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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ann Manzardo, PhD, University of Kansas
ClinicalTrials.gov Identifier:
NCT00680121
First received: May 15, 2008
Last updated: September 23, 2014
Last verified: September 2014
Results First Received: April 28, 2014  
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
Condition: Alcoholism
Interventions: Drug: Benfotiamine
Drug: Placebo

  Participant Flow
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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
  Description
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
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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
  Description
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  
Number of Participants  
[units: participants]
  60     60     120  
Age  
[units: years]
Mean ± Standard Deviation
  46.9  ± 8.7     48.1  ± 6.9     47.5  ± 7.9  
Gender  
[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  
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  
[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).



  Outcome Measures
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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
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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
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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


No publications provided


Responsible Party: Ann Manzardo, PhD, University of Kansas
ClinicalTrials.gov Identifier: NCT00680121     History of Changes
Other Study ID Numbers: 11236
Study First Received: May 15, 2008
Results First Received: April 28, 2014
Last Updated: September 23, 2014
Health Authority: United States: Institutional Review Board