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Status unknownNCT01135602THoPA-OUpdated Aug 15, 2011

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

A Phase 4 interventional study of Topiramate in Alcohol Dependence, sponsored by Chiang Mai University. Status unknown at 2 sites in Thailand. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2011-08-15.

Sponsored by Chiang Mai University · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2010), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
150
Allocation
Not applicable
Ages
18 Years to 60 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Alcohol Dependence

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Keywords

  • Alcohol dependence
  • Alcoholism
  • Topiramate
03

In context

Alcoholism

1,606 studies on the registry are indexed under Alcoholism; 329 are open to participants now.

This study's planned enrollment of 150 is above the median of 87 across 1,371 interventional studies indexed under Alcoholism.

Browse Alcoholism studies →

Lead sponsor

Chiang Mai University is the lead sponsor of 116 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
150 participants (estimated)

Study arms

  • Experimental
    Topiramate

    1 group

    Drug: Topiramate

Interventions

  • DrugTopiramate

    Topiramate 50-300 mg/day Orally Twice per day

    Also known as: Topamax

06

What researchers measure

Primary outcomes

  1. Cognition

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

    Time frame: 12 weeks

Secondary outcomes

  1. Alcohol drink/day

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

    Time frame: 12 weeks

07

Study locations

1 of 2 sites recruiting
  • Maharaj Nakorn Chiang Mai Hospital
    Muang, Chiang Mai 50200, Thailand
    • Manit Srisurapanont, MD · Contact · msrisu@yahoo.com · 6653945422
    • Pichai Sangchanchai, MD · Sub investigator
    Not yet recruiting
  • Maharaj Nakorn Chiang Mai Hospital
    Muang, Chiang Mai 50200, Thailand
    • Manit Srisurapanont, MD · Contact · msrisu@yahoo.com · +66-53-945422
    • Manit Srisurapanont, MD · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 15, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01135602
Lead sponsor
Chiang Mai University
First posted
Jun 3, 2010
Start date
Jul 2010
Primary completion
Mar 2012 (estimated)
Completion
Mar 2012 (estimated)
Last update
Aug 15, 2011

Study contacts

Manit Srisurapanont, MD
Contact
msrisu@yahoo.com
6653945422
Manit Srisurapanont, MD
principal investigator · Department of Psychiatry, Faculty of Medicine, Chiang Mai University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2010. You cannot join it, but the record below documents what was studied.

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