NCT01135602

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jul 2010

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 2, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 3, 2010

Completed
28 days until next milestone

Study Start

First participant enrolled

July 1, 2010

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

August 15, 2011

Status Verified

June 1, 2010

Enrollment Period

1.7 years

First QC Date

June 2, 2010

Last Update Submit

August 12, 2011

Conditions

Alcohol Dependence

Keywords

Alcohol dependenceAlcoholismTopiramate

Outcome Measures

Primary Outcomes (1)

  • Cognition

    Cognition will be assessed by the use of Montreal Cognitive Assessment (MoCA)

    12 weeks

Secondary Outcomes (1)

  • Alcohol drink/day

    12 weeks

Study Arms (1)

Topiramate

EXPERIMENTAL

1 group

Drug: Topiramate

Interventions

TopiramateDRUG

Topiramate 50-300 mg/day Orally Twice per day

Also known as: Topamax
Topiramate

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Maharaj Nakorn Chiang Mai Hospital

Muang, Chiang Mai, 50200, Thailand

NOT YET RECRUITING

Maharaj Nakorn Chiang Mai Hospital

Muang, Chiang Mai, 50200, Thailand

RECRUITING

MeSH Terms

Conditions

Alcoholism

Interventions

Topiramate

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

FructoseHexosesMonosaccharidesSugarsCarbohydratesKetoses

Study Officials

  • Manit Srisurapanont, MD

    Department of Psychiatry, Faculty of Medicine, Chiang Mai University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Manit Srisurapanont, MD

CONTACT

6653945422msrisu@yahoo.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 2, 2010

First Posted

June 3, 2010

Study Start

July 1, 2010

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

August 15, 2011

Record last verified: 2010-06

Locations

TH(2)