Topiramate for Hospitalized Patients With Alcoholism: a 12-week Study

• Status: Unknown status
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: All

Summary

12-week, open-label study of topiramate in hospitalized patients with alcoholism

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chiang Mai University
• Treatments: Topiramate

Criteria

Inclusion Criteria:

• 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 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, 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