High Dose Vitamin B1 to Reduce Abusive Alcohol Use
B1AS
The Effectiveness of Benfotiamine in Reducing Abusive Drinking Among Family History Positive and Negative Alcoholics
1 other identifier
interventional
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jul 2008
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 15, 2008
CompletedFirst Posted
Study publicly available on registry
May 19, 2008
CompletedStudy Start
First participant enrolled
July 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedResults Posted
Study results publicly available
September 25, 2014
CompletedSeptember 25, 2014
September 1, 2014
3.1 years
May 15, 2008
April 28, 2014
September 23, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Average Daily Alcohol Consumption
measured as standard drinks of alcohol per day (SD/day)
Change from Baseline to 6 Months
Secondary Outcomes (3)
Alcoholism Severity Scale
6 Months
Barrett Impulsivity Scale: Total Impulsiveness
6 Months
Symptom Checklist-90 (SCL-90): Global Severity Index
6 Months
Study Arms (2)
Control Group
PLACEBO COMPARATORPlacebo
Benfotiamine
EXPERIMENTALBenfotiamine 600 mg
Interventions
Eligibility Criteria
You may qualify if:
- Problem drinking in the last 30 days
You may not qualify if:
- Prolonged abstinence
- Serious medical problems
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Related Publications (1)
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.
PMID: 25908323DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Ann Manzardo, PhD
- Organization
- University of Kansas Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Ann Manzardo, PhD
University of Kansas Medical Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
May 15, 2008
First Posted
May 19, 2008
Study Start
July 1, 2008
Primary Completion
August 1, 2011
Study Completion
April 1, 2013
Last Updated
September 25, 2014
Results First Posted
September 25, 2014
Record last verified: 2014-09