Primary Outcome Measures :
  1. Change in Average Daily Alcohol Consumption [ Time Frame: Change from Baseline to 6 Months ]
    measured as standard drinks of alcohol per day (SD/day)


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Problem drinking in the last 30 days

Exclusion Criteria:

  • Prolonged abstinence
  • Serious medical problems
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00680121


Locations
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United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
University of Kansas
Investigators
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Principal Investigator: Ann Manzardo, PhD University of Kansas Medical Center
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Ann Manzardo, PhD, Assistant Professor, University of Kansas
ClinicalTrials.gov Identifier: NCT00680121    
Other Study ID Numbers: 11236
First Posted: May 19, 2008    Key Record Dates
Results First Posted: September 25, 2014
Last Update Posted: September 25, 2014
Last Verified: September 2014
Keywords provided by Ann Manzardo, PhD, University of Kansas:
Alcoholism
Benfotiamine
Thiamine
Additional relevant MeSH terms:
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Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Benphothiamine
 Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action