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

Phase 4

• Conditions: Alcohol Dependence
• Interventions: Drug: Topiramate

• Registration Number: NCT01135602
• Lead Sponsor: Chiang Mai University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-06
• Study First Submitted: 2010-06-02
• Study First Submitted QC: 2010-06-02
• Study First Posted: 2010-06-03
• Study Start: 2010-07
• Last Update Submitted: 2011-08-12
• Last Update Posted: 2011-08-15
• Primary Completion: 2012-03
• Study Completion: 2012-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Topiramate	Topiramate	1 group

Primary Outcome Measures

Name	Time	Method
Cognition	12 weeks	Cognition will be assessed by the use of Montreal Cognitive Assessment (MoCA)

Secondary Outcome Measures

Name	Time	Method
Alcohol drink/day	12 weeks	Alcohol drink/day assessed by the use of Timeline Followback (TLFB)

Trial Locations

Locations (1)

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