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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2010 by Chiang Mai University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01135602
First Posted: June 3, 2010
Last Update Posted: October 12, 2017
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.
Information provided by:
Chiang Mai University
  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: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Topiramate for Hospitalized Patients With Alcoholism: a 12-Week Open-Label Study

Resource links provided by NLM:


Further study details as provided by Chiang Mai University:

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


Secondary Outcome Measures:
  • Alcohol drink/day [ Time Frame: 12 weeks ]
    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

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
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
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 ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: June 2, 2010
First Posted: June 3, 2010
Last Update Posted: October 12, 2017
Last Verified: June 2010

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
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Anti-Obesity Agents