Efficacy of Topiramate for Hospitalized Patients With Alcoholism (ETHoPA-R)

June 22, 2011 updated by: Chiang Mai University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Chiang Mai
      • Maerim, Chiang Mai, Thailand, 50180
        • Chiang Mai Drug Dependence Treatment Center
      • Muang, Chiang Mai, Thailand, 50200
        • Maharaj Nakorn Chiang Mai Hospital
    • ChiangMai
      • Muang, ChiangMai, Thailand, 50100
        • Suanprung Psychiatric Hospital
      • Muang, ChiangMai, Thailand, 50200
        • Maharaj Nakorn Chiang Mai Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Topiramate
Drug: Topiramate
Topiramate 100-300 mg/day orally twice per day
Other Names:
  • Topamax

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Alcohol drink/day
Time Frame: 12 weeks
Alcohol drink/day assessed by the use of time line follow back
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Common adverse effect
Time Frame: 12 week
Common adverse effect will be assessed by the use of questionaire and self-report
12 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chiang Mai University

Investigators

  • Principal Investigator: Surinporn Likhitsathian, MD, Department of Psychiatry, Faculty of Medicine, Chiang Mai University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

June 16, 2010

First Submitted That Met QC Criteria

June 16, 2010

First Posted (Estimate)

June 17, 2010

Study Record Updates

Last Update Posted (Estimate)

June 23, 2011

Last Update Submitted That Met QC Criteria

June 22, 2011

Last Verified

June 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • THoPA-R

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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