Efficacy of Gabapentin in Alcohol Dependency Treatment

NCT03274167 | Completed Phase 3

• 1 other identifier: PMNIDAT#xx/2012
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Frequency of drinking

  weekly for 12 weeks

Study Arms (2)

Gabapentin

EXPERIMENTAL

300 mg per day once daily before bedtime

Drug: Gabapentin 300mg

Control

PLACEBO COMPARATOR

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

Drug: Placebo oral capsule

Interventions

Gabapentin 300mg DRUG

Gabapentin

Placebo oral capsule DRUG

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• current diagnosis of alcohol dependence

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chulalongkorn University: lead
• Princess Mother National Institute on Drug Abuse and Treatment: collaborator

Study Sites (1)

Princess Mother National Institute on Drug Abuse and Treatment

Pathum Thani, Thailand

Location

MeSH Terms

Conditions

Alcohol Drinking

Interventions

Gabapentin

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Sumnao Nilaban

  Princess Mother National Institute on Drug Abuse and Treatment

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 29, 2017
• First Posted: September 6, 2017
• Study Start: January 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: September 6, 2017

Record last verified: 2017-09

Locations

TH (1)