Phase 4
N=120
High Dose Vitamin B1 to Reduce Abusive Alcohol Use
Alcoholism
Bottom Line
View on ClinicalTrials.gov: NCT00680121 ↗Enrolled (actual)
120
Serious AEs
0.0%
Results posted
Sep 2014
Primary outcome: Primary: Change in Average Daily Alcohol Consumption — -3.4; -3.0 alcoholic drinks per day
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Benfotiamine (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Kansas
- Primary completion
- Aug 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Average Daily Alcohol Consumption |
-3.4; -3.0 | — |
| SECONDARY Alcoholism Severity Scale |
14.0; 10.7 | — |
| SECONDARY Barrett Impulsivity Scale: Total Impulsiveness |
65.0; 65.4 | — |
| SECONDARY Symptom Checklist-90 (SCL-90): Global Severity Index |
1.02; 1.04 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Problem drinking in the last 30 days
Exclusion Criteria
- Prolonged abstinence
- Serious medical problems
Data sourced from ClinicalTrials.gov (NCT00680121). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.