Efficacy of Topiramate for Hospitalized… | Clinical Trial

Key information

Conditions

Alcohol Dependence Alcohol-Related Disorders Alcoholism Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Topiramate

Drug

Topiramate 100-300 mg/day orally twice per day

Other names: Topamax

Primary outcomes

Alcohol drink/day

Time frame: 12 weeks

Alcohol drink/day assessed by the use of time line follow back

Secondary outcomes

Common adverse effect

Time frame: 12 week

Common adverse effect will be assessed by the use of questionaire and self-report

Sponsors and collaborators

Lead sponsor

Chiang Mai University

Other

Registry information

Official study title

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

Acronym: ETHoPA-R

Important dates

Study start: 2010
Primary completion: 2011
Study completion: 2011
First posted: Jun 17, 2010
Registry last updated: Jun 23, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed