Efficacy of Topiramate for Hospitalized Patients With Alcoholism (ETHoPA-R)

Chiang Mai University

Status and phase

Completed

Phase 3

Phase 2

Conditions

Alcohol Dependence

Treatments

Drug: Topiramate

Study type

Interventional

Funder types

Other

Identifiers

THoPA-R

Details and patient eligibility

About

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

Enrollment

90 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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