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

Primary Purpose

Alcoholism

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Benfotiamine
Placebo
Sponsored by
University of Kansas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcoholism focused on measuring Alcoholism, Benfotiamine, Thiamine

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Problem drinking in the last 30 days

Exclusion Criteria:

  • Prolonged abstinence
  • Serious medical problems

Sites / Locations

  • University of Kansas Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control Group

Benfotiamine

Arm Description

Placebo

Benfotiamine 600 mg

Outcomes

Primary Outcome Measures

Change in Average Daily Alcohol Consumption
measured as standard drinks of alcohol per day (SD/day)

Secondary Outcome Measures

Alcoholism Severity Scale
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
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
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.

Full Information

First Posted
May 15, 2008
Last Updated
September 23, 2014
Sponsor
University of Kansas
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1. Study Identification

Unique Protocol Identification Number
NCT00680121
Brief Title
High Dose Vitamin B1 to Reduce Abusive Alcohol Use
Acronym
B1AS
Official Title
The Effectiveness of Benfotiamine in Reducing Abusive Drinking Among Family History Positive and Negative Alcoholics
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Kansas

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholism
Keywords
Alcoholism, Benfotiamine, Thiamine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
Placebo
Arm Title
Benfotiamine
Arm Type
Experimental
Arm Description
Benfotiamine 600 mg
Intervention Type
Drug
Intervention Name(s)
Benfotiamine
Intervention Description
Benfotiamine 600 mg
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Change in Average Daily Alcohol Consumption
Description
measured as standard drinks of alcohol per day (SD/day)
Time Frame
Change from Baseline to 6 Months
Secondary Outcome Measure Information:
Title
Alcoholism Severity Scale
Description
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.
Time Frame
6 Months
Title
Barrett Impulsivity Scale: Total Impulsiveness
Description
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.
Time Frame
6 Months
Title
Symptom Checklist-90 (SCL-90): Global Severity Index
Description
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.
Time Frame
6 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Problem drinking in the last 30 days Exclusion Criteria: Prolonged abstinence Serious medical problems
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ann Manzardo, PhD
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25908323
Citation
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.
Results Reference
derived

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High Dose Vitamin B1 to Reduce Abusive Alcohol Use

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