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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by Chiang Mai University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Chiang Mai University
ClinicalTrials.gov Identifier:
NCT01135602
First received: June 2, 2010
Last updated: August 12, 2011
Last verified: June 2010
History of Changes
  Purpose

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


Condition Intervention Phase
Alcohol Dependence
 Drug: Topiramate
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Topiramate for Hospitalized Patients With Alcoholism: a 12-Week Open-Label Study

Resource links provided by NLM:

MedlinePlus related topics: Alcoholism
Drug Information available for: Topiramate
U.S. FDA Resources

Further study details as provided by Chiang Mai University:

Primary Outcome Measures:
  • Cognition [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Cognition will be assessed by the use of Montreal Cognitive Assessment (MoCA)


Secondary Outcome Measures:
  • Alcohol drink/day [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Alcohol drink/day assessed by the use of Timeline Followback (TLFB)


Estimated Enrollment: 150
Study Start Date: July 2010
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Topiramate
1 group
 Drug: Topiramate
Topiramate 50-300 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 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01135602

Contacts
Contact: Manit Srisurapanont, MD 6653945422 msrisu@yahoo.com

Locations
Thailand
Maharaj Nakorn Chiang Mai Hospital Not yet recruiting
Muang, Chiang Mai, Thailand, 50200
Contact: Manit Srisurapanont, MD     6653945422     msrisu@yahoo.com    
Sub-Investigator: Pichai Sangchanchai, MD            
Maharaj Nakorn Chiang Mai Hospital Recruiting
Muang, Chiang Mai, Thailand, 50200
Contact: Manit Srisurapanont, MD     +66-53-945422     msrisu@yahoo.com    
Principal Investigator: Manit Srisurapanont, MD            
Sponsors and Collaborators
Chiang Mai University
Investigators
Principal Investigator: Manit Srisurapanont, MD Department of Psychiatry, Faculty of Medicine, Chiang Mai University
  More Information

No publications provided

Responsible Party: Manit Srisurapanont, Department of Psychiatry, Faculty of Medicine, Chiang Mai University
ClinicalTrials.gov Identifier: NCT01135602     History of Changes
Other Study ID Numbers: THoPA-O
Study First Received: June 2, 2010
Last Updated: August 12, 2011
Health Authority: Thailand: Chiang Mai University Research Ethics Committee

Keywords provided by Chiang Mai University:
Alcohol dependence
Alcoholism
Topiramate

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related 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 May 23, 2013