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OpenTrials
Completed

NCT Number: NCT03274167

Efficacy of Gabapentin in Alcohol Dependency Treatment

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.

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Key information

Conditions

Alcohol Drinking Behavior Drinking Behavior Heavy Drinking

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Princess Mother National Institute on Drug Abuse and Treatment

Pathum Thani, Thailand

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Gabapentin 300mg

Drug

Placebo oral capsule

Drug

Primary outcomes

  1. Frequency of heavy drinking

    Time frame: weekly for 12 weeks

    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.

Secondary outcomes

  1. Frequency of drinking

    Time frame: weekly for 12 weeks

    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.

Sponsors and collaborators

Lead sponsor

Chulalongkorn University

Other

Collaborators

  • Princess Mother National Institute on Drug Abuse and Treatment

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Sep 6, 2017
Registry last updated
Sep 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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