Status:
UNKNOWN
Topiramate for Hospitalized Patients With Alcoholism: a 12-week Study
Lead Sponsor:
Chiang Mai University
Conditions:
Alcohol Dependence
Eligibility:
All Genders
18-60 years
Phase:
PHASE4
Brief Summary
12-week, open-label study of topiramate in hospitalized patients with alcoholism
Eligibility Criteria
Inclusion
- Patients hospitalized due to alcohol-related problems
- 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
- 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, 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
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2012
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT01135602
Start Date
July 1 2010
End Date
March 1 2012
Last Update
August 15 2011
Active Locations (2)
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1
Maharaj Nakorn Chiang Mai Hospital
Muang, Chiang Mai, Thailand, 50200
2
Maharaj Nakorn Chiang Mai Hospital
Muang, Chiang Mai, Thailand, 50200