Topiramate for Hospitalized Patients With Alcoholism: a 12-week Study (THoPA-O)

August 12, 2011 updated by: Chiang Mai University

Topiramate for Hospitalized Patients With Alcoholism: a 12-Week Open-Label Study

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Phase 4

Contacts and Locations

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

Study Contact

  • Name: Manit Srisurapanont, MD
  • Phone Number: 6653945422
  • Email: msrisu@yahoo.com

Study Locations

  • Thailand
    • Chiang Mai
      • Muang, Chiang Mai, Thailand, 50200
        • Not yet recruiting
        • Maharaj Nakorn Chiang Mai Hospital
        • Contact:
        • Sub-Investigator:
          • Pichai Sangchanchai, MD
      • Muang, Chiang Mai, Thailand, 50200
        • Recruiting
        • Maharaj Nakorn Chiang Mai Hospital
        • Contact:
        • Principal Investigator:
          • Manit Srisurapanont, MD

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 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 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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Topiramate
1 group
Drug: Topiramate
Topiramate 50-300 mg/day Orally Twice per day
Other Names:
  • Topamax

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognition
Time Frame: 12 weeks
Cognition will be assessed by the use of Montreal Cognitive Assessment (MoCA)
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Alcohol drink/day
Time Frame: 12 weeks
Alcohol drink/day assessed by the use of Timeline Followback (TLFB)
12 weeks

Collaborators and Investigators

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

Sponsor

Chiang Mai University

Investigators

  • Principal Investigator: Manit Srisurapanont, 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

July 1, 2010

Primary Completion (Anticipated)

March 1, 2012

Study Completion (Anticipated)

March 1, 2012

Study Registration Dates

First Submitted

June 2, 2010

First Submitted That Met QC Criteria

June 2, 2010

First Posted (Estimate)

June 3, 2010

Study Record Updates

Last Update Posted (Estimate)

August 15, 2011

Last Update Submitted That Met QC Criteria

August 12, 2011

Last Verified

June 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • THoPA-O

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.

Clinical Trials on Alcohol Dependence

Clinical Trials on Topiramate

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Canada

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe