Back to resultsEfficacy of Topiramate for Hospitalized Patients With Alcoholism (ETHoPA-R)
Primary Purpose
Alcohol Dependence
Status
Completed
Phase
Phase 2
Locations
Thailand
Study Type
Interventional
Intervention
Topiramate
Sponsored by
About this trial
This is an interventional treatment trial for Alcohol Dependence focused on measuring Alcohol dependence, Alcoholism, Topiramate
Eligibility Criteria
Inclusion Criteria:
- patients hospitalized due to alcohol-related problem
- DSM-IV-TR alcohol dependence
- for male: history of alcohol drink >=35/week, female: history of alcohol drink >=28/week for at least 1 week during four weeks prior to the admission
- AUDIT score at least 8
- mild or no alcohol withdrawal symptom
- BMI > 18 kg/m2
- not pregnant and no plan for pregnancy
- intention to decrease or stop drinking
Exclusion Criteria:
- severe psychiatric and cognitive disorders
- other substance dependence, except nicotine and caffeine dependence, during 6 months prior to enrollment
- taking antipsychotics, mood stabilizers, anticonvulsants, opioid analgesics, systemic steroids, carbonic anhydrase inhibitors, hydrochlorthiazide, metformin, pioglitazone, or disulfiram
- unstable medical condition
- medical history of narrow angle glaucoma, renal impairment, kidney stones, and seizures
- moderate to high risk of suicide
- under legal process
- plan to receive a formal treatment for alcoholism from other treatment settings
- pregnancy and nursing woman
- abnormal laboratory tests, including blood urea nitrogen, creatinine, electrolytes, and fasting blood sugar
Sites / Locations
- Chiang Mai Drug Dependence Treatment Center
- Maharaj Nakorn Chiang Mai Hospital
- Suanprung Psychiatric Hospital
- Maharaj Nakorn Chiang Mai Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Topiramate
Arm Description
Outcomes
Primary Outcome Measures
Alcohol drink/day
Alcohol drink/day assessed by the use of time line follow back
Secondary Outcome Measures
Common adverse effect
Common adverse effect will be assessed by the use of questionaire and self-report
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01145677
Brief Title
Efficacy of Topiramate for Hospitalized Patients With Alcoholism
Acronym
ETHoPA-R
Official Title
Efficacy of Topiramate for Hospitalized Patients With Alcoholism: a 12-Week Randomized, Placebo-Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Chiang Mai University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a 12-Week, randomized controlled study of topiramate in hospitalized patients with alcoholism
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Dependence
Keywords
Alcohol dependence, Alcoholism, Topiramate
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Topiramate
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Topiramate
Other Intervention Name(s)
Topamax
Intervention Description
Topiramate 100-300 mg/day orally twice per day
Primary Outcome Measure Information:
Title
Alcohol drink/day
Description
Alcohol drink/day assessed by the use of time line follow back
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Common adverse effect
Description
Common adverse effect will be assessed by the use of questionaire and self-report
Time Frame
12 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients hospitalized due to alcohol-related problem
DSM-IV-TR alcohol dependence
for male: history of alcohol drink >=35/week, female: history of alcohol drink >=28/week for at least 1 week during four weeks prior to the admission
AUDIT score at least 8
mild or no alcohol withdrawal symptom
BMI > 18 kg/m2
not pregnant and no plan for pregnancy
intention to decrease or stop drinking
Exclusion Criteria:
severe psychiatric and cognitive disorders
other substance dependence, except nicotine and caffeine dependence, during 6 months prior to enrollment
taking antipsychotics, mood stabilizers, anticonvulsants, opioid analgesics, systemic steroids, carbonic anhydrase inhibitors, hydrochlorthiazide, metformin, pioglitazone, or disulfiram
unstable medical condition
medical history of narrow angle glaucoma, renal impairment, kidney stones, and seizures
moderate to high risk of suicide
under legal process
plan to receive a formal treatment for alcoholism from other treatment settings
pregnancy and nursing woman
abnormal laboratory tests, including blood urea nitrogen, creatinine, electrolytes, and fasting blood sugar
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Surinporn Likhitsathian, MD
Organizational Affiliation
Department of Psychiatry, Faculty of Medicine, Chiang Mai University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chiang Mai Drug Dependence Treatment Center
City
Maerim
State/Province
Chiang Mai
ZIP/Postal Code
50180
Country
Thailand
Facility Name
Maharaj Nakorn Chiang Mai Hospital
City
Muang
State/Province
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
Facility Name
Suanprung Psychiatric Hospital
City
Muang
State/Province
ChiangMai
ZIP/Postal Code
50100
Country
Thailand
Facility Name
Maharaj Nakorn Chiang Mai Hospital
City
Muang
State/Province
ChiangMai
ZIP/Postal Code
50200
Country
Thailand
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Topiramate for Hospitalized Patients With Alcoholism
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