Topiramate for Hospitalized Patients With Alcoholism: a 12-week Study
NCT ID: NCT01135602
Last Updated: 2011-08-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
150 participants
INTERVENTIONAL
2010-07-31
2012-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Topiramate
1 group
Topiramate
Topiramate 50-300 mg/day Orally Twice per day
Interventions
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Topiramate
Topiramate 50-300 mg/day Orally Twice per day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* DSM-IV-TR alcohol dependence
* \>/= 35 drinks/week (male) or \>/= 28 drinks/week (female) for \>/= 1 week during four weeks prior to the admission
* AUDIT score \>/= 8
* Mild or no alcohol withdrawal
* Body mass index \> 18 kg/m2
* No pregnancy and no plan for pregnancy (female)
* Intention to decrease or stop drinking
Exclusion Criteria
* Other substance dependence, except nicotine and caffeine dependence, during 6 months prior to enrollment
* Taking antipsychotics, mood stabilizers, anticonvulsants, opioid analgesics, systematic steroids, carbonic anhydrase inhibitors, hydrochlorthiazide, metformin, pioglitazone, or disulfiram
* Moderate to high risk of suicide
* Medical history of narrow angle glaucoma, renal impairment, kidney stones, and seizures
* Unstable medical conditions
* Plan to receive a formal treatment for alcoholism from other treatment settings
* Under legal process
* Pregnancy and nursing woman
* Abnormal laboratory tests, including blood urea nitrogen, creatinine, electrolytes, and fasting blood sugar
18 Years
60 Years
ALL
No
Sponsors
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Chiang Mai University
OTHER
Responsible Party
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Department of Psychiatry, Faculty of Medicine, Chiang Mai University
Principal Investigators
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Manit Srisurapanont, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Psychiatry, Faculty of Medicine, Chiang Mai University
Locations
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Maharaj Nakorn Chiang Mai Hospital
Muang, Chiang Mai, Thailand
Maharaj Nakorn Chiang Mai Hospital
Muang, Chiang Mai, Thailand
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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THoPA-O
Identifier Type: -
Identifier Source: org_study_id
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