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
  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:


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
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: 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 July 29, 2014