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

June 2, 2010
August 12, 2011
July 2010
March 2012   (final data collection date for primary outcome measure)
Cognition [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Cognition will be assessed by the use of Montreal Cognitive Assessment (MoCA)
Same as current
Complete list of historical versions of study NCT01135602 on ClinicalTrials.gov Archive Site
Alcohol drink/day [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Alcohol drink/day assessed by the use of Timeline Followback (TLFB)
Same as current
Not Provided
Not Provided
 
Topiramate for Hospitalized Patients With Alcoholism: a 12-week Study
Topiramate for Hospitalized Patients With Alcoholism: a 12-Week Open-Label Study

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

Not Provided
Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Alcohol Dependence
Drug: Topiramate
Topiramate 50-300 mg/day Orally Twice per day
Other Name: Topamax
Experimental: Topiramate
1 group
Intervention: Drug: Topiramate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
March 2012
March 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact: Manit Srisurapanont, MD 6653945422 msrisu@yahoo.com
Thailand
 
NCT01135602
THoPA-O
No
Manit Srisurapanont, Department of Psychiatry, Faculty of Medicine, Chiang Mai University
Chiang Mai University
Not Provided
Principal Investigator: Manit Srisurapanont, MD Department of Psychiatry, Faculty of Medicine, Chiang Mai University
Chiang Mai University
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP