Efficacy of Gabapentin in Alcohol Dependency Treatment

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

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 Overview

• Status: Completed
• Conditions: Alcohol Drinking; Heavy Drinking
• Intervention / Treatment: Drug: Placebo oral capsule; Drug: Gabapentin 300mg

• Study Type: Interventional
• Enrollment (Actual): 112
• Phase: Phase 3

Contacts and Locations

Study Locations

• Thailand
  • Pathum Thani, Thailand
    • Princess Mother National Institute on Drug Abuse and Treatment

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Gabapentin; 300 mg per day once daily before bedtime	Drug: Gabapentin 300mg
Placebo Comparator: Control; Capsule identical to the experimental arm, one tablet once daily before bedtime	Drug: Placebo oral capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	weekly for 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	weekly for 12 weeks

Collaborators and Investigators

• Sponsor: Chulalongkorn University
• Collaborators: Princess Mother National Institute on Drug Abuse and Treatment
• Investigators: Principal Investigator: Sumnao Nilaban, Princess Mother National Institute on Drug Abuse and Treatment

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2012
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: August 29, 2017
• First Submitted That Met QC Criteria: September 1, 2017
• First Posted (Actual): September 6, 2017

Study Record Updates

• Last Update Posted (Actual): September 6, 2017
• Last Update Submitted That Met QC Criteria: September 1, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Drinking Behavior; Alcohol-Related Disorders; Substance-Related Disorders; Alcohol Drinking; Alcoholism; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Tranquilizing Agents; Psychotropic Drugs; Anti-Anxiety Agents; Anticonvulsants; Antimanic Agents; Gabapentin
• Other Study ID Numbers: PMNIDAT#xx/2012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No