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

Primary Purpose

Alcohol Dependence

Status
Unknown status
Phase
Phase 4
Locations
Thailand
Study Type
Interventional
Intervention
Topiramate
Sponsored by
Chiang Mai University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Dependence focused on measuring Alcohol dependence, Alcoholism, Topiramate

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Maharaj Nakorn Chiang Mai Hospital
  • Maharaj Nakorn Chiang Mai HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Topiramate

Arm Description

1 group

Outcomes

Primary Outcome Measures

Cognition
Cognition will be assessed by the use of Montreal Cognitive Assessment (MoCA)

Secondary Outcome Measures

Alcohol drink/day
Alcohol drink/day assessed by the use of Timeline Followback (TLFB)

Full Information

First Posted
June 2, 2010
Last Updated
August 12, 2011
Sponsor
Chiang Mai University
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1. Study Identification

Unique Protocol Identification Number
NCT01135602
Brief Title
Topiramate for Hospitalized Patients With Alcoholism: a 12-week Study
Acronym
THoPA-O
Official Title
Topiramate for Hospitalized Patients With Alcoholism: a 12-Week Open-Label Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2010
Overall Recruitment Status
Unknown status
Study Start Date
July 2010 (undefined)
Primary Completion Date
March 2012 (Anticipated)
Study Completion Date
March 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Chiang Mai University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Dependence
Keywords
Alcohol dependence, Alcoholism, Topiramate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Topiramate
Arm Type
Experimental
Arm Description
1 group
Intervention Type
Drug
Intervention Name(s)
Topiramate
Other Intervention Name(s)
Topamax
Intervention Description
Topiramate 50-300 mg/day Orally Twice per day
Primary Outcome Measure Information:
Title
Cognition
Description
Cognition will be assessed by the use of Montreal Cognitive Assessment (MoCA)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Alcohol drink/day
Description
Alcohol drink/day assessed by the use of Timeline Followback (TLFB)
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Manit Srisurapanont, MD
Phone
6653945422
Email
msrisu@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manit Srisurapanont, MD
Organizational Affiliation
Department of Psychiatry, Faculty of Medicine, Chiang Mai University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maharaj Nakorn Chiang Mai Hospital
City
Muang
State/Province
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manit Srisurapanont, MD
Phone
6653945422
Email
msrisu@yahoo.com
First Name & Middle Initial & Last Name & Degree
Pichai Sangchanchai, MD
Facility Name
Maharaj Nakorn Chiang Mai Hospital
City
Muang
State/Province
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manit Srisurapanont, MD
Phone
+66-53-945422
Email
msrisu@yahoo.com
First Name & Middle Initial & Last Name & Degree
Manit Srisurapanont, MD

12. IPD Sharing Statement

Learn more about this trial

Topiramate for Hospitalized Patients With Alcoholism: a 12-week Study

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