Efficacy of Topiramate for Hospitalized Patients With Alcoholism

• Status: Completed
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a 12-Week, randomized controlled study of topiramate in hospitalized patients with alcoholism

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chiang Mai University
• Treatments: Topiramate

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