Efficacy of Topiramate for Hospitalized Patients With Alcoholism

Alcohol Dependence Clinical Trial

— ETHoPA-R  

Official title:

Efficacy of Topiramate for Hospitalized Patients With Alcoholism: a 12-Week Randomized, Placebo-Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01145677
• Other study ID #: THoPA-R
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: June 16, 2010
• Last updated: June 22, 2011
• Start date: June 2010
• Est. completion date: June 2011

Study information

• Verified date: June 2010
• Source: Chiang Mai University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ministry of Public Health
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: June 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcohol Dependence
• Alcoholism

Intervention

Drug:
• Topiramate
Topiramate 100-300 mg/day orally twice per day

Locations

Country	Name	City	State
Thailand	Chiang Mai Drug Dependence Treatment Center	Maerim	Chiang Mai
Thailand	Maharaj Nakorn Chiang Mai Hospital	Muang	Chiang Mai
Thailand	Maharaj Nakorn Chiang Mai Hospital	Muang	ChiangMai
Thailand	Suanprung Psychiatric Hospital	Muang	ChiangMai

Sponsors (1)

Lead Sponsor	Collaborator
Chiang Mai University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alcohol drink/day	Alcohol drink/day assessed by the use of time line follow back	12 weeks	No
Secondary	Common adverse effect	Common adverse effect will be assessed by the use of questionaire and self-report	12 week	Yes