Efficacy of Gabapentin in Alcohol Dependency Treatment

NCT ID: NCT03274167

Last Updated: 2017-09-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2014-12-31

Brief Summary

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.

Conditions

Alcohol Drinking; Heavy Drinking

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT

Study Groups

Gabapentin

300 mg per day once daily before bedtime

Group Type: EXPERIMENTAL

Gabapentin 300mg

Intervention Type: DRUG

Control

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

Group Type: PLACEBO_COMPARATOR

Placebo oral capsule

Intervention Type: DRUG

Interventions

Gabapentin 300mg

Intervention Type: DRUG

Placebo oral capsule

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Princess Mother National Institute on Drug Abuse and Treatment

UNKNOWN

Sponsor Role: collaborator

Chulalongkorn University

OTHER

Sponsor Role: lead

Responsible Party

Rasmon Kalayasiri

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sumnao Nilaban

Role: PRINCIPAL_INVESTIGATOR

Princess Mother National Institute on Drug Abuse and Treatment

Locations

Princess Mother National Institute on Drug Abuse and Treatment

Pathum Thani, , Thailand

Countries

Thailand

Other Identifiers

PMNIDAT#xx/2012

Identifier Type: -

Identifier Source: org_study_id