Status:
COMPLETED
Efficacy of Gabapentin in Alcohol Dependency Treatment
Lead Sponsor:
Chulalongkorn University
Collaborating Sponsors:
Princess Mother National Institute on Drug Abuse and Treatment
Conditions:
Alcohol Drinking
Heavy Drinking
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- current diagnosis of alcohol dependence
Exclusion
- 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.
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT03274167
Start Date
January 1 2012
End Date
December 1 2014
Last Update
September 6 2017
Active Locations (1)
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1
Princess Mother National Institute on Drug Abuse and Treatment
Pathum Thani, Thailand