Trial Outcomes & Findings for High Dose Vitamin B1 to Reduce Abusive Alcohol Use (NCT NCT00680121)

NCT ID: NCT00680121

Last Updated: 2014-09-25

Results Overview

measured as standard drinks of alcohol per day (SD/day)

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 120 participants
• Primary outcome timeframe: Change from Baseline to 6 Months
• Results posted on: 2014-09-25

Participant Flow

Participant milestones

Measure	Control Group Placebo; identically matched to Benfotiamine capsules	Benfotiamine Benfotiamine 600 mg; 4 capsules taken once daily by mouth for 24 weeks
Overall Study STARTED	60	60
Overall Study COMPLETED	33	37
Overall Study NOT COMPLETED	27	23

Reasons for withdrawal

Measure	Control Group Placebo; identically matched to Benfotiamine capsules	Benfotiamine Benfotiamine 600 mg; 4 capsules taken once daily by mouth for 24 weeks
Overall Study Lost to Follow-up	27	23

Baseline Characteristics

High Dose Vitamin B1 to Reduce Abusive Alcohol Use

Baseline characteristics by cohort

Measure	Control Group n=60 Participants Placebo; identically matched to Benfotiamine capsules	Benfotiamine n=60 Participants Benfotiamine 600 mg; 4 capsules taken once daily by mouth for 24 weeks	Total n=120 Participants Total of all reporting groups
Age, Continuous	46.9 years STANDARD_DEVIATION 8.7 • n=5 Participants	48.1 years STANDARD_DEVIATION 6.9 • n=7 Participants	47.5 years STANDARD_DEVIATION 7.9 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	17 Participants n=7 Participants	35 Participants n=5 Participants
Sex: Female, Male Male	42 Participants n=5 Participants	43 Participants n=7 Participants	85 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	43 Participants n=5 Participants	43 Participants n=7 Participants	86 Participants n=5 Participants
Race (NIH/OMB) White	13 Participants n=5 Participants	15 Participants n=7 Participants	28 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Familial History (FH) of Alcoholism Positive for FH of alcoholism	51 participants n=5 Participants	51 participants n=7 Participants	102 participants n=5 Participants
Familial History (FH) of Alcoholism Negative for FH of alcoholism	9 participants n=5 Participants	9 participants n=7 Participants	18 participants n=5 Participants
Alcoholism Severity	17.9 scores on a scale STANDARD_DEVIATION 6.2 • n=5 Participants	16.4 scores on a scale STANDARD_DEVIATION 5.3 • n=7 Participants	17.2 scores on a scale STANDARD_DEVIATION 5.8 • n=5 Participants
Duration of Abuse (years)	31 years STANDARD_DEVIATION 9.8 • n=5 Participants	33 years STANDARD_DEVIATION 7.6 • n=7 Participants	32 years STANDARD_DEVIATION 8.8 • n=5 Participants
Age 1st Drinking (years)	16 years STANDARD_DEVIATION 5.2 • n=5 Participants	15 years STANDARD_DEVIATION 3.2 • n=7 Participants	16 years STANDARD_DEVIATION 4.3 • n=5 Participants

PRIMARY outcome

Timeframe: Change from Baseline to 6 Months

measured as standard drinks of alcohol per day (SD/day)

Outcome measures

Measure	Control Group n=33 Participants Placebo; identically matched to Benfotiamine capsules	Benfotiamine n=37 Participants Benfotiamine 600 mg; 4 capsules taken once daily by mouth for 24 weeks
Change in Average Daily Alcohol Consumption	-3.4 alcoholic drinks per day Standard Deviation 3.6	-3.0 alcoholic drinks per day Standard Deviation 4.6

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Control Group n=33 Participants Placebo; identically matched to Benfotiamine capsules	Benfotiamine n=37 Participants Benfotiamine 600 mg; 4 capsules taken once daily by mouth for 24 weeks
Alcoholism Severity Scale	14.0 scores on a scale Standard Deviation 5.2	10.7 scores on a scale Standard Deviation 4.9

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Control Group n=33 Participants Placebo; identically matched to Benfotiamine capsules	Benfotiamine n=37 Participants Benfotiamine 600 mg; 4 capsules taken once daily by mouth for 24 weeks
Barrett Impulsivity Scale: Total Impulsiveness	65.0 scores on a scale Standard Deviation 11.4	65.4 scores on a scale Standard Deviation 9.4

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Control Group n=33 Participants Placebo; identically matched to Benfotiamine capsules	Benfotiamine n=37 Participants Benfotiamine 600 mg; 4 capsules taken once daily by mouth for 24 weeks
Symptom Checklist-90 (SCL-90): Global Severity Index	1.02 t-score Standard Deviation 0.78	1.04 t-score Standard Deviation 0.77

Adverse Events

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Benfotiamine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ann Manzardo, PhD

University of Kansas Medical Center

Phone: (913) 588-6473

Email: amanzardo@kumc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place