Efficacy of Topiramate for Hospitalized Patients With Alcoholism

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

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01145677

Acronym

ETHoPA-R

Enrollment

Registered

2010-06-17

Start date

2010-06-30

Completion date

2011-06-30

Last updated

2011-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Dependence

Keywords

Alcohol dependence, Alcoholism, Topiramate

Brief summary

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

Interventions

DRUGTopiramate

Topiramate 100-300 mg/day orally twice per day

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Alcohol drink/day	12 weeks	Alcohol drink/day assessed by the use of time line follow back

Secondary

Measure	Time frame	Description
Common adverse effect	12 week	Common adverse effect will be assessed by the use of questionaire and self-report

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026