Trial | NCT03274167  Report issue

Title

Efficacy of Gabapentin in Alcohol Dependency Treatment
Efficacy of Gabapentin in Alcohol Dependency Treatment: a Double-blinded Randomized Placebo-controlled Trial

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    112
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.
Study Started
Jan 31
2012
Primary Completion
Dec 31
2014
Study Completion
Dec 31
2014
Last Update
Sep 06
2017

Drug Placebo oral capsule

Gabapentin Experimental

300 mg per day once daily before bedtime

Control Placebo Comparator

Capsule identical to the experimental arm, one tablet once daily before bedtime

Criteria 

Inclusion Criteria:

current diagnosis of alcohol dependence

Exclusion Criteria:

having major psychiatric disorders including schizophrenia, schizoaffective disorder, bipolar disorder, major depressive disorder, or suicide risk based on a clinical interview by attending psychiatrist
receiving other medications not in the protocol of the study for any reasons or having history of using other substances including methamphetamine, heroin, cannabis, inhalants, mitragyna speciosa (or kratom in Thai), except tobacco based on self-report
having a medical disease, e.g. essential hypertension, diabetes, renal (e.g., normal renal test) or liver disease (e.g., liver function test was not higher than two times of normal range and gamma-glutamyl transferase (GGT) is less than 800 U/L), epilepsy, stroke
having history of alcohol withdrawal seizure or delirium based on clinical interview by attending psychiatrist
having moderate to severe alcohol withdrawal symptoms based on score >13 of the Clinical Interview for Withdrawal Alcohol Arlington (CIWA - Ar) at the time of recruitment
having cognitive impairment based on score < 24 from the Mini Mental State Exam (MMSE)
having history of allergy to gabapentin
pregnancy or breast feeding.
No Results Posted