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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Placebo Comparator | Placebo |
|
| Benfotiamine | Experimental | Benfotiamine 600 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Benfotiamine | Drug | Benfotiamine 600 mg |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Average Daily Alcohol Consumption | measured as standard drinks of alcohol per day (SD/day) | Change from Baseline to 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 Months |
| Barrett Impulsivity Scale: Total Impulsiveness |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ann Manzardo, PhD | University of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25908323 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Group | Placebo; identically matched to Benfotiamine capsules |
| FG001 | Benfotiamine | Benfotiamine 600 mg; 4 capsules taken once daily by mouth for 24 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Group | Placebo; identically matched to Benfotiamine capsules |
| BG001 | Benfotiamine | Benfotiamine 600 mg; 4 capsules taken once daily by mouth for 24 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Average Daily Alcohol Consumption | measured as standard drinks of alcohol per day (SD/day) | Mean | Standard Deviation | alcoholic drinks per day | Change from Baseline to 6 Months |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control Group | Placebo; identically matched to Benfotiamine capsules |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ann Manzardo, PhD | University of Kansas Medical Center | (913) 588-6473 | amanzardo@kumc.edu |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C013835 | benphothiamine |
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| Drug |
Placebo |
|
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 | 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Familial History (FH) of Alcoholism | Number | participants |
|
| Alcoholism Severity | The alcoholism severity scale measures the severity of a person's dependence to alcohol. The severity is measured from 0 (least severe) to 33 (most severe). | Mean | Standard Deviation | scores on a scale |
|
| Duration of Abuse (years) | Mean | Standard Deviation | years |
|
| Age 1st Drinking (years) | Mean | Standard Deviation | years |
|
| Participants |
|
|
| Secondary | 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. | Mean | Standard Deviation | scores on a scale | 6 Months |
|
|
|
| Secondary | 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. | Mean | Standard Deviation | scores on a scale | 6 Months |
|
|
|
| Secondary | 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. | Mean | Standard Deviation | t-score | 6 Months |
|
|
|
| 0 |
| 60 |
| 0 |
| 60 |
| EG001 | Benfotiamine | Benfotiamine 600 mg; 4 capsules taken once daily by mouth for 24 weeks | 0 | 60 | 0 | 60 |
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