Topiramate for Hospitalized Patients With Alcoholism: a 12-week Study

Topiramate for Hospitalized Patients With Alcoholism: a 12-Week Open-Label Study

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01135602

Acronym

THoPA-O

Enrollment

150

Registered

2010-06-03

Start date

2010-07-31

Completion date

2012-03-31

Last updated

2011-08-15

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

12-week, open-label study of topiramate in hospitalized patients with alcoholism

Interventions

DRUGTopiramate

Topiramate 50-300 mg/day Orally Twice per day

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Inclusion criteria

* Patients hospitalized due to alcohol-related problems * DSM-IV-TR alcohol dependence * \>/= 35 drinks/week (male) or \>/= 28 drinks/week (female) for \>/= 1 week during four weeks prior to the admission * AUDIT score \>/= 8 * Mild or no alcohol withdrawal * Body mass index \> 18 kg/m2 * No pregnancy and no plan for pregnancy (female) * 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, systematic steroids, carbonic anhydrase inhibitors, hydrochlorthiazide, metformin, pioglitazone, or disulfiram * Moderate to high risk of suicide * Medical history of narrow angle glaucoma, renal impairment, kidney stones, and seizures * Unstable medical conditions * Plan to receive a formal treatment for alcoholism from other treatment settings * Under legal process * Pregnancy and nursing woman * Abnormal laboratory tests, including blood urea nitrogen, creatinine, electrolytes, and fasting blood sugar

Design outcomes

Primary

Measure	Time frame	Description
Cognition	12 weeks	Cognition will be assessed by the use of Montreal Cognitive Assessment (MoCA)

Secondary

Measure	Time frame	Description
Alcohol drink/day	12 weeks	Alcohol drink/day assessed by the use of Timeline Followback (TLFB)

Countries

Thailand

Contacts

Primary ContactManit Srisurapanont, MD

msrisu@yahoo.com6653945422

Outcome results

None listed

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