<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03274167</url>
  </required_header>
  <id_info>
    <org_study_id>PMNIDAT#xx/2012</org_study_id>
    <nct_id>NCT03274167</nct_id>
  </id_info>
  <brief_title>Efficacy of Gabapentin in Alcohol Dependency Treatment</brief_title>
  <official_title>Efficacy of Gabapentin in Alcohol Dependency Treatment: a Double-blinded Randomized Placebo-controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chulalongkorn University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Princess Mother National Institute on Drug Abuse and Treatment</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Chulalongkorn University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study aims to study the effect of gabapentin on the number of alcohol drinking days and&#xD;
      heavy drinking days in the Thai clinical alcohol-dependent population by using the&#xD;
      double-blinded randomized controlled approach. One-hundred and twelve individuals with&#xD;
      alcohol dependence were randomly assigned equally into two groups including treatment with&#xD;
      gabapentin and placebo. Thirty-four patients (30.3%) completed the study protocol, i.e.&#xD;
      treatment with gabapentin at least 300 mg per day or placebo orally once a day for twelve&#xD;
      weeks. Pattern of alcohol drinking were obtained from the timelime followback. Drinking&#xD;
      behaviors were compared between the two groups by poisson repeated measures model.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2012</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">December 2014</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
  </study_design_info>
  <primary_outcome>
    <measure>Frequency of heavy drinking</measure>
    <time_frame>weekly for 12 weeks</time_frame>
    <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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Frequency of drinking</measure>
    <time_frame>weekly for 12 weeks</time_frame>
    <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.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">112</enrollment>
  <condition>Alcohol Drinking</condition>
  <condition>Heavy Drinking</condition>
  <arm_group>
    <arm_group_label>Gabapentin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>300 mg per day once daily before bedtime</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Capsule identical to the experimental arm, one tablet once daily before bedtime</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Gabapentin 300mg</intervention_name>
    <arm_group_label>Gabapentin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo oral capsule</intervention_name>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  current diagnosis of alcohol dependence&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  having major psychiatric disorders including schizophrenia, schizoaffective disorder,&#xD;
             bipolar disorder, major depressive disorder, or suicide risk based on a clinical&#xD;
             interview by attending psychiatrist&#xD;
&#xD;
          -  receiving other medications not in the protocol of the study for any reasons or having&#xD;
             history of using other substances including methamphetamine, heroin, cannabis,&#xD;
             inhalants, mitragyna speciosa (or kratom in Thai), except tobacco based on self-report&#xD;
&#xD;
          -  having a medical disease, e.g. essential hypertension, diabetes, renal (e.g., normal&#xD;
             renal test) or liver disease (e.g., liver function test was not higher than two times&#xD;
             of normal range and gamma-glutamyl transferase (GGT) is less than 800 U/L), epilepsy,&#xD;
             stroke&#xD;
&#xD;
          -  having history of alcohol withdrawal seizure or delirium based on clinical interview&#xD;
             by attending psychiatrist&#xD;
&#xD;
          -  having moderate to severe alcohol withdrawal symptoms based on score &gt;13 of the&#xD;
             Clinical Interview for Withdrawal Alcohol Arlington (CIWA - Ar) at the time of&#xD;
             recruitment&#xD;
&#xD;
          -  having cognitive impairment based on score &lt; 24 from the Mini Mental State Exam (MMSE)&#xD;
&#xD;
          -  having history of allergy to gabapentin&#xD;
&#xD;
          -  pregnancy or breast feeding.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sumnao Nilaban</last_name>
    <role>Principal Investigator</role>
    <affiliation>Princess Mother National Institute on Drug Abuse and Treatment</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Princess Mother National Institute on Drug Abuse and Treatment</name>
      <address>
        <city>Pathum Thani</city>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>August 29, 2017</study_first_submitted>
  <study_first_submitted_qc>September 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 6, 2017</study_first_posted>
  <last_update_submitted>September 1, 2017</last_update_submitted>
  <last_update_submitted_qc>September 1, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chulalongkorn University</investigator_affiliation>
    <investigator_full_name>Rasmon Kalayasiri</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alcoholism</mesh_term>
    <mesh_term>Alcohol Drinking</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gabapentin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03274167
org study id: PMNIDAT#xx/2012
nct id: NCT03274167
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
measure: Frequency of heavy drinking
time frame: weekly for 12 weeks
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.
measure: Frequency of drinking
time frame: weekly for 12 weeks
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.
arm group label: Gabapentin
arm group type: Experimental
description: 300 mg per day once daily before bedtime
arm group label: Control
arm group type: Placebo Comparator
description: Capsule identical to the experimental arm, one tablet once daily before bedtime
intervention type: Drug
intervention name: Gabapentin 300mg
arm group label: Gabapentin
intervention type: Drug
intervention name: Placebo oral capsule
arm group label: Control
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sumnao Nilaban
role: Principal Investigator
affiliation: Princess Mother National Institute on Drug Abuse and Treatment
facility: 
country: Thailand
responsible party type: Principal Investigator
investigator affiliation: Chulalongkorn University
investigator full name: Rasmon Kalayasiri
investigator title: Associate Professor
mesh term: Alcoholism
mesh term: Alcohol Drinking
mesh term: Gabapentin
sharing ipd: Undecided