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High Dose Vitamin B1 to Reduce Abusive Alcohol Use (B1AS)

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ClinicalTrials.gov Identifier: NCT00680121
Recruitment Status : Completed
First Posted : May 19, 2008
Results First Posted : September 25, 2014
Last Update Posted : September 25, 2014
Information provided by (Responsible Party):
Ann Manzardo, PhD, University of Kansas

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Alcoholism
Interventions: Drug: Benfotiamine
Drug: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
Control Group Placebo; identically matched to Benfotiamine capsules
Benfotiamine Benfotiamine 600 mg; 4 capsules taken once daily by mouth for 24 weeks

Participant Flow:   Overall Study
    Control Group   Benfotiamine
STARTED   60   60 
COMPLETED   33   37 
NOT COMPLETED   27   23 
Lost to Follow-up                27                23 

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
Control Group Placebo; identically matched to Benfotiamine capsules
Benfotiamine Benfotiamine 600 mg; 4 capsules taken once daily by mouth for 24 weeks
Total Total of all reporting groups

Baseline Measures
   Control Group   Benfotiamine   Total 
Overall Participants Analyzed 
[Units: Participants]
 60   60   120 
[Units: Years]
Mean (Standard Deviation)
 46.9  (8.7)   48.1  (6.9)   47.5  (7.9) 
[Units: Participants]
Female   18   17   35 
Male   42   43   85 
Race (NIH/OMB) 
[Units: Participants]
American Indian or Alaska Native   0   0   0 
Asian   0   0   0 
Native Hawaiian or Other Pacific Islander   0   0   0 
Black or African American   43   43   86 
White   13   15   28 
More than one race   0   0   0 
Unknown or Not Reported   4   2   6 
Familial History (FH) of Alcoholism 
[Units: Participants]
Positive for FH of alcoholism   51   51   102 
Negative for FH of alcoholism   9   9   18 
Alcoholism Severity [1] 
[Units: Scores on a scale]
Mean (Standard Deviation)
 17.9  (6.2)   16.4  (5.3)   17.2  (5.8) 
[1] 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).
Duration of Abuse (years) 
[Units: Years]
Mean (Standard Deviation)
 31  (9.8)   33  (7.6)   32  (8.8) 
Age 1st Drinking (years) 
[Units: Years]
Mean (Standard Deviation)
 16  (5.2)   15  (3.2)   16  (4.3) 

  Outcome Measures

1.  Primary:   Change in Average Daily Alcohol Consumption   [ Time Frame: Change from Baseline to 6 Months ]

2.  Secondary:   Alcoholism Severity Scale   [ Time Frame: 6 Months ]

3.  Secondary:   Barrett Impulsivity Scale: Total Impulsiveness   [ Time Frame: 6 Months ]

4.  Secondary:   Symptom Checklist-90 (SCL-90): Global Severity Index   [ Time Frame: 6 Months ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact:  
Name/Title: Ann Manzardo, PhD
Organization: University of Kansas Medical Center
phone: (913) 588-6473
e-mail: amanzardo@kumc.edu

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Ann Manzardo, PhD, University of Kansas
ClinicalTrials.gov Identifier: NCT00680121     History of Changes
Other Study ID Numbers: 11236
First Submitted: May 15, 2008
First Posted: May 19, 2008
Results First Submitted: April 28, 2014
Results First Posted: September 25, 2014
Last Update Posted: September 25, 2014