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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01145677
Recruitment Status : Completed
First Posted : June 17, 2010
Last Update Posted : June 23, 2011
Information provided by:
Chiang Mai University

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

Condition or disease Intervention/treatment Phase
Alcohol Dependence Drug: Topiramate Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of Topiramate for Hospitalized Patients With Alcoholism: a 12-Week Randomized, Placebo-Controlled Trial
Study Start Date : June 2010
Actual Primary Completion Date : March 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Topiramate
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Topiramate Drug: Topiramate
Topiramate 100-300 mg/day orally twice per day
Other Name: Topamax

Primary Outcome Measures :
  1. Alcohol drink/day [ Time Frame: 12 weeks ]
    Alcohol drink/day assessed by the use of time line follow back

Secondary Outcome Measures :
  1. Common adverse effect [ Time Frame: 12 week ]
    Common adverse effect will be assessed by the use of questionaire and self-report

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01145677

Chiang Mai Drug Dependence Treatment Center
Maerim, Chiang Mai, Thailand, 50180
Maharaj Nakorn Chiang Mai Hospital
Muang, Chiang Mai, Thailand, 50200
Suanprung Psychiatric Hospital
Muang, ChiangMai, Thailand, 50100
Maharaj Nakorn Chiang Mai Hospital
Muang, ChiangMai, Thailand, 50200
Sponsors and Collaborators
Chiang Mai University
Principal Investigator: Surinporn Likhitsathian, MD Department of Psychiatry, Faculty of Medicine, Chiang Mai University

Responsible Party: Surinporn Likhitsathian, Department of Psychiatry, Faculty of Medicine, Chiang Mai University Identifier: NCT01145677     History of Changes
Other Study ID Numbers: THoPA-R
First Posted: June 17, 2010    Key Record Dates
Last Update Posted: June 23, 2011
Last Verified: June 2010

Keywords provided by Chiang Mai University:
Alcohol dependence

Additional relevant MeSH terms:
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Anti-Obesity Agents