Efficacy of Topiramate for Hospitalized Patients With Alcoholism
ETHoPA-R
1 other identifier
interventional
90
1 country
4
Brief Summary
This is a 12-Week, randomized controlled study of topiramate in hospitalized patients with alcoholism
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jun 2010
Shorter than P25 for phase_2
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2010
CompletedFirst Submitted
Initial submission to the registry
June 16, 2010
CompletedFirst Posted
Study publicly available on registry
June 17, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedJune 23, 2011
June 1, 2010
9 months
June 16, 2010
June 22, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Alcohol drink/day
Alcohol drink/day assessed by the use of time line follow back
12 weeks
Secondary Outcomes (1)
Common adverse effect
12 week
Study Arms (1)
Topiramate
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Chiang Mai Drug Dependence Treatment Center
Maerim, Chiang Mai, 50180, Thailand
Maharaj Nakorn Chiang Mai Hospital
Muang, Chiang Mai, 50200, Thailand
Suanprung Psychiatric Hospital
Muang, ChiangMai, 50100, Thailand
Maharaj Nakorn Chiang Mai Hospital
Muang, ChiangMai, 50200, Thailand
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Surinporn Likhitsathian, MD
Department of Psychiatry, Faculty of Medicine, Chiang Mai University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 16, 2010
First Posted
June 17, 2010
Study Start
June 1, 2010
Primary Completion
March 1, 2011
Study Completion
June 1, 2011
Last Updated
June 23, 2011
Record last verified: 2010-06