High Dose Vitamin B1 to Reduce Abusive Alcohol Use (B1AS)
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Alcoholism |
Drug: Benfotiamine Drug: Placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | The Effectiveness of Benfotiamine in Reducing Abusive Drinking Among Family History Positive and Negative Alcoholics |
- Days of drinking [ Time Frame: 1 and 6 Months ] [ Designated as safety issue: No ]
- Drinking severity scale, Barrett Impulsivity Scale, Breathalyzer Positive Tests, SCL-90 [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
| Enrollment: | 120 |
| Study Start Date: | July 2008 |
| Study Completion Date: | April 2013 |
| Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: 1
Placebo
|
Drug: Placebo
Placebo
Other Name: Placebo
|
|
Experimental: 2
Benfotiamine 600 mg
|
Drug: Benfotiamine
Benfotiamine 600 mg
Other Name: Benfotiamine
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Problem drinking in the last 30 days
Exclusion Criteria:
- Prolonged abstinence
- Serious medical problems
Contacts and Locations| United States, Kansas | |
| University of Kansas Medical Center | |
| Kansas City, Kansas, United States, 66160 | |
| Principal Investigator: | Ann Manzardo, PhD | University of Kansas |
More Information
No publications provided
| Responsible Party: | Ann Manzardo, PhD, Assistant Professor, University of Kansas |
| ClinicalTrials.gov Identifier: | NCT00680121 History of Changes |
| Other Study ID Numbers: | 11236 |
| Study First Received: | May 15, 2008 |
| Last Updated: | April 18, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Kansas:
|
Alcoholism Benfotiamine Thiamine |
Additional relevant MeSH terms:
|
Alcoholism Alcohol-Related Disorders Substance-Related Disorders Mental Disorders Benphothiamine Thiamine Adjuvants, Immunologic Immunologic Factors |
Physiological Effects of Drugs Pharmacologic Actions Chelating Agents Molecular Mechanisms of Pharmacological Action Vitamin B Complex Vitamins Micronutrients Growth Substances |
ClinicalTrials.gov processed this record on May 19, 2013