Efficacy of Topiramate for Hospitalized Patients With Alcoholism

Phase 2

Completed

• Conditions: Alcohol Dependence
• Interventions: Drug: Topiramate

• Registration Number: NCT01145677
• Lead Sponsor: Chiang Mai University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-06
• Study Start: 2010-06
• Study First Submitted: 2010-06-16
• Study First Submitted QC: 2010-06-16
• Study First Posted: 2010-06-17
• Primary Completion: 2011-03
• Study Completion: 2011-06
• Last Update Submitted: 2011-06-22
• Last Update Posted: 2011-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Topiramate	Topiramate	-

Primary Outcome Measures

Name	Time	Method
Alcohol drink/day	12 weeks	Alcohol drink/day assessed by the use of time line follow back

Secondary Outcome Measures

Name	Time	Method
Common adverse effect	12 week	Common adverse effect will be assessed by the use of questionaire and self-report

Trial Locations

Locations (3)

Suanprung Psychiatric Hospital; 🇹🇭 Muang, ChiangMai, Thailand

Chiang Mai Drug Dependence Treatment Center; 🇹🇭 Maerim, Chiang Mai, Thailand

Maharaj Nakorn Chiang Mai Hospital; 🇹🇭 Muang, ChiangMai, Thailand