Efficacy of Topiramate for Hospitalized Patients With Alc... | NCT01145677

Studies
Efficacy of Topiramate for Hospitalized Patients With Alcoholism

NCT01145677

Sponsor

Chiang Mai University

Status

Completed

Last Update Posted

Jun 23, 2011Estimated

Enrollment

90Actual

Phase

Phase 2Phase 3

Conditions

Alcohol Dependence

Interventions

Topiramate

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2010

Primary Completion Date

Mar 2011Actual

Completion Date

Jun 2011Actual

First Submitted Date

Jun 16, 2010

First Submission Date that Met QC Criteria

Jun 16, 2010

First Posted Date

Jun 17, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 22, 2011

Last Update Posted Date

Jun 23, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

90Actual

Label	Type	Description	Intervention Names
Topiramate	Experimental		Drug: Topiramate

Name	Type	Description	Arm Group Labels	Other Names
Topiramate	Drug	Topiramate 100-300 mg/day orally twice per day	Topiramate

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Surinporn Likhitsathian, MD	Department of Psychiatry, Faculty of Medicine, Chiang Mai University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chiang Mai Drug Dependence Treatment Center		Maerim	Chiang Mai	50180	Thailand
Maharaj Nakorn Chiang Mai Hospital

Condition Browse Module

MeSH Terms

ID	Term
D000437	Alcoholism

Ancestor Terms

ID	Term
D019973	Alcohol-Related Disorders
D019966	Substance-Related Disorders
D064419	Chemically-Induced Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Term
D005632	Fructose
D006601	Hexoses
D009005	Monosaccharides
D000073893	Sugars
D002241