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Efficacy of Topiramate for Hospitalized Patients With Alcoholism

Information source: Chiang Mai University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Alcohol Dependence

Intervention: Topiramate (Drug)

Phase: Phase 2/Phase 3

Status: Completed

Sponsored by: Chiang Mai University

Official(s) and/or principal investigator(s):
Surinporn Likhitsathian, MD, Principal Investigator, Affiliation: Department of Psychiatry, Faculty of Medicine, Chiang Mai University

Summary

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

Clinical Details

Official title: Efficacy of Topiramate for Hospitalized Patients With Alcoholism: a 12-Week Randomized, Placebo-Controlled Trial

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Alcohol drink/day

Secondary outcome: Common adverse effect

Eligibility

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Chiang Mai Drug Dependence Treatment Center, Maerim, Chiang Mai 50180, Thailand

Maharaj Nakorn Chiang Mai Hospital, Muang, Chiang Mai 50200, Thailand

Maharaj Nakorn Chiang Mai Hospital, Muang, ChiangMai 50200, Thailand

Suanprung Psychiatric Hospital, Muang, ChiangMai 50100, Thailand

Additional Information

Starting date: June 2010
Last updated: June 22, 2011

Page last updated: August 23, 2015

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