Alcohol is one of most common harmful substance, and alcohol intake brings great burden on health worldwide. Excess alcohol intake may lead to alcohol-related brain injuries and cognitive impairment. Although both nerve growth factor and antioxidative treatment were effective to relieve alcohol-related injuries in central nervous system in the preclinical studies, there is no relevant clinical trial about their efficacy and safety on patients. Since nerve growth factor and one of the antioxidative medication, edaravone, have been used in some neural diseases in clinical trials, we tend to evaluate the efficacy and safety of nerve growth factor, or edaravone on alcohol-induced brain injuries. The study is a randomized-controlled study and the patients will be assigned into one of the following three groups randomly: (1) regular treatment (combination of vitamin B1, B6, C, E and mecobalamine) with nerve growth factor for 2 weeks and subsequently regular treatment for 6 months; (2) regular treatment (RT) with edaravone for 2 weeks and subsequently RT for 6 months; (3) RT alone for 6 months. The patients will be followed up for 6 months. Cognitive functions, recurrence of alcohol dependence, duration of abstention, alcohol intake, craving for alcohol and other psychological assessments will be recorded and compared among the 3 treatment groups and the efficacy of nerve growth factor or edaravone will be evaluated in our study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
150
Intramuscular injection for 2 weeks
Intravenous injection for 2 weeks
Medications of combination of vitamin B1, B6, C, E and mecobalamine for 6 months
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGCognitive improvement
Executive function by digit symbol substitute test (DSST) ranging from 0 to 90. Higher score indicates better executive function.
Time frame: 2 weeks
Cognitive improvement
Executive function by digit symbol substitute test (DSST) ranging from 0 to 90. Higher score indicates better executive function.
Time frame: 2 months
Cognitive improvement
Executive function by digit symbol substitute test (DSST) ranging from 0 to 90. Higher score indicates better executive function.
Time frame: 3 months
Cognitive improvement
Executive function by digit symbol substitute test (DSST) ranging from 0 to 90. Higher score indicates better executive function.
Time frame: 6 months
Cognitive assessment
Cognitive assessment by Montreal Cognitive Assessment (MoCA) ranging from 0 to 30. Lower score indicates worse cognitive function.
Time frame: 3 months
Cognitive assessment
Cognitive assessment by Montreal Cognitive Assessment (MoCA) ranging from 0 to 30. Lower score indicates worse cognitive function.
Time frame: 6 months
The rate of relapse of alcohol dependence after discharge from hospital
Recurrence of alcohol dependence
Time frame: 2 months
Duration of abstinence
The total time or period without any intake of alcohol during follow ups
Time frame: 6 months
Alcohol intake
Diaries of alcohol intake in different time of the follow ups
Time frame: 2 weeks, 2 months, 3 months, 6 months
Craving for alcohol
Craving assessment for alcohol by Obsessive Compulsive Drinking Scale (OCDS) ranging from 0 to 40. Higher score of OCDS indicates more desire for alcohol.
Time frame: 2 weeks, 2 months, 3 months, 6 months
Psychological assessment - Anxiety
Psychological assessment by Generalized Anxiety Disorder-7 (GAD-7) ranging from 0 to 21. Higher score indicates more severer anxiety.
Time frame: 2 weeks, 2 months, 3 months, 6 months
Psychological assessment - Depression
Psychological assessment by Patient Health Questionnaire-9 (PHQ-9) ranging from 0 to 27. Higher score indicates more severer depression.
Time frame: 2 weeks, 2 months, 3 months, 6 months
Psychological assessment - Sleep
Psychological assessment by Pittsburgh Sleep Quality Index (PSQI) ranging from 0 to 21. Higher score indicates worse sleep.
Time frame: 2 weeks, 2 months, 3 months, 6 months
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