Alcoholism
Conditions
Keywords
Alcoholism, Benfotiamine, Thiamine
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.
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.
Interventions
DRUGBenfotiamine
Benfotiamine 600 mg
DRUGPlacebo
Placebo
Sponsors
University of Kansas
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Problem drinking in the last 30 days
Exclusion criteria
* Prolonged abstinence * Serious medical problems
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Average Daily Alcohol Consumption | Change from Baseline to 6 Months | measured as standard drinks of alcohol per day (SD/day) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Alcoholism Severity Scale | 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. |
| Barrett Impulsivity Scale: Total Impulsiveness | 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. |
| Symptom Checklist-90 (SCL-90): Global Severity Index | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Group Placebo; identically matched to Benfotiamine capsules | 60 |
| Benfotiamine Benfotiamine 600 mg; 4 capsules taken once daily by mouth for 24 weeks | 60 |
| Total | 120 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 27 | 23 |
Baseline characteristics
| Characteristic | Total | Benfotiamine | Control Group |
|---|---|---|---|
| Age 1st Drinking (years) | 16 years STANDARD_DEVIATION 4.3 | 15 years STANDARD_DEVIATION 3.2 | 16 years STANDARD_DEVIATION 5.2 |
| Age, Continuous | 47.5 years STANDARD_DEVIATION 7.9 | 48.1 years STANDARD_DEVIATION 6.9 | 46.9 years STANDARD_DEVIATION 8.7 |
| Alcoholism Severity | 17.2 scores on a scale STANDARD_DEVIATION 5.8 | 16.4 scores on a scale STANDARD_DEVIATION 5.3 | 17.9 scores on a scale STANDARD_DEVIATION 6.2 |
| Duration of Abuse (years) | 32 years STANDARD_DEVIATION 8.8 | 33 years STANDARD_DEVIATION 7.6 | 31 years STANDARD_DEVIATION 9.8 |
| Familial History (FH) of Alcoholism Negative for FH of alcoholism | 18 participants | 9 participants | 9 participants |
| Familial History (FH) of Alcoholism Positive for FH of alcoholism | 102 participants | 51 participants | 51 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 86 Participants | 43 Participants | 43 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) White | 28 Participants | 15 Participants | 13 Participants |
| Sex: Female, Male Female | 35 Participants | 17 Participants | 18 Participants |
| Sex: Female, Male Male | 85 Participants | 43 Participants | 42 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 60 | 0 / 60 |
| serious Total, serious adverse events | 0 / 60 | 0 / 60 |
Outcome results
Primary
Change in Average Daily Alcohol Consumption
measured as standard drinks of alcohol per day (SD/day)
Time frame: Change from Baseline to 6 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Change in Average Daily Alcohol Consumption | -3.4 alcoholic drinks per day | Standard Deviation 3.6 |
| Benfotiamine | Change in Average Daily Alcohol Consumption | -3.0 alcoholic drinks per day | Standard Deviation 4.6 |
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.
Time frame: 6 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Alcoholism Severity Scale | 14.0 scores on a scale | Standard Deviation 5.2 |
| Benfotiamine | Alcoholism Severity Scale | 10.7 scores on a scale | Standard Deviation 4.9 |
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.
Time frame: 6 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Barrett Impulsivity Scale: Total Impulsiveness | 65.0 scores on a scale | Standard Deviation 11.4 |
| Benfotiamine | Barrett Impulsivity Scale: Total Impulsiveness | 65.4 scores on a scale | Standard Deviation 9.4 |
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.
Time frame: 6 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Symptom Checklist-90 (SCL-90): Global Severity Index | 1.02 t-score | Standard Deviation 0.78 |
| Benfotiamine | Symptom Checklist-90 (SCL-90): Global Severity Index | 1.04 t-score | Standard Deviation 0.77 |