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.
701 studies on the registry are indexed under Alcohol Drinking; 133 are open to participants now.
This study's enrollment of 112 is close to the median of 122 across 607 interventional studies indexed under Alcohol Drinking.
Browse Alcohol Drinking studies →Chulalongkorn University is the lead sponsor of 322 studies on the registry; 66 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
No publications or documents are linked to this record.
Ran from Jan 2012 to primary completion in Dec 2014, 35 months.
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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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Studies of the drug tested here: Gabapentin