Efficacy of Gabapentin in Alcohol Dependency Treatment

Alcohol Drinking Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03274167
• Other study ID #: PMNIDAT#xx/2012
• Status: Completed
• Phase: Phase 3
• First received: August 29, 2017
• Last updated: September 1, 2017
• Start date: January 2012
• Est. completion date: December 2014

Study information

• Verified date: September 2017
• Source: Chulalongkorn University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcoholism
• Heavy Drinking

Intervention

Drug:
• Gabapentin 300mg

• Placebo oral capsule

Locations

Country	Name	City	State
Thailand	Princess Mother National Institute on Drug Abuse and Treatment	Pathum Thani

Sponsors (2)

Lead Sponsor	Collaborator
Chulalongkorn University	Princess Mother National Institute on Drug Abuse and Treatment

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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