Status:
COMPLETED
Efficacy of Topiramate for Hospitalized Patients With Alcoholism
Lead Sponsor:
Chiang Mai University
Conditions:
Alcohol Dependence
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
PHASE3
Brief Summary
This is a 12-Week, randomized controlled study of topiramate in hospitalized patients with alcoholism
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT01145677
Start Date
June 1 2010
End Date
June 1 2011
Last Update
June 23 2011
Active Locations (4)
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1
Chiang Mai Drug Dependence Treatment Center
Maerim, Chiang Mai, Thailand, 50180
2
Maharaj Nakorn Chiang Mai Hospital
Muang, Chiang Mai, Thailand, 50200
3
Suanprung Psychiatric Hospital
Muang, ChiangMai, Thailand, 50100
4
Maharaj Nakorn Chiang Mai Hospital
Muang, ChiangMai, Thailand, 50200