Efficacy of Topiramate for Hospitalized Patients With Alcoholism

NCT ID: NCT01145677

Last Updated: 2011-06-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2011-06-30

Brief Summary

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This is a 12-Week, randomized controlled study of topiramate in hospitalized patients with alcoholism

Detailed Description

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Conditions

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Alcohol Dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Topiramate

Group Type EXPERIMENTAL

Topiramate

Intervention Type DRUG

Topiramate 100-300 mg/day orally twice per day

Interventions

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Topiramate

Topiramate 100-300 mg/day orally twice per day

Intervention Type DRUG

Other Intervention Names

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Topamax

Eligibility Criteria

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Inclusion Criteria

* patients hospitalized due to alcohol-related problem
* DSM-IV-TR alcohol dependence
* for male: history of alcohol drink \>=35/week, female: history of alcohol drink \>=28/week for at least 1 week during four weeks prior to the admission
* AUDIT score at least 8
* mild or no alcohol withdrawal symptom
* BMI \> 18 kg/m2
* not pregnant and no plan for pregnancy
* 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, systemic steroids, carbonic anhydrase inhibitors, hydrochlorthiazide, metformin, pioglitazone, or disulfiram
* unstable medical condition
* medical history of narrow angle glaucoma, renal impairment, kidney stones, and seizures
* moderate to high risk of suicide
* under legal process
* plan to receive a formal treatment for alcoholism from other treatment settings
* pregnancy and nursing woman
* abnormal laboratory tests, including blood urea nitrogen, creatinine, electrolytes, and fasting blood sugar
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chiang Mai University

OTHER

Sponsor Role lead

Responsible Party

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Department of Psychiatry, Faculty of Medicine, Chiang Mai University

Principal Investigators

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Surinporn Likhitsathian, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Psychiatry, Faculty of Medicine, Chiang Mai University

Locations

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Chiang Mai Drug Dependence Treatment Center

Maerim, Chiang Mai, Thailand

Site Status

Maharaj Nakorn Chiang Mai Hospital

Muang, Chiang Mai, Thailand

Site Status

Suanprung Psychiatric Hospital

Muang, ChiangMai, Thailand

Site Status

Maharaj Nakorn Chiang Mai Hospital

Muang, ChiangMai, Thailand

Site Status

Countries

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Thailand

Other Identifiers

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THoPA-R

Identifier Type: -

Identifier Source: org_study_id

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