Back to resultsEfficacy of Gabapentin in Alcohol Dependency Treatment
Primary Purpose
Alcohol Drinking, Heavy Drinking
Status
Completed
Phase
Phase 3
Locations
Thailand
Study Type
Interventional
Intervention
Gabapentin 300mg
Placebo oral capsule
Sponsored by
About this trial
This is an interventional treatment trial for Alcohol Drinking
Eligibility Criteria
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.
Sites / Locations
- Princess Mother National Institute on Drug Abuse and Treatment
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Gabapentin
Control
Arm Description
300 mg per day once daily before bedtime
Capsule identical to the experimental arm, one tablet once daily before bedtime
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT03274167
First Posted
August 29, 2017
Last Updated
September 1, 2017
Sponsor
Chulalongkorn University
Collaborators
Princess Mother National Institute on Drug Abuse and Treatment
1. Study Identification
Unique Protocol Identification Number
NCT03274167
Brief Title
Efficacy of Gabapentin in Alcohol Dependency Treatment
Official Title
Efficacy of Gabapentin in Alcohol Dependency Treatment: a Double-blinded Randomized Placebo-controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
January 2012 (Actual)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chulalongkorn University
Collaborators
Princess Mother National Institute on Drug Abuse and Treatment
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Drinking, Heavy Drinking
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Allocation
Randomized
Enrollment
112 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Gabapentin
Arm Type
Experimental
Arm Description
300 mg per day once daily before bedtime
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Capsule identical to the experimental arm, one tablet once daily before bedtime
Intervention Type
Drug
Intervention Name(s)
Gabapentin 300mg
Intervention Type
Drug
Intervention Name(s)
Placebo oral capsule
Primary Outcome Measure Information:
Title
Frequency of heavy drinking
Description
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.
Time Frame
weekly for 12 weeks
Secondary Outcome Measure Information:
Title
Frequency of drinking
Description
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.
Time Frame
weekly for 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sumnao Nilaban
Organizational Affiliation
Princess Mother National Institute on Drug Abuse and Treatment
Official's Role
Principal Investigator
Facility Information:
Facility Name
Princess Mother National Institute on Drug Abuse and Treatment
City
Pathum Thani
Country
Thailand
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Efficacy of Gabapentin in Alcohol Dependency Treatment
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