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

Alcohol Dependence Clinical Trial

— THoPA-O  

Official title:

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01135602
• Other study ID #: THoPA-O
• Status: Unknown status
• Phase: Phase 4
• First received: June 2, 2010
• Last updated: August 12, 2011
• Start date: July 2010
• Est. completion date: March 2012

Study information

• Verified date: June 2010
• Source: Chiang Mai University
• Contact: Manit Srisurapanont, MD
• Phone: 6653945422
• Email: msrisu[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 150
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Dependence
• Alcoholism

Intervention

Drug:
• Topiramate
Topiramate 50-300 mg/day Orally Twice per day

Locations

Country	Name	City	State
Thailand	Maharaj Nakorn Chiang Mai Hospital	Muang	Chiang Mai
Thailand	Maharaj Nakorn Chiang Mai Hospital	Muang	Chiang Mai

Sponsors (1)

Lead Sponsor	Collaborator
Chiang Mai University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognition	Cognition will be assessed by the use of Montreal Cognitive Assessment (MoCA)	12 weeks
Secondary	Alcohol drink/day	Alcohol drink/day assessed by the use of Timeline Followback (TLFB)	12 weeks