- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00680121
High Dose Vitamin B1 to Reduce Abusive Alcohol Use (B1AS)
September 23, 2014 updated by: Ann Manzardo, PhD, University of Kansas
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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
120
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Kansas
-
Kansas City, Kansas, United States, 66160
- University of Kansas Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Problem drinking in the last 30 days
Exclusion Criteria:
- Prolonged abstinence
- Serious medical problems
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Control Group
Placebo
|
Placebo
|
Experimental: Benfotiamine
Benfotiamine 600 mg
|
Benfotiamine 600 mg
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Average Daily Alcohol Consumption
Time Frame: Change from Baseline to 6 Months
|
measured as standard drinks of alcohol per day (SD/day)
|
Change from Baseline to 6 Months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
6 Months
|
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.
|
6 Months
|
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.
|
6 Months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ann Manzardo, PhD, University of Kansas Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2008
Primary Completion (Actual)
August 1, 2011
Study Completion (Actual)
April 1, 2013
Study Registration Dates
First Submitted
May 15, 2008
First Submitted That Met QC Criteria
May 16, 2008
First Posted (Estimate)
May 19, 2008
Study Record Updates
Last Update Posted (Estimate)
September 25, 2014
Last Update Submitted That Met QC Criteria
September 23, 2014
Last Verified
September 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11236 (DAIDS-ES)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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