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

This study has been completed.
Sponsor:
Information provided by:
Chiang Mai University
ClinicalTrials.gov Identifier:
NCT01145677
First received: June 16, 2010
Last updated: June 22, 2011
Last verified: June 2010
  Purpose

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


Condition Intervention Phase
Alcohol Dependence
Drug: Topiramate
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of Topiramate for Hospitalized Patients With Alcoholism: a 12-Week Randomized, Placebo-Controlled Trial

Resource links provided by NLM:


Further study details as provided by Chiang Mai University:

Primary Outcome Measures:
  • Alcohol drink/day [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Alcohol drink/day assessed by the use of time line follow back


Secondary Outcome Measures:
  • Common adverse effect [ Time Frame: 12 week ] [ Designated as safety issue: Yes ]
    Common adverse effect will be assessed by the use of questionaire and self-report


Enrollment: 90
Study Start Date: June 2010
Study Completion Date: June 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Topiramate Drug: Topiramate
Topiramate 100-300 mg/day orally twice per day
Other Name: Topamax

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01145677

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

No publications provided

Responsible Party: Surinporn Likhitsathian, Department of Psychiatry, Faculty of Medicine, Chiang Mai University
ClinicalTrials.gov Identifier: NCT01145677     History of Changes
Other Study ID Numbers: THoPA-R
Study First Received: June 16, 2010
Last Updated: June 22, 2011
Health Authority: Thailand: Ministry of Public Health

Keywords provided by Chiang Mai University:
Alcohol dependence
Alcoholism
Topiramate

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Topiramate
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Anti-Obesity Agents

ClinicalTrials.gov processed this record on October 01, 2014