Efficacy of Gabapentin in Alcohol Dependency Treatment

Chulalongkorn University

Status and phase: Completed; Phase 3

Conditions: Heavy Drinking; Alcohol Drinking

Treatments: Drug: Placebo oral capsule; Drug: Gabapentin 300mg

Study type: Interventional

Funder types: Other

Identifiers

NCT03274167

PMNIDAT#xx/2012

Details and patient eligibility

About

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.

Enrollment: 112 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

112 participants in 2 patient groups, including a placebo group

Gabapentin

Experimental group

Description:

300 mg per day once daily before bedtime

Treatment:

Drug: Gabapentin 300mg

Control

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo oral capsule