A Phase 3 interventional study of Gabapentin 300mg and Placebo oral capsule in Alcohol Drinking and Heavy Drinking, sponsored by Chulalongkorn University. Completed at 1 site in Thailand. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-09-06.
Sponsored by Chulalongkorn University · Phase 3, Interventional, and Treatment
The study aims to study the effect of gabapentin on the number of alcohol drinking days and heavy drinking days in the Thai clinical alcohol-dependent population by using the double-blinded randomized controlled approach. One-hundred and twelve individuals with alcohol dependence were randomly assigned equally into two groups including treatment with gabapentin and placebo. Thirty-four patients (30.3%) completed the study protocol, i.e. treatment with gabapentin at least 300 mg per day or placebo orally once a day for twelve weeks. Pattern of alcohol drinking were obtained from the timelime followback. Drinking behaviors were compared between the two groups by poisson repeated measures model.
Exclusion Criteria:
300 mg per day once daily before bedtime
Drug: Gabapentin 300mg
Capsule identical to the experimental arm, one tablet once daily before bedtime
Drug: Placebo oral capsule
Frequency of heavy drinking
Days per week of alcohol heavy drinking as measured by timelime followback (TLFB) (Sobell et al., 2001) - adapted Thai version. TLFB is the self-report form for a respondent to note days of heavy alcohol drinking, daily amount, and any symptoms related to alcohol drinking including days per week of alcohol drinking. The TLFB was given to the subjects after explaining how to record daily drinking behaviors and symptoms at home.
Time frame: weekly for 12 weeks
Frequency of drinking
Days per week of alcohol drinking as measured by timelime followback (TLFB) (Sobell et al., 2001) - adapted Thai version. TLFB is the self-report form for a respondent to note days of heavy alcohol drinking, daily amount, and any symptoms related to alcohol drinking including days per week of alcohol drinking. The TLFB was given to the subjects after explaining how to record daily drinking behaviors and symptoms at home.
Time frame: weekly for 12 weeks
Plan to share: Undecided
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This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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Chulalongkorn University